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European Urology Today Official newsletter of the European Association of Urology

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EAU RF supports a new registry infrastructure Prof. A. Bjartell

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Vol. 32 No.2 - March/May 2020

The Golden Age of Uroscopy

The politics of clinical trials

And other historical highlights from urology in the Netherlands

How do you prepare to get the most out of it

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Mrs. S. Collen

“Strange and unprecedented times in our history” Global pandemic forces cancellation of events, shifting priorities Prof. Christopher Chapple EAU Secretary General Sheffield (GB)

An Online Annual Congress Over the course of three days, participants can expect the same scientific quality that they would have enjoyed in Amsterdam. The days are structured similarly to a regular Annual Congress, with the Plenary and Thematic Sessions covering the same topics (See page 5).

Speakers will pre-record their lectures, and these lectures will be arranged into structured sessions with live moderation by the online session chairs. Participants can submit questions digitally allowing We currently find ourselves experiencing a very the opportunity for live discussion. Panel discussions strange and unprecedented time in modern history, will also be conducted live, where possible. Friday with significant implications at both a personal and covers the management of prostate cancer and all professional level. In the UK, routine urological work related topics like imaging and focal therapy. is no longer being carried out, the only cases that we Saturday is reserved for bladder cancer and adjacent are treating are those with clinical urgency. It has specialties and functional urology (BPE/LUTS, been interesting to discover that we have been able reconstructive surgery and gynaeco-urology). Sunday to do quite a lot of work by telephone communication features robotic and renal surgery, with case with patients, doing virtual clinics. discussions and pre-recorded surgical demonstrations from the masters of their respective I hear from many colleagues around Europe and fields. beyond that they are experiencing similar issues, although clearly there is a variable severity of the This virtual congress and its full-day plenary and problem in different regions. thematic sessions will be followed by an EAU20 Theme Week with digital evening sessions featuring Beyond urology, it is strange to cope with physical abstract presentations on andrology, imaging, distancing and it is with interest that we all await functional urology, bladder, renal, prostate and developments to see how we can get back to normal stones. This will be structured so that abstracts will be social interaction and clinical practice as some of our presented with live moderation by experts. These European countries pilot relaxation of restrictions. sessions will be grouped by theme for each day and will be followed by a relevant industry session and a Naturally, the COVID-19 crisis has had a huge effect on selection of video abstracts (See page 6). the EAU’s activities in the past months and inevitably also for the near future. Please allow me to expand a Keep an eye on www.eau20.org for the most little on our decisions related to our 35th Annual up-to-date information on the scientific programme Congress and other activities. and more. c.chapple@ uroweb.org

Spring comes to the centre of Amsterdam, 7 April 2020. Social distancing measures have made Amsterdam's normally bustling waterways a serene affair (Photo: Thomas Schlijper)

can say that all the staff have pulled together to ensure a continuation of the EAU’s projects.

Please rest assured that we are doing everything we can at the EAU to support our members: the European School of Urology will continue to train Beyond the scientific programme, the Annual urologists with more emphasis on e-learning. We Congress was also a place for the EAU’s governance: continue to offer scholarship programmes, research board meetings, new members joining offices and the fellowships and other programmes for young honouring of deceased members or prestigious prize urologists. winners. As you will have seen, the EAU is actively trying to The Offices of the EAU are already holding virtual contribute to our practice relating to COVID-19. The meetings and over the coming weeks, we will be Guidelines Offices have worked together and set up distributing to members the critical issues relating to the Guidelines Office Rapid Response Group (GORRG), Moving to a Virtual EAU20 All of this scientific content will be available online the General Assembly and the information that is putting enormous effort into revised guidelines and There were a number of difficult decisions to make after the meeting so that as members you will be able usually reported there. Several EAU Board members tools for treating patients during the pandemic. The regarding EAU20. The situation was developing to access this, even if you are unable to participate were set to step down and be replaced in Amsterdam. Patient Information group have created special rapidly in the run-up to the originally planned live. It goes without saying that we have released the They will now remain in their positions but will be informative videos on COVID-19 for our patients in Amsterdam Congress in mid-March. By 6 March, it already submitted abstracts so that everybody can joined on the Board by their intended replacements in multiple languages. You can find an overview of our had become clear to us that too many of our have the benefit of the new knowledge contained in an “-elect” capacity. This way we will ensure activities in this field on www.uroweb.org/covid19. participants and faculty were impacted by the them. This is in keeping with the EAU’s ethos of continuity within the organisation until we can Any suggestions relating to how we can more situation in their home countries and related travel providing the best quality education and support to formally relieve the Board members and Chairs of effectively contribute are much appreciated. restrictions. We decided to postpone EAU20 to the its members to aid them in providing the most up to their duties. One major consequence of the summer. On 12 March, the Dutch government had date treatment of patients. cancellation of the regular congress is that we will be I will keep you informed of all further developments decreed the cancellation of all public events and deferring the presentation of a number of awards this as we adjust to these new realities. Please get in started a series of restrictive measures which are still I trust that you will agree that the virtual congress, year and carrying them over to next year's meeting. contact with any thoughts and suggestions which you in effect at the time of writing (mid-April). whilst necessitated by this crisis, is an exciting Beyond our Annual Congress, the COVID-19 crisis has may have to c.chapple@uroweb.org. From myself opportunity. I want to congratulate Prof. Peter Albers of course impacted on the EAU and our activities, as it personally and the other members of the EAU As the situation continued to develop over the course and his team in the Scientific Congress Office along has on every aspect of all colleagues’ personal and Executive and the EAU Board, and Office members of March, and in many European countries became with our Central Office for the enormous efforts that professional lives. Certainly, there will be an impact throughout the Association, we will do our best to unbearable, it was obvious that even July was too they are putting into this innovative programme. Out on many of the other activities that the EAU had adapt to the situation and look forward to the optimistic to plan a congress with thousands of of every crisis comes interesting ideas, as we do our arranged over the next several months, but no-one continued development of the EAU. I would like to participants. With a heavy heart, but employing best to cope with the issues presented by the current knows how matters will develop until we have personally thank you for your strong support of the pragmatic reasoning, we were forced to announce crisis. effective management of the disease with a validated Association at this difficult time and I hope that you the first ever cancellation of an Annual Congress on antibody test and an effective vaccine. and your families remain well. 1 April. If this proves successful, it is very likely that in the future we shall be using digital platforms like this to At the same time, we explored the options for the provide virtual meetings in addition to our physical creation of an online event to replace the physical on-site meetings. I very much look upon the EAU20 meeting. We are now pleased to announce the EAU20 Virtual Congress as a pilot, but I am sure that you will Virtual Congress, to be held on Friday, 17 July through find this innovative and informative. It is not our to Sunday, 19 July. The three full days of the Virtual intention to replace the ‘regular’ Annual EAU European Congress will be followed by the EAU20 Theme Week: Congress, as these in-person events have unique Association presenting the best abstracts from a variety of topics in qualities that are difficult to reproduce in an online of Urology an interactive and moderated setting in the evenings setting. At present we are continuing to make Guidelines of 20-26 July. This will be accessible to EAU20 arrangements for our next Annual Congress in Milan, 2020 edition participants and additionally to all EAU members. while keeping a close watch over future regulations related to the pandemic.

EAU Guidelines 2020

Now available online

Adapting to new realities It goes without saying that cancellation of the congress has had a major impact on the Association, and I would like to acknowledge the huge effort that has gone into dealing with the crisis by our Central Office. Inevitably, the difficulties are compounded by the necessity for everybody to work from home. But I March/May 2020

EAU members can order a printed copy free of charge (postage costs will apply) by contacting: eaureception@uroweb.org

European Urology Today

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Prof. José Maria Gil-Vernet Great role model, recognised by his contemporaries for his groundbreaking achievements

1922-2020 Professor José Maria Gil-Vernet passed away on March 5, 2020, in Barcelona, at the age of 97. Born in 1922, he once said that he had not been a good student in the difficult years of hardship that followed the Spanish civil war of 1936-1939, and the financial and political isolation of Spain from the European reconstruction after the end of the Second World War. But he succeeded in studying medicine in Barcelona and graduating in 1947. He presented his PhD thesis in Madrid in 1951 and returned to Barcelona, where he was greatly influenced by his father, the anatomist and urologist Salvador Gil Vernet. In the 1950s his father had made one of the most important modern contributions to the knowledge of the anatomy, pathology and function of the lower urinary tract and the prostate. Terence Millin referred to him as Vernet in his 1945 Lancet paper presenting the first results of retropubic prostatic enucleation, which improved on earlier approaches to the removal of prostatic hyperplasia.

European Urology Today Editor-in-Chief Prof. M. Wirth, Dresden (DE) Section Editors Prof. T.E. Bjerklund Johansen, Oslo (NO) Mr. Ph. Cornford, Liverpool (GB) Prof. O. Hakenberg, Rostock (DE) Dr. D. Karsza, Budapest (HU) Prof. P. Meria, Paris (FR) Dr. G. Ploussard, Toulouse (FR) Prof. J. Rassweiler, Heilbronn (DE) Prof. O. Reich, Munich (DE) Dr. F. Sanguedolce, Barcelona (ES) Prof. S. Tekgül, Ankara (TR)

This presented him with many legal problems, since it was a time when dialysis was still in its infancy, and organ transplantation raised numerous ethical, religious and legal questions that had to be resolved in the following years. He was a strong supporter of producing scientific films to teaching and training other surgeons, that later could reproduce a precise surgical technique. Luckily, numerous surgical documents of the time can be seen in the collection available online (see http://videosgilvernet.org/), kept by his son Dr. José M. Gil-Vernet Sedó, who has also takes care to preserve his grandfather’s surprising anatomical, anatomical-pathological, functional legacy and illustrations of the lower urinary tract (see: www.salvadorgilvernet.com/). Blandy, who claimed that he had not seen anyone performing surgery for complex lithiasis as Gil-Vernet did at a meeting in London.

In the late 1980s, urological surgery went through extraordinary developments, with the rise of Stone surgery endoscopic surgery for ureter stones and Since the mid-1950s, José Maria Gil-Vernet led the percutaneous surgery for kidney stones. Almost group of urologists attached to the Hospital Clinic simultaneously, extracorporeal shock wave lithotripsy in Barcelona, and since 1973 he directed the showed its possibilities (first lithotripsy center urology training school that his father had started, launched in Munich in 1982, first cases treated in mentoring numerous disciples who later practiced Spain, in Barcelona in 1984). Together, these new urology in Spain and Latin America, mainly. His techniques, completely relegated the indications for ten international courses of urology with surgical open surgery of urinary stones to unusual cases. operations, kidney transplant courses, and the reception of clinical visitors, were very popular Gil-Vernet also published on the radical treatment of among urologists around the world in 1987. (Fig.1) bladder cancer and urinary diversion with use the of the intestine (ileocecal segment), at a time when Urinary stones, urinary tuberculosis and cystectomy was still a major intervention, and simple neoplasms where by then the more prevalent uretero-sigmoidostomy was a frequent urinary genito-urinary diseases. The experience and diversion. He was also one of the first to use the small intestine to replace the injured ureter. inventiveness of José Maria Gil-Vernet in surgery for coraliform renal lithiasis stood out, in this Transplants arena he promoted the delicate dissection of the renal pelvis, renal sinus, and renal calyces, with After animal studies made in the operating rooms of their subsequent reconstruction, exhausting all the Barcelona Zoo, done without official aid, with the possibilities of leaving the kidney stone-free sole aim of improving the fate of patients with kidney failure who had a short life expectancy, Gil-Vernet and (sinus approach to renal stones). At that time, it was not so easy to check the stone position his kidney transplant team successfully did for the first time in Spain, in July 1965, a cadaveric donor kidney intraoperatively, and Gil-Vernet made recommendations for an optimal radiological transplant, in which the recipient's upper urinary tract exploration of the stone-bearing kidney, exposed was completely preserved, with a pyelopielic in a lumbotomy. His contribution to the progress anastomosis to the pelvis of the donor kidney. (Fig.2) of the surgery was recognised as extraordinary by (The first successful transplant between twins had been performed in Boston in 1954.) influential surgeons of his time such as John

José Maria Gil-Vernet remained in the urology service of the Hospital Clínico de Barcelona until 1987, and his last surgery course took place in 1987. He then retired, although he continued to attend a selected clientele at the Sant Josep Clinic in Barcelona, which disappeared in 2003. A life of achievement In my formative years, when social networks did not yet exist and it was not so easy to choose role models, I found that José Maria Gil-Vernet was the only Spanish urologist, living or dead, who appeared in the Encyclopedia Britannica, at the time a source of general information such as Wikipedia is today. Gil-Vernet recognised that he was not a good communicator, his interviews are few, and he maintained great discretion during his active life, both about his achievements and the attention to the prominent characters he attended to. Fortunately, he was recognised by his contemporaries and disciples. (Fig.3) Among the many awards with which he was recognised in recent years, it is worth highlighting the distinctions of the EAU Innovators in Urology Award in 2016, the Distinguished Career Award of the Société Internationale d'Urologie in 2009, and the Francisco Díaz medal of the Asociación Española de Urologia in 2002. Luis A. Fariña-Pérez Povisa Hospital, Vigo (ES) EAU History Office

Special Guest Editor Mr. J. Catto, Sheffield (GB) Founding Editor Prof. F. Debruyne, Nijmegen (NL) Editorial Team E. De Groot-Rivera, Arnhem (NL) L. Keizer, Arnhem (NL) H. Lurvink, Arnhem (NL) J. Seesing, Arnhem (NL) EUT Editorial Office PO Box 30016 6803 AA Arnhem The Netherlands T +31 (0)26 389 0680 F +31 (0)26 389 0674 EUT@uroweb.org

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Pictures and illustrations courtesy of Dr. José Maria Gil-Vernet Sedó Fig. 1: José Maria Gil-Vernet (left) in the surgical theater; Fig. 2: Gil-Vernet's first transplant technique (1965): pyelo-pielic anastomosis (the recipient's ureter would preserve its vascularity); anastomoses of the renal vein to the cava and the renal artery to the internal iliac artery; Fig. 3: José Maria Gil-Vernet and Prof. Willy Grégoire from Brussels (Secretary-General of the EAU 1972-1984), visiting Prof. Nikolay A. Lopatkin (1924-2013) in Moscow

Disclaimer No part of European Urology Today (EUT) may be reproduced without written permission from the Communication Office of the European Association of Urology (EAU). The comments of the reviewers are their own and not necessarily endorsed by the EAU or the Editorial Board. The EAU does not accept liability for the consequences of inaccurate statements or data. Despite of utmost care the EAU and their Communication Office cannot accept responsibility for errors or omissions.

Make sure we have your up-to-date address details! Log in to your My-EAU account on uroweb.org to update your e-mail and correspondence addresses. www.uroweb.org/My-EAU

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European Urology Today

Any comments or suggestions on articles in EUT are welcomed at: EUT@uroweb.org

March/May 2020


Update from the EAU Guidelines Office Guidelines Office Rapid Reaction Group (GORRG) We face a truly unprecedented healthcare crisis. The COVID-19 pandemic is testing the resources and capacity of health systems around the world. Anaesthetists and theatre teams are being redeployed, Intensive Care Units are struggling with a surge in demand for beds and our normal working patterns are being radically altered. In addition to this, frontline staff are being put under extreme pressure as colleagues are removed from the workforce due to “at risk” characteristics, or are themselves become exposed to the virus and are going into self-isolation. As a result, we are all being forced to reconsider the appropriate cause of action for patients dealing with urological issues. This brings into question if the latest guidelines based upon the best evidence and published only a few weeks ago are relevant in this crisis. In response to the COVID-19 pandemic, the Guidelines Office has been working in co-operation with the Executive Committee, the Section Offices and others to set up a Rapid Reaction Group (GORRG). Composed of highly-experienced and respected Board and Panel members, GORRG aims to provide rapid guidance, underpinned by the best knowledge available, on adapting EAU Guidelines recommendations to the current situation. All recommendations in the Guidelines have therefore been re-examined in-line with national and local COVID-19 guidelines and, where appropriate, adapted to the current situation. New evidence has been searched for by screening the available databases in a non-systematic procedure; recently accepted evidence has been included even when not released yet by the publisher. Each new recommendation has seen rapid peer-review. The revised recommendations cover the following areas: • Diagnosis • Surgical treatment • Follow-up In each addition each recommendation has been prioritised in the following manner: • LOW PRIORITY: Clinical harm (progression, metastasis, loss of function) very unlikely if postponed 6 months (GREEN COLOUR). • INTERMEDIATE PRIORITY: Cancel but reconsider in case of increase in capacity (not recommended postponing more than 3 moths: Clinical harm (progression, metastasis, loss of organ function) possible if postponed 3-4 months but unlikely) (YELLOW COLOUR). • HIGH PRIORITY: The last to cancel, prevent delay of > 6 weeks. Clinical harm (progression, metastasis, loss of organ function and deaths very likely if postponed > 6 weeks (RED COLOUR). • EMERGENCY: Cannot be postponed for more 24 hours. Life threatening situation (BLACK COLOUR). The Group are very mindful of significant differences between countries and regions, and depending on resources, doctors will need to make the decision to de-escalate from a high to a lower priority or vice versa. It should be understood there might not be high quality evidence for the compromises proposed, but it is anticipated the new information will function as an additional guide to the management of urological conditions during the current COVID-19 (coronavirus disease 2019) pandemic, based on the current EAU Guidelines. The revised guidelines are now been completed and can be found on the EAU website at: www.uroweb. org/guideline/covid-19-recommendations/. An article has also been submitted to European Urology giving further background and information on the revised guidelines. Guidelines Publications and app As the March EAU Annual Congress in Amsterdam was postponed initially, now to be replaced by a virtual meeting from 17 to 19 July, the full text and pocket versions of the 2020 European Association of Urology Guidelines were launched online on 25th March on the EAU website. The PDFs of the documents and other accompanying materials were also made available for members to download. Due to the exceptional circumstances, this year all the Guidelines Office

March/May 2020

PDFs of the EAU Guidelines can be accessed also by non-EAU members as from 25th June. In addition, the pocket version as an app for iOS and android devices was launched on 6 April 2020. Full members will receive a copy of the pocket guidelines in the mail, as standard (together with the 2020 edition of the Historia Urologiae Europaeae book). A copy of the extended guidelines in a printed format can be posted on request free of charge (postage costs will apply) for full EAU members by contacting: eaureception@uroweb.org If multiple copies are ordered, there is a reduced fee for the second, and then subsequent copies.

New Working Group on Non-neurogenic Female LUTS We are delighted to announce the formation of a new working group to address the EAU Guidelines on Non-neurogenic Female LUTS. The panel is chaired by Prof. Chris Harding (GB) and the vice-chairman is Prof. Mela Lapitan (PH). Aside from all aspects of female urinary incontinence, the new Panel also aim to address underactive bladder, nocturnal polyuria and expand on urinary fistula. The panel met for the first time earlier in the year to discuss the processes involved in producing new guidelines and the priorities for the coming years. A number of systematic reviews are now being set up to underpin the new Guidelines at EAU2021.

European Association of Urology

Strange and unprecedented times in our history. . . . . . . . . . . . . . . . . . . . . . . . . 1

Guidelines

Obituary Prof. José Maria Gil-Vernet. . . . . . . . 2

2020 edition

Update from the EAU Guidelines Office. . . . . . 3 ESUO redefines its name and mission. . . . . . . 4 Prof. Chris Harding (GB)

Prof. Mela Lapitan (PH)

ESFFU: Botulinum toxin A bladder injections. . 6 Clinical challenge. . . . . . . . . . . . . . . . . . . . . . 7 Key articles from international medical journals. . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11

Recent publications from Panels We are very pleased to announce that several papers from Guidelines Panels have recently been accepted for publication: • Limitations of Available Studies Prevent Reliable Comparison Between Tumour Ablation and Partial Nephrectomy for Patients with Localised Renal Masses: A Systematic Review from the European Association of Urology Renal Cell Cancer Guideline Panel. Abu-Ghanem, Y, et al. Eur Urol Oncol. 2020 Mar 31. pii: S2588-9311(20)30026-2. [Epub ahead of print] • European Association of Urology Guidelines Office: How We Ensure Transparent Conflict of Interest Disclosure and Management. Smith, E.J, et al. Eur Urol. 2020 Apr;77(4):397-399. Epub 2020 Jan 25.

• Benefits and Risks of Primary Treatments for High-risk Localized and Locally Advanced Prostate Cancer: An International Multidisciplinary Systematic Review. Moris, L, et al. Eur Urol. 2020 May;77(5):614-627. • Biochemical Recurrence in Prostate Cancer: The European Association of Urology Prostate Cancer Guidelines Panel Recommendations. Van den Broeck, T, et al. Eur Urol Focus. 2020 Mar 15;6(2):231-234.

EAU RF supports a new registry infrastructure. . . . . . . . . . . . . . . . . . . . . . . . 12 PIONEER: Prostate Cancer Big Data For Better Outcomes Project Over the course of the last six months, the primary focus of PIONEER has been on negotiations with possible data contributors (WP3). PIONEER has now begun to sign data sharing agreements with data contributors and to populate its single harmonised data platform (WP4). In an important step forward, the first datasets have been transferred into the PIONEER platform by Erasmus University Medical Centre (MC). Erasmus MC have uploaded two of the most well-known European datasets: 1. The Prostate Cancer Research International Active Surveillance (PRIAS) study, which was initiated in 2006 and has developed into the largest active surveillance study worldwide, with more than 8000 patients from 120 centres in 18 countries. 2. The European Randomised study of Screening for Prostate Cancer (ERSPC) Rotterdam. ERSPC was initiated in 1993 and is the largest ever randomised study on screening for prostate cancer, involving 184,000 men in eight countries. The Netherlands patient cohort from Erasmus MC contains more than 42,000 patients. The aim of ERSPC is to investigate the effect of regular prostate-specific antigen (PSA) screening on prostate cancer mortality. Lund University have contributed two comprehensive Swedish datasets. The Malmö Preventative Project, a 16 year screening study in the middle-aged population of Malmö including 22,444 men, and the Malmö Diet Cancer dataset: an ongoing prospective cohort study including 53,000 participants of which 42% are male. The aim of this study is to clarify whether diet is associated with certain forms of cancer whilst taking other life-style factors into account. The Lund datasets will be the next to be uploaded to the PIONEER platform. In addition, the first Data Sharing Agreement has been signed with external data contributor Active Biotech AB. Active Biotech AB has now shared data collected in a phase 3 randomised, doubleblind, placebo-controlled study of tasquinimod in men with metastatic castrate-resistant prostate cancer. The data from 411 men was collected between 2011 and 2015 and has been shared to the PIONEER platform using the central data-sharing model. These harmonised datasets will be used to begin to answer PIONEER’s prioritised research questions.

• What Is the Most Effective Treatment for Nocturia or Nocturnal Incontinence in Adult Women? Bedretdinova, D, et al. Eur Urol Focus. 2020 Feb 12. pii: S2405-4569(20)30030-4. [Epub ahead of print] Review.

All publishable PIONEER deliverables and report summaries can be viewed in the resource section of the PIONEER website (www.prostate-pioneer.eu). Follow PIONEER on Twitter @ProstatePioneer for the latest project developments.

Changing the future of bladder cancer variants . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 EAU RF studies on devices, instruments, disposables, etc.. . . . . . . . . . . . . . . . . . . . 13-14 Obituary Viorel Bucuras. . . . . . . . . . . . . . . . 14 Introducing European Urology Open Science. . 15 Historical highlights from urology in the Netherlands. . . . . . . . . . . . . . . . . . . . . . 16 ESU section: ESU-ESUT Masterclass on Urolithiasis goes virtual . . . . . . . . . . . . . . . . . . . . . . . . . 17 ESU-ESUI Masterclass on Prostate Biopsy. . . 18 Let’s get digital: e-courses, webinars and Edu platforms . . . . . . . . . . . . . . . . . . . . 19 ESU-ESOU masterclass: "Inspiring, engaging and familial". . . . . . . . . . . . . . . . . 20 ESU course delivers crucial PCa & BCa updates in Rabat . . . . . . . . . . . . . . . . . . . . . 21 YUO section: A chance of 1 out of 50,000 . . . . . . . . . . . . . 22 Iberic Resident Play: Webinars enlighten challenging topics . . . . . . . . . . . . . . . . . . . . 23 ESOU redesigns strategies, launches ESOU Online . . . . . . . . . . . . . . . . . 24 EULIS: A response to limited scientific progress in urolithiasis. . . . . . . . . . . . . . . . . 24 ESOU20 unveils contemporary GU updates. . . . . . . . . . . . . . . . . . . . . . . . . . 25 ESUP: Examination with the wholemount section technique . . . . . . . . . . . . . . . 26 Using a flexible ureteroscope for more than 500 procedures . . . . . . . . . . . . . . . . . . 27 “EU must do more on prostate cancer”. . . . 28 The politics of clinical trials . . . . . . . . . . . . . 29 COVID-19 postpones changes in rules on medical devices. . . . . . . . . . . . . . . . . . . . 29 Patient information: Animated videos An embedded tool in patient information. . . 33 EAUN section: The quality and use of communication in PCa decision aids. . . . . . . . . . . . . . . . . . . 35 Rare and unknown: Sleep-related painful erections . . . . . . . . . . . . . . . . . . . . . 36

European Urology Today

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ESUO redefines its name and mission EAU Section of Outpatient and Office Urology hopes to increase appeal By Loek Keizer The EAU’s youngest section, the ESUO has changed its name to better reflect the realities of outpatient urology around Europe. Founded in 2017 as the EAU Section of Urologists in Office, it has spent the last three years getting insights into how office urologists work across the continent and come to several conclusions that have impacted its mission and, indeed, name.

questionnaires through the EAU’s channels. The results, as published online and in previous editions of European Urology Today reveal a great scale and also diversity of the field.

Haas: “From our questionnaires we learned a lot about which methods in diagnostics and treatment that office and outpatient urologists use in each country and, beyond that, in which institution (office, medical centre, hospital) and in which kind of employment (self-employed, employed, The ESUO will retain its acronym but from now on will combination) they’re working. The general be known as the EAU Section of Outpatient and Office impression? There is a great variety and no general Urology. This change was requested by its chairman, rule. Each country has developed its own way to Prof. Helmut Haas (Heppenheim, DE) and recently treat outpatients.” approved by the Section Office and EAU Board. In “When starting our section we were convinced that changing its name and redefining its mission, the ESUO hopes to appeal to a wider range of outpatient- ‘self-employment’ and ‘own office’ were core characteristics of the group of urologists that we treating urologists and help these professionals in intended to care for, and we had designated them as their duties. ‘office urologists’. From our section members we “When we started our section, we didn’t have a clear know that many of them are not working under these conditions. Colleagues from other countries (e.g. view of in-office and outpatient urology in Europe,” said Prof. Haas. “It was a somewhat neglected part of Spain) tell us that they strictly refuse the designation urology and we had to explore the exact nature of the ‘office urologist’ (“I work in my own clinic!”) and don’t want to identify themselves with our section even field as a first step.” though their everyday work is the same as ours.” “When we started, we were aware of an EBU study by Kiely et al. from 2000, which was updated in 2007. Redefining the ESUO This realisation led the ESUO to a new definition for They’d counted about 4000 office urologists in itself as a section and its target audience. The newly Europe. Based on this information we initially christened EAU Section of Outpatient and Office estimated a current number of office urologists of Urology now seeks to represent European urologists: about 6000. Exploring the situation, we have since found out that they number more than 10,000, • Who treat outpatients as their main profession, in especially due to the great numbers in Russia and more than 50% of their working hours Germany. There are still several countries that we are • Within the context of an established professional interested in hearing from. (Fig. 1) profile, not only temporarily • Independently of how they are employed, and Mapping out office urology whether they do it in an office, medical centre or The ESUO set out to get a better idea of the state of hospital. office urology in Europe by sending out EAU Section for Urologists in Office (ESUO)

Haas hopes and expects that this redefinition section members who work under these conditions feel more

comfortable in the ESUO, and that colleagues from other countries will be attracted if we renounce our old definition. “Our section will be better able to unite outpatient urologists from more (if possible: all) European countries under the umbrella of the EAU.” The ESUO within the EAU The change in name also comes at a point at which the Section and its chairman can reflect on a successful three years under the EAU. “We were impressed by the cordial welcome, the friendship and support by Fig. 1: Countries the ESUO has data on in green the EAU Executives and the ‘family’ of the EAU offices,” said Haas. sections. We received all support that we asked for from the EAU. We are very grateful to the other “This is all the more appreciated because the EAU’s sections and the EAU board.” other sections represent a special subject or subspecialty in urology from an academic and clinical Prof. Haas is pleased with the progress that the point of view. Our section on the other hand aims to ESUO has made since its inception. “We started out unite a special professional group in Europe: the with three section members. Now our section has 27 outpatient and office urologists who often treat their members from 17 countries. A core group of about patients outside hospital.” 12 members is very active, giving presentations and organising meetings on the topic. We gave ourselves “Our patients are those with a minor degree of the task of getting in contact with national disease who don’t need clinical treatment but do associations and to start a collaboration of require a more specialised treatment than a general outpatient urologists. As a result, we received practitioner can offer. We have to be able to provide invitations from several national associations to give these patients with up-to-date specialist care not only speeches or organise special sessions during their in big cities but in the breadth of the country and near congresses.” to their home.” “Since 2018, the number of invitations has been “This different perspective can lead to increasing every year. We look forward to hearing misunderstandings between clinicians and outpatient from our colleagues and societies from across urologists. But to the EAU’s credit, we don’t feel a gap Europe and I encourage them to reach us at: between our section and the other specialised esuo@uroweb.org”.

Programme Monday, 20 July

Andrology

Tuesday, 21 July

Imaging

Wednesday, 22 July

Functional Urology

Thursday, 23 July

Bladder Cancer

Friday, 24 July

Renal Cancer

Saturday, 25 July

Prostate Cancer

Sunday, 26 July

Stones

Join us during the EAU20 Theme Week www.eau20.org 4

European Urology Today

March/May 2020


VIRTUAL 17-19 July

#EAU20

Cutting-edge Science at Europe’s largest Urology Congress

EAU20 Virtual Programme Friday, 17 July 08:20 - 08:30 Introduction Welcome to the EAU20 Virtual Congress 08:30 - 09:10 Game Changing session 1 08:30 - 08:50 Continence following robot-assisted (R-LRPE) and conventional laparoscopic radical prostatectomy (LRPE) - results of a prospective, randomized, multicenter, patient blinded study 08:50 - 09:10 ProPSMA Study: A prospective randomised multi-centre study of PSMA-PET/CT imaging for staging high risk prostate cancer prior to curative-intent surgery or radiotherapy 09:10 - 11:40

Plenary session 01 Modern prostate cancer imaging in daily practice 09:10 - 09:20 Ultrasound in prostate cancer imaging: Dead or ready to get started? 09:20 - 10:10 Prostate biopsies 10:10 - 10:20 Screening strategy and active surveillance in 2020 10:20 - 10:45 Biochemical recurrence I 10:45 - 11:20 Biochemical recurrence II 11:20 - 11:30 A peek into the future: Artificial intelligence and prostate cancer imaging 11:30 - 11:40 Discussion, questions and answers 11:40 - 13:00

11:40 - 11:45 11:45 - 12:25 12:25 - 12:45 12:45 - 13:00 13:00 - 14:30

Thematic session 01 Focal therapy for prostate cancer: Mid-term oncological outcomes and salvage radical prostatectomy Introduction to Focal Therapy Midterm oncological results of focal therapy Outcomes of salvage radical prostatectomy after focal therapy Discussion, questions and answers

14:25 - 14:30

Plenary Session 02 New frontiers in infections View on the Coronavirus crisis from a European perspective New diagnostic techniques to overcome antibiotic resistance How to minimise infectious complications of prostate biopsies: A white paper Urosepsis: Hot data from the SERPENS study Infection control practices in patients at risk for multiresistant pathogens Discussion, questions and answers

14:30 - 15:30

Industry Session 1

15:30 - 17:00

Thematic session 02 Men’s health 2020 The urologist as a gatekeeper for men’s health Case-based debate Preservation of quality of life in prostatic disease Discussion, questions and answers

13:00 - 13:15 13:15 - 13:30 13:30 - 13:50

13:50 - 14:05 14:05 - 14:25

15:30 - 16:00 16:00 - 16:55

16:55 - 17:00 17:00 - 18:30

17:00 - 17:15 17:15 - 17:30

Thematic session 03 Management of patients with CRPC in 2020 CRPC: Prediction of response to systemic treatment Imaging of CRPC - what is possible, what is necessary?

March/May 2020

Visit www.eau20.org/scientific-programme/ for the latest updates

Molecular pathology before systemic treatment - what is feasible? Case-based debate M0 CRPC: Androgen Receptor Targeted Treatment (ARTA) The best sequence for M+ CRPC in 2020 Discussion, questions and answers

13:15 - 15:00

18:30 - 20:00 Thematic session 04 Radioligand therapy in metastatic castration-resistant prostate cancer 18:30 - 18:45 Current and future radioligands (ligands and emitters) 18:45 - 19:00 Limitations of PSMA based on prostate cancer biology 19:00 - 19:15 Critical assessment of radioligand therapy 19:15 - 19:50 Case-based debate (PSMA)-targeted radioligand therapy: For which patients, which stages? 19:50 - 20:00 Discussion, questions and answers

13:50 - 14:15

Saturday, 18 July

16:30 - 17:00

Best abstract session: Non-oncology

08:30 - 09:05 Game Changing session 2 08:30 - 08:45 Recurrence Risk in patients with High Grade Non-Muscle Invasive Bladder Carcinoma in the Randomised Phase III Clinical Trial ‘NIMBUS’ stratified for EORTC and CUETO risk categories. A contemporary trend to less recurrences? 08:45 - 09:00 Results from the phase III study of nadofaregene firadenovec: Safety and efficacy in patients (pts) with high-grade, BCG-unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) 09:00 - 09:05 Discussion, questions and answers

17:00 - 18:10

Thematic session 07 Immunotherapy and beyond Perioperative therapy for urothelial cancer Should we sequence all urothelial cancer patients? Immunotherapy combinations for intermediate-poor risk mRCC Novel urothelial cancer treatment beyond PD-1/PD-L1 inhibition Discussion, questions and answers

17:30 - 17:45

17:45 - 18:10

18:10 - 18:20 18:20 - 18:30

09:05 - 11:25

Plenary session 03 Challenges across the spectrum of bladder cancer 09:05 - 09:15 Definition of very high-risk and refractory NMIBC 09:15 - 09:45 Early cystectomy in high-risk NMIBC: A standard? 09:45 - 10:00 Immunotherapy and beyond: New options for NMIBC 10:00 - 10:15 Urinary markers in low-grade NMIBC: Ready to stop cystoscopies? 10:15 - 10:30 Frailty and cognitive assessment in patients diagnosed with MIBC 10:30 - 10:45 Treatment options for elderly patients with muscle-invasive bladder cancer 10:45 - 11:00 Different Bladder Cancer Genotypes: New treatment options 11:00 - 11:15 The future of personalised treatment: Test the tumour for a response 11:15 - 11:25 Discussion, questions and answers 11:25 - 13:00

11:25 - 11:55 11:55 - 12:25 12:25 - 12:55 12:55 - 13:00 13:00 - 13:15 13:00 - 13:10

13:10 - 13:15

Thematic session 05 Five things I wish I would have known earlier in my career: Lessons from the mentors Bladder Cancer Kidney Cancer Prostate Cancer Discussion, questions and answers Game changing session 3 The real effect of prostate cancer treatment: EUPROMS study first patient driven quality of life study ever Discussion, questions and answers

13:15 - 13:25

13:25 - 13:50

14:15 - 14:25

14:25 - 15:00

Plenary session 04 Bladder dysfunction, storage symptoms and benign prostatic disease Basic neurological workup in a male LUTS patient: Key points for daily clinical practice Non-neurogenic OAB in a 60yr man with 60g prostate: First-line medical prescription Non-neurogenic OAB and proven obstruction, drugs don’t work Persistence of OAB symptoms after prostate surgery, despite good de-obstruction Minimally-invasive options for day case surgery

11:35 - 13:00 11:35 - 11:50 11:50 - 12:05 12:05 - 12:20 12:20 - 12:35 12:35 - 12:50 12:50 - 13:00 13:00 - 15:10 13:00 - 13:10 13:10 - 13:45

15:00 - 16:00 Industry Session 2 16:00 - 16:30 Thematic session 06 Urinary reconstruction in (neuro) urology 16:00 - 16:30 Debate: What happens if Botox does not work in MS anymore?

13:45 - 13:55 13:55 - 14:15

14:15 - 14:50

17:00 - 17:20 17:20 - 17:30 17:30 - 17:50 17:50 - 18:00 18:00 - 18:10 18:10 - 19:40 18:10 - 18:25 18:25 - 19:00 19:00 - 19:25 19:25 - 19:40

Thematic session 08 Salvage LND prostate cancer Does early diagnosis help the patient? Primary treatment of pelvic lymph node metastatic prostate cancer Treatment of recurrent lymph node metastatic PCa Treatment of polymetastatic hormone sensitive prostate cancer

14:50 - 15:10

Industry Session 3

16:10 - 17:00

Thematic session 10 New technology for urology Patterns and computers Small devices, new materials Discussion, questions and answers

16:10 - 16:30 16:30 - 16:55 16:55 - 17:00 17:00 - 19:00

17:00 - 17:10

17:10 - 17:25

17:25 - 17:35 17:35 - 17:50

08:30 - 09:05 Game changing session 4 08:30 - 08:45 A prospective randomized study of bicalutamide +/- docetaxel for non metastatic prostate cancer with a rising PSA (SPCG-14) 08:45 - 09:00 Health-related quality-of-life (HRQoL) analysis from KEYNOTE-426: pembrolizumab (pembro) plus axitinib (axi) vs sunitinib for advanced renal cell carcinoma (RCC) 09:00 - 09:05 Discussion, questions and answers 09:05 - 11:35

Plenary session 05 Nightmare on robotics 09:05 - 09:50 Mechanical failure of the robot during RARP: Should I have stopped? 09:50 - 10:35 Were you ready for this level of complexity? Robotic T3 RCC into the IVC 10:35 - 11:20 Was your team appropriately skilled? Bowel perforation during robotic radical cystectomy 11:20 - 11:35 Discussion, questions and answers

Plenary session 06 Stones: The role of innovation Temperature and intrarenal pressure during laser lithotripsy Round-table discussion Perioperative Antibiotic Prophylaxis: When, how and how long? How to minimise radiation exposure in endourology New technology in retrograde intrarenal surgery: Unnecessary luxury vs. measurable benefit Round-table discussion Beyond holmium laser: New lithotripsy devices Round-table discussion 1cm stone in the lower calyx plus 2cm upper ureteral stone with complete obstruction

15:10 - 16:10

19:40 - 20:00 Best abstract session: Oncology

Sunday, 19 July

Thematic session 09 Complications of renal surgery Complications of laparoscopic renal surgery Complications of robotic renal surgery Complications of retrograde intra-renal surgery Complications of renal transplantation Complications of open renal surgery Discussion, questions and answers

17:50 - 18:00 18:00 - 18:15 18:15 - 18:45

18:45 - 19:00

Plenary session 07 #Testis cancer and surgical andrology The current treatment algorythm for Peyronie’s disease: Is there still a role for surgery? “I wish I’d never…”: Complications and how to avoid them in male genital reconstructions Infertility and the risk of testis cancer: New molecular connections Autologous testicular tissue transplantation in young cancer patients: How far are we? How to manage testicular microlithiasis and CIS The new testis cancer biomarker miRNA 371: Ready for prime time? Twitter told me the robot can do it: Small retroperitoneal masses in testis cancer, what is best? Stage IIA Discussion, questions and answers

19:00 - 20:00 Thematic session 11 Controversies in renal cancer surgery 19:00 - 19:20 Case based debate Organ preservation: Do the benefits outweigh additional risks? 19:20 - 19:30 Open vs. minimally invasive partial nephrectomy: What is the evidence? 19:30 - 19:40 How to best approach the large renal mass: Tips and tricks 19:40 - 20:00 Case based debate Cytoreductive nephrectomy: What do we know?

European Urology Today

5


Botulinum toxin A bladder injections An update, eight years after authorities’ licence Ms. Mehwash Nadeem Fellow in Female, Functional and Restorative Urology UCLH London (UK) drmehwash7@ gmail.com

Mr. Rizwan Hamid UCLH & London Spinal Injuries Unit London (UK)

hamid_rizwan@ hotmail.com The use of intradetrusor botulinum toxin A (BTX-A) has revolutionised the treatment algorithm for patients with symptoms of overactive bladder (OAB). BTX-A is a neurotoxin produced by Clostridium botulinum that was first described in 1895 by Emile van Ermengem1. It has been in clinical use for the treatment of neurogenic detrusor overactivity (NDO) since 1999. It was approved by the US Food and Drug Administration (FDA) for this indication in 2011. In 2012, it was approved in Europe and in the US in January 2013 for the treatment of OAB symptoms2,3. There are seven serotypes of BTX (A–G), with BTX-A being the most common to treat lower urinary tract symptoms. The dose, efficacy, and safety profiles are different for each as all contain different fragments of the protein, hence dose conversion is not recommended. The two most studied preparations are onabotulinumtoxinA (Botox™, Allergan, Inc., Irvine, CA, USA) and abobotulinumtoxinA (Dysport®, Ipsen Biopharm Ltd, Slough, UK)4. To date, the only FDA-approved agent for treatment of OAB symptoms is Botox™.

"Several studies were undertaken comparing doses of 100 U, 150 U and 200 U for OAB symptoms. The lower dose provides comparable results with relatively low complication rates, especially a lower incidence of urinary retention6." Dose In 2013, the FDA approved a dose of 100 units of BTX-A for OAB symptoms3 with an overall dose not exceeding a total dose of 360 units in a three-month interval5 for all indications. Several studies were undertaken comparing doses of 100 U, 150 U and 200 U for OAB symptoms. The lower dose provides comparable results with relatively low complication rates, especially a lower incidence of urinary retention6. In 2017, the total maximum safe dose was revised upwards to 400 units7. Technique Most of the studies used trigone sparing technique to avoid potential complication of vesicoureteral reflux. However, two RCTs by Manecksha et al. and Kuo et al. showed that trigonal injection is safe and effective8,9. The most recent RCT by Chen and co-workers has confirmed this finding10. A metaanalysis published in 2015, however, did not show any difference in the outcome when comparing these two techniques11. Several studies have compared intradetrusor injection to submucosal injections. Most showed comparable results9,12. The widely accepted approach remains predominantly intradetrusor trigone sparing injection.

The adverse events (AEs) of intradetrusor BTX-A are mainly localised in the urinary tract including urinary tract infections (14%), visible haematuria (8%), large post-void residual volume (> 150 ml, 47%) and urinary retention (8%). However, a real-life study has demonstrated that the rate of patients reporting urinary tract infection is 1% and that of retention is 0.4%13. The risk factors for increasing incidence of AEs have been identified as male gender, baseline PVR ≥ 100 ml, comorbidity, and BTX-A dose > 100 U14. Although muscle weakness or hyposthenia has been reported after the injection, it is reassuring that a recent study has confirmed these events are rare and transient15.

"Repeat injections are safe and efficacious with duration of symptom relief reported from six to twelve months in various studies22." Adverse events Dawson et al. reported the most common reasons for discontinuing treatment were poor efficacy (13%) and the need for clean intermittent self-catheterisation (CISC)-related issues (11%). This study reported an incidence of 35% for CISC after the first injection16. Other studies, however, reported lower rate of CISC with 4%17 and 10.9%18. Not surprisingly, the rate of CSIC doubles with increase in dose from 100 U to 200 U. The variation in rate of CISC in different studies is likely due to different criteria of PVRs at which patients were instructed to perform CISC. Interestingly, the patient-reported incidence of CISC was 1% in the GRACE study, a phase IV study13. Sahai et al. looked at the urodynamics parameters to identify poor responders and showed a maximum detrusor pressure of > 110 cm of water on overactive contraction to be a predictor of failure19. BTX-A injections are safe for OAB in patients who are frail, have medical comorbidities (Parkinson’s disease, chronic cerebrovascular accident, dementia or diabetes), or a history of prior lower urinary tract surgery. However, these patients reported to have large PVRs and relatively low success rate20. Efficacy of BTX-A injection is maintained with repeat injections21 contrary to the concern about loss of efficacy due to immune response. Repeat injections are safe and efficacious with duration of symptom relief reported from six to twelve months in various studies22. Future perspective The clinical applications of BTX-A have been extended from NDO and OAB symptoms to the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS), benign prostatic hyperplasia, non-relaxing external sphincter and neurogenic or non-neurogenic lower urinary tract dysfunction in children. Currently, it is approved for NDO and OAB symptoms only, although there are ongoing trials in other conditions to expand the indications. Some show promising therapeutic effects15. Conclusion BTX-A has stood the test of time and has been used for over two decades to treat LUT dysfunction. It has

Safety and efficacy Large multicentre, placebo-controlled RCTs have reported improved quality of life and significant reduction in episodes of incontinence, with reported success rates of 62.8%2 and 60.8%3. EAU Section of Female and Functional Urology

6

European Urology Today

Intradetrusor Botulinum toxin A injection

KEY POINTS

• 100 U of BTX-A has been proved to be an effective dose • Predominant injections are intradetrusor and trigone sparing • No new/significant adverse events have been reported over the longer term • The main side effects are urinary tract infections and urinary retention real-life phase IV study (GRACE) demonstrates that the rate of side effects might • The be lower than reported in pivotal studies risk factors for increasing the incidence of AEs have been identified as male • The gender and large post-void residue main reasons for discontinuation are poor efficacy and need for self• The catheterisation

• The efficacy of BTX-A injections is maintained over repeated injections has stood the test of time and has been used for over two decades to treat • BTX-A LUT dysfunction been proved to be a safe and effective treatment option to control OAB symptoms with long-term studies confirming sustained benefits with a minimal side effect profile. There is ongoing research to expand the therapeutic indications to several indications, but now BTX-A is only licenced for treatment of NDO and OAB.

"There is ongoing research to expand the therapeutic indications to several indications, but now BTX-A is only licenced for treatment of NDO and OAB." References 1. Van Ermengem E. Classics in infectious diseases. A new anaerobic bacillus and its relation to botulism. Originally published as "Ueber einen neuen anaëroben Bacillus und seine Beziehungen zum Botulismus" in Zeitschrift für Hygiene und Infektionskrankheiten 26: 1-56, 1897. Rev Infect Dis. 1979 Jul-Aug; 1(4):701-19. 2. Chapple CR, Sievert KD, MacDiarmid S, et al. OnabotulinumtoxinA 100 U significantly improves all idiopathic overactive bladder symptoms and quality of life in patients with overactive bladder and urinary incontinence: a randomised, double-blind, placebocontrolled trial.Eur Urol. 2013 Aug;64:249-56 3. Nitti VW, Dmochowski R, Herschorn S, et al. EMBARK Study Group OnabotulinumtoxinA for the treatment of patients with overactive bladder and urinary incontinence: results of a phase 3, randomised, placebo controlled trial. J Urol. 2013;189:2186–2193 4. Chapple CR. Which preparation of botulinum toxin a should be used, where should it be injected, and how should its efficacy be assessed? Eur Urol. 2012;61(5):936– 937. discussion 938 5. https://www.accessdata.fda.gov/drugsatfda_docs/ label/2017/103000s5302lbl.pdf 6. Tincello D, Fowler CJ, Slack M. Botulinum toxin for overactive bladder, Scientific Impact paper no.42. https:// www.rcog.org.uk/globalassets/documents/guidelines/ scientific-impact-papers/sip_42.pdf 7. https://www.accessdata.fda.gov/drugsatfda_docs/ label/2013/103000s5251lbl.pdf 8. Manecksha RP, Cullen IM, Ahmad S, et al. Prospective randomised controlled trial comparing trigone-sparing

versus trigone-including intradetrusor injection of abobotulinumtoxin for refractory idiopathic detrusor overactivity. Eur Urol 2012;61:928-35. 9. Kuo, H.C. Bladder base/trigone injection is safe and as effective as bladder body injection of onabotulinumtoxinA for idiopathic detrusor overactivity refractory to antimuscarinics. Neurourol. Urodyn. 2011, 30, 1242–1248 10. Chen H, Xie K, Jiang C. A single blind randomised control trial of trigonal versus nontrigonal Botulinum toxin-A injections for patients with urinary incontinence and poor bladder compliance secondary to spinal cord injury. J Spinal Cord Med. 2020 Jan 31:1-8. 11. Davis NF, Burke JP, Redmond EJ, Elamin S, Brady CM, Flood HD. Trigonal versus extratrigonal botulinum toxin-A: A systematic review and meta-analysis of efficacy and adverse events. Int. Urogynecol. J. 2015, 26, 313–389. 12. Krhut J, Samal V, Nemec D, Zvara P. Intradetrusor versus suburothelial onabotulinumtoxinA injections for neurogenic detrusor overactivity: a pilot study. Spinal Cord. 2012 Dec;50(12):904-7. 13. Hamid R , Lorenzo-Gomez M-F, Schulte-Baukloh H , Boroujerdi A , Patel A, Farrelly E. A multinational real-world study of onabotulinumtoxinA in patients with overactive bladder demonstrates reduction in urinary symptoms and an improvement in quality of life along with a reduction in reliance on incontinence products. https://scientificprogramme. uroweb.org/eau19 14. Kuo HC, Liao CH, Chung SD. Adverse events of intravesical botulinum toxin a injections for idiopathic detrusor overactivity: Risk factors and influence on treatment outcome. Eur Urol. 2010 15. Chen JL, Kuo HC. Clinical application of intravesical botulinum toxin type A for overactive bladder and interstitial cystitis. Investig Clin Urol. 2020;61(Suppl 1):S33–S42. 16. Dowson C, Watkins J, Khan MS, Dasgupta P, Sahai A. Repeated botulinum toxin type A injections for refractory overactive bladder: medium-term outcomes, safety profile, and discontinuation rates. Eur Urol. 2012;61(4):834–839 17. Nitti VW, Ginsberg D, Sievert KD, Sussman D, Radomski S, Sand P, et al. Durable efficacy and safety of long-term OnabotulinumtoxinA treatment in patients with overactive bladder syndrome: final results of a 3.5year study. J Urol. 2016 18. Dmochowski R, Chapple C, Nitti VW, Chancellor M, Everaert K, Thompson C, et al. Efficacy and safety of onabotulinumtoxinA for idiopathic overactive bladder: a double-blind, placebo controlled, randomised, dose ranging trial. J Urol. 2010;184:2416–2422 19. Sahai A, Khan MS, Le Gall N, Dasgupta P, GKT Botulinum Study Group Urodynamic assessment of poor responders after botulinum toxin-A treatment for overactive bladder. Urology. 2008 20. Liao CH, Wang CC, Jiang YH. Intravesical OnabotulinumtoxinA Injection for Overactive Bladder Patients with Frailty, Medical Comorbidities or Prior Lower Urinary Tract Surgery. Toxins (Basel). 2016;8(4):91. Published 2016 Mar 25. 21. Kim SH, Habashy D, Pathan S, Tse V, Collins R, Chan L. Eight-Year Experience With Botulinum Toxin Type-A Injections for the Treatment of Nonneurogenic Overactive Bladder: Are Repeated Injections Worthwhile?. Int Neurourol J. 2016;20(1):40–46. 22. Cox L, Cameron AP. OnabotulinumtoxinA for the treatment of overactive bladder. Res Rep Urol. 2014;6:79–89. Published 2014 Jul 21. doi:10.2147/RRU. S43125

March/May 2020


Clinical challenge Prof. Oliver Hakenberg Section editor Rostock (DE)

Oliver.Hakenberg@ med.uni-rostock.de

The Clinical challenge section presents interesting or difficult clinical problems which in a subsequent issue of EUT will be discussed by experts from different European countries as to how they would manage the problem. Readers are encouraged to provide interesting and challenging cases for discussion at h.lurvink@uroweb.org

Case study No. 65 This 28-year-old man complains of poor urinary stream with a feeling of incomplete emptying since 6 months. He is a keen horse rider since the age of 14. There is no history of injury, infection or urethral catheterisation. The maximum urinary flow is 10 ml/ sec. Urethrography shows a bulbar urethral stricture.

Case study No. 64 A 60-year-old otherwise healthy lady presents with recurrent episodes of febrile urinary tract infections which led to the diagnosis of a left pelvic kidney with a large staghorn calculus (CT scan, fig.1-3). Discussion point: • What treatment is advisable? Figure 2

Case provided by Prof. Oliver Hakenberg, Dept. of Urology, University Hospital Rostock, Germany. email: oliver.hakenberg@med.uni-rostock.de

Figure 3

Discussion point • What are the options? Figure 1

Case provided by Dr. Amin Bouker, Clinique Taoufik, Tunis, Tunisia. E-mail: aminbouker@gmail.com

Best approach: Laparoscopy-assisted percutaneous nephrolithotomy combined with a flexible URS Comments by Dr. Yazeed Barghouthy and Prof. Olivier Traxer Paris (FR)

Dr. Yazeed Barghouthy

Prof. Olivier Traxer

Important considerations before treatment: kidney function and absence of UPJ obstruction as an accompanying pathology that might necessitate

treatment - both can be evaluated by a diuretic renogram. Another consideration is the relation to adjacent intestines and blood vessels, for which a p.o. contrast CT and later a tri-phasic CT should be done. After this evaluation has been accomplished, the options for the management of a staghorn stone in an ectopic kidney include: laparoscopy assisted percutaneous nephrolithotomy (combined with a flexible URS) or laparoscopic / robot-assisted laparoscopic pyelolithotomy. Shock-wave lithotripsy and flexible URS alone would not be suitable options in this case given the large volume of the stone and the probable need for multiple sessions to treat an infected stone by definition. While a pyelolithotomy alone would be suitable for a pelvic stone, it can be insufficient for a

staghorn stone with difficulty extracting the stone from the calyces. Hence pyelolithotomy alone might not be adequate. A retroperitoneal approach is an option for management of stones in pelvic kidneys with a laterally or anterior oriented pelvis but according to the images provided, this does not seem to be the case here. Hence the most probable option is an endoscopic combined intra-renal surgery, with a transperitoneallaparoscopic/robotic-assisted percutaneous nephrolithotomy, combined with flexible URS. After access to the abdomen and pneumoperitoneum are achieved, insertion of three trocars is done and dissection of intestine away from the pelvis of the

kidney until a direct percutaneous-kidney route can be achieved. After release of pneumoperitoneum for reducing the puncture distance as much possible – while maintaining minimal visual field necessary, a classical PNL is performed under direct vision of the puncturing process, and fragmentation is performed. Simultaneously, the retrograde access can be utilized for contrast injection as needed, for fragmentation with least possible irrigation and ultimately for a ureteral stent insertion. Optimal antibiotic therapy must be given perioperatively and the patient should be informed regarding potential complications like urinary leakage that would necessitate prolonged ureteral stenting and/or bladder catheterisation.

Laparoscopic pyelolithotomy preferred option Comments by Prof. Walter Strohmaier, Coburg (DE)

The CT scan shows a large renal pelvic stone mass with only few calyceal branches in a renal pelvic kidney. As the calyces do not look wide, a uretero-pelvic junction obstruction is unlikely. Due to the recurrent febrile urinary tract infections, there is a definitive indication for therapy. All kind of potential therapies as discussed in the following section should be done under appropriate antibiotic therapy.

Compared with the right kidney, the contrast medium enhancement in the venous phase seems to be less in the left kidney. Therefore, first I would assess the split renal function by a dynamic renal scintigraphy (Tc-99m-MAG3). If the left pelvic kidney´s function is less than 20% I would recommend a laparoscopic nephrectomy. If it is better, I would remove the stone. A percutaneous approach (percutaneous nephrolithotomy) which is the primary option for staghorn stones in normal kidneys may be difficult as the chance to find a window free from intestinal overlay is low. Retrograde intrarenal surgery and extracorporeal shock wave lithotripsy are no primary options as the stone free rates in those large stones are low and stone regrowth is very likely.

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The stone mass is predominantly located in the wide renal pelvis and there are only small calyceal branches. This allows for a laparoscopic pyelolithotomy. A complete stone retrieval by a renal pelvic incision is likely in the present situation. If necessary, the laparoscopic pyelolithotomy may be combined with intraoperative pyeloscopy through one of the laparoscopy ports. The chance to obtain a stone free status is very high by this approach. For drainage, I would insert a double-J and a urethral catheter. The renal pelvis is closed by a 4x0 barbed mid-term absorbable running suture. My personal experience as well as several case reports in the literature show that this approach can be performed successfully. If there is not enough

expertise in the laparoscopic technique, the same operation could be performed as an open procedure.

Case study No. 64 continued Open pyelolithotomy was performed which proved difficult due to dense inflammatory adhesions. Most of the stone could be removed but a residual upper calyceal fragment remained. The postoperative course was uneventful, concurrent urinary tract infection was treated antibiotically. Four weeks later, the remainder of the stone was treated by flexible ureteroscopy with laser lithotripsy successfully.

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7


Key articles from international medical journals Dr. Francesco Sanguedolce Section editor Barcelona (ES)

fsangue@ hotmail.com

Surgical lessons from China and Italy on the novel coronavirus outbreak As elective operations are being cancelled and surgeons are called upon to perform emergency or cancer surgery only, precautions when operating on patients who are potentially or proven COVID-19 positive are of utmost importance. First in China, then in Europe, and particularly in Italy, the sudden and rapidly exponential afflux of patients in need of simple or intensive care became the omnipresent and urgent preoccupation of health care workers. The pandemic has radically modified the architecture of existing health facilities. The Centres for Disease Control and Prevention and the American College of Surgeons recently recommended to stop elective surgery and to take general precautions, but there is little knowledge on the pragmatic aspects of surgery.

surgical smoke and the management of intraoperative aerosol when teaching. 8) Raise the awareness of occupational protection among operating staff. 9) Establish new standards of practice for admitting patients in the future. This outbreak not only raises challenges to minimally invasive surgery today, but it also reminds surgeons that we need stronger occupational protection in the future. There is an urgent need for a strict protocol to accurately manage the artificial pneumoperitoneum and the hazards of aerosol diffusion for surgeons.

Source: Minimally invasive surgery and the novel coronavirus outbreak: lessons learned in China and Italy. Min Hua Zheng, Luigi Boni, Abe Fingerhut. Ann Surg. 2020 Mar 26. doi: 10.1097/ SLA.0000000000003924. [Epub ahead of print].

Should PMSA PET-CT be used prior to treatment of high-risk localised PC?

Prediction of prostate cancer prognosis and subsequent choice of appropriate treatment depends on accurate staging. Unfortunately, standard of care conventional imaging with CT and bone scan has insufficient sensitivity and therefore biochemical In laparoscopic surgery, an essential part of the relapse following treatment with curative effect is technique is the establishment and maintenance of an common. Emerging data suggest PSMA PET-CT artificial pneumoperitoneum. With this comes the risk demonstrates improved sensitivity, especially in the of aerosol exposure for the operation team. Ultrasonic recurrent setting. The proPSMA trial aimed to scalpels or electrical equipment commonly used in investigate its diagnostic utility as a replacement for laparoscopic surgery can easily produce large conventional imaging. amounts of surgical smoke. Particularly, the lowtemperature aerosol from ultrasonic scalpels cannot Should men with PMSA-detected effectively deactivate the cellular components of a virus in patients. nodal or metastatic disease be The risk of 2019-nCoV infection aerosol is no exception. After using electrical or ultrasonic equipment for 10 minutes, the particle concentration of smoke in laparoscopic surgery is significantly higher than that in traditional, open surgery. The reason may be that due to low-gas mobility in the pneumoperitoneum, the aerosol formed during the operation tends to concentrate in the abdominal cavity. Sudden release of trocar valves, non-air-tight exchange of instruments or even small abdominal extraction incisions can potentially expose the health care team to the pneumoperitoneum aerosol. The risk is higher in laparoscopic than in traditional, open surgery. This outbreak thus poses a great challenge to the clinical work of surgeons who practise minimally invasive surgery.

This outbreak not only raises challenges to minimally invasive surgery today, but it also reminds surgeons that we need stronger occupational protection in the future. Based on their recent experience, the authors recommend the following: 1) All surgery patients must complete preoperative health screening, and all medical personnel must comply with the tertiary protection regulations. 2) Special attention should be paid to the establishment of pneumoperitoneum, haemostasis and cleaning at trocar sites to prevent and manage aerosol dispersal. 3) Keep intraoperative pneumoperitoneum pressure and CO2 ventilation at the lowest possible levels. Reduce the Trendelenburg position as many times as possible. 4) The power settings of electrocautery should be as low as possible. Avoid long dissecting times on the same spot with electrocautery or ultrasonic scalpels. 5) All protocols involving postoperative cleaning and disinfection should comply with governmental and scientific society instructions. 6) Divide hospitals into two main categories: dedicated hubs for positive COVID-19 patients and others for emergency surgery and urgent oncological procedures in negative COVID-19 patients. 7) Strengthen the awareness of the hazards caused by Key articles

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offered systemic treatment at the outset or should they be offered additional site-specific therapy? Or both? This was a multi-centre, two-arm, randomised trial. Patients with histologically confirmed prostate cancer and at least one of the following high-risk features were eligible: PSA > 20 ng/ml, ISUP grade group 3-5 or clinical stage T3 or worse. Patients were randomly assigned to conventional imaging with CT and bone scanning or gallium-68 PSMA-11 PET-CT. First-line imaging was done within 21 days following randomisation. Patients underwent second-line cross-over imaging within 14 days, unless three or more distant metastases were identified on initial scans. Additional confirmatory studies done at the discretion of the treating doctor were recorded. When feasible, biopsy confirmation of distant metastasis was strongly encouraged. Patients who had surgery underwent pelvic lymph node dissection at the discretion of the treating urologist. At six months, men underwent repeat imaging as per randomised group with cross-over if imaging evidence of N1 or M1 disease at baseline was found, or in the presence of biochemical or clinical suspicion of residual or recurrent disease. The primary outcome of the trial was accuracy of first-line imaging for identifying either pelvic nodal or distant metastatic disease. Cases were considered positive if one of the following hard criteria were met: histopathology showing prostate adenocarcinoma or change of a bone lesion to a sclerotic or blastic form on follow-up imaging. Cases were also considered positive if at least three soft criteria were met. These included typical appearance of multi-focal metastatic disease, a metastatic lesion on an imaging modality other than the one done as the index scan, increase in size or number of lesions from one imaging exam to the next, decrease in size or number of lesions from one imaging exam to the next following appropriate treatment, lesion associated with clinical symptoms suggesting malignancy, patient received localised treatment for imaging finding, increase in PSA in keeping with clinical scenario of progression or decrease in response to treatment, and unequivocal

persistence of positive finding on repeating imaging at 6 months in patients with a PSA concentration of more than 0.2 ng/mL at least 3 weeks following prostatectomy. 339 men, median age 68.1 years, were assessed for eligibility and 302 men were randomly assigned. 152 (50%) men were randomly assigned to conventional imaging and 150 (50%) to PSMA PET-CT. Of 295 (98%) men with follow-up, 87 (30%) had pelvic nodal or distant metastatic disease. PSMA PET-CT had a 27% (95% CI 23–31) greater accuracy than that of conventional imaging (92% [CI 88–95] vs. 65% [CI 60–69]; p < 0·0001). We found a lower sensitivity (38% [CI 24–52] vs. 85% [CI 74–96]) and specificity (91% [CI 85–97] vs. 98% [CI 95–100]) for conventional imaging compared with PSMA PET-CT. Subgroup analyses also showed the superiority of PSMA PET-CT (AUC 91% vs. 59% [32% absolute difference; 28–35] for patients with pelvic nodal metastases, and 95% vs. 74% [22% absolute difference; 18–26] for patients with distant metastases). PMSA PET-CT showed a superior diagnostic accuracy than conventional imaging, a result supported by prior retrospective studies. The question is what we should do with this information. From the STAMPEDE study we know that men with high-risk disease and even those with low-volume metastatic disease benefit from local therapy combined with systemic therapy when based on conventional imaging. So, should men with PMSA-detected nodal or metastatic disease be offered systemic treatment at the outset or should they be offered additional site-specific therapy? Or both?

Source: Prostate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (proPMSA): a prospective, randomised multi-centre study. Hofman MS, Lawrentschuk N, Francis RJ, et al. Lancet. 2020; doi.org/10.1016/S0140-6736(20)30314-7

Risk factors, prognostic indicators and shedding of virus after COVID-19 infection In December 2019, Wuhan (CN) experienced an outbreak of coronavirus disease 2019 (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The aim of this study was to report risk factors for mortality, a detailed clinical course of illness, and viral shedding. Investigators performed a retrospective, multicentre cohort study, which included all adult inpatients (≥ 18 years old) with laboratory-confirmed COVID-19 from two hospitals in Wuhan who had been discharged or had died by 31 January 2020. Demographic, clinical, treatment, and laboratory data, including serial samples for viral RNA detection, were extracted from electronic medical records and compared between survivors and non-survivors. Univariable and multivariable logistic regression methods were used to explore the risk factors associated with in-hospital death.

The potential risk factors, a high SOFA score, and a d-dimer greater than 1 μg/mL could help clinicians identify patients with a poor prognosis at an early stage. 191 patients were included in the study, of whom 137 were discharged and 54 died in hospital. 91 (48%) patients had a comorbidity, with hypertension being the most common one (58 [30%] patients), followed by diabetes (36 [19%] patients). Multivariable regression showed increasing odds of in-hospital death associated with older age (odds ratio 1,10, 95% CI 1,03-1,17, per year increase; p = 0.0043), higher Sequential Organ Failure Assessment (SOFA) score (5,65, 2,61-12,23; p < 0,0001), and d-dimer greater than 1 μg/mL (18·42, 2·64-128·55; p = 0·0033) on admission. Median duration of viral shedding was 20,0 days (IQR 17,0-24,0) in survivors. The longest observed duration of viral shedding in survivors was 37 days.

Dr. Guillaume Ploussard Section editor Toulouse (FR)

g.ploussard@ gmail.com The potential risk factors, a high SOFA score, and a d-dimer greater than 1 μg/mL could help clinicians identify patients with a poor prognosis at an early stage. Prolonged viral shedding provides the rationale for a strategy of isolation of infected patients and optimal antiviral interventions in the future.

Source: Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z et al. Lancet. 2020 Mar 28;395 (10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. PMID: 32171076

Systematic prostate biopsy, MRI target, or both? It has become clear in recent years that transrectal ultrasound-guided 12-core systematic biopsy is associated with diagnostic inaccuracy. This results in the overtreatment of indolent cancers and the undertreatment of aggressive disease. MRI-targeted biopsies of suspicious imaging findings result in a higher rate of detection of high-grade cancers. There is still controversy as to whether the systematic biopsy should still be performed and whether previous biopsy status should affect the type of biopsy method that is selected.

There is still controversy as to whether the systematic biopsy should still be performed. Men with an elevated PSA level or an abnormal DRE were eligible to undergo prostate MRI. Scans were performed with a 3T MRI and an endorectal coil and lesions were given a PI-RADS score. Patients with a prostate lesion on MRI who consented to undergo a biopsy were eligible for enrolment. Patients underwent both MRI-targeted and systematic biopsy. Targeting was performed using software to ensure accuracy. The primary outcome was cancer detection according to ISUP grade group. Among the men who underwent radical prostatectomy as primary treatment, upgrading and downgrading of grade group from biopsy to whole-mount histopathological analysis of surgical specimens were recorded. Secondary outcomes were the detection of cancers of grade group 2 or higher and grade group 3 or higher, cancer detection stratified by previous biopsy status and by grade reclassification between biopsy and radical prostatectomy. A total of 2,103 men were included, the majority of whom (79.3%) had undergone a previous negative biopsy. Cancer was diagnosed in 1,312 men (62.4%) by a combination of the two methods (combined biopsy) and 404 (19.2%) underwent radical prostatectomy. Cancer detection rates on MRItargeted biopsy were significantly lower than on systematic biopsy for ISUP grade group 1 cancers and significantly higher for ISUP grade groups 3 through 5 (p < 0.01 for all comparisons). Combined biopsy led to cancer diagnoses in 208 more men (9.9%) than with either method alone and to upgrading to a higher grade group in 458 men (21.8%). However, if only MRI- target biopsies had been performed, 8.8% of clinically significant cancers (grade group ≥ 3) would have been misclassified. Among the 404 men who underwent subsequent radical prostatectomy, combined biopsy was associated with the fewest upgrades to grade group 3 or higher on histopathological analysis of surgical specimens (3.5%) as compared with MRI-targeted biopsy (8.7%) and systematic biopsy (16.8%). This study demonstrated that a combination of MRI-targeted and systematic biopsies improves the likelihood that the biopsy findings are predictive of

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disease-free survival (HR 0,45, 95% CI 0,30–0,68; p = 0,0001) at a median follow-up of 30,3 months (IQR 18,0–47,5). Three-year event-free estimates were 71% (95% CI 61–78) and 46% (36–56) for chemotherapy and surveillance, respectively. Analysis of overall survival is planned once 88 deaths have occurred or all participants have at least 2 years follow-up (whichever occurs first). 55 (44%) of 126 participants who started chemotherapy had serdartekgul@ acute grade 3 or worse treatment-emergent adverse gmail.com events, which accorded with frequently reported events for the chemotherapy regimen. 31 (25%) of patients allocated to chemotherapy discontinued the true pathological nature of the patient’s disease. MRI-targeted biopsy alone would require less early. Five (4%) of 129 patients managed by biopsies and leads to 5% fewer diagnoses of clinically surveillance had acute grade 3 or worse emergent insignificant cancers but is associated with a 30.9% adverse events. No treatment-related deaths were reported. rate of upgrading the ISUP grade group on wholemount histopathological analysis. This study suggests patients need to be counselled about this risk of This study has shown that gemcitabine–platinum chemotherapy initiated within 90 days after missing or undergrading tumours with MRI-targeted biopsy alone. nephroureterectomy significantly improves diseasefree survival in patients with locally advanced UTUC. Source: MRI-targeted, systematic and combined Chemotherapy was also associated with improved biopsy for prostate cancer diagnosis. Ahdoot M, metastasis-free survival with acceptable acute toxic effects consistent with existing data, and with no Wilbur AR, Reese SE, et al. more than a transient effect on patient-reported NEJM. 2020; 382:917-28 quality of life. It is probably too small for a valid sub-group analysis, and clearly survival data is awaited, but perseverance to collect appropriate Adjuvant chemotherapy: patient data over such a long period and across many A new standard? centres has shown UTUC patients will benefit from adjuvant chemotherapy. Upper tract urothelial carcinoma (UTUC) is rare. Scant symptoms and delayed diagnosis results in Source: Adjuvant chemotherapy in upper tract urothelial carcinoma (the POUT trial): a phase 3, tumours that are often (56%) muscle-invasive at diagnosis resulting in poor survival figures with open-label, randomised controlled trial. Birtle A, Johnson M, Chester J, et al. 50% of patients diagnosed dying of the disease. Robust evidence for the effectiveness of neoadjuvant Lancet. 2020; doi.org/10.1016/S0140-6736(20)30415-3 platinum-based chemotherapy for muscle invasive bladder cancer led to the development of the POUT study. Although a neoadjuvant approach is attractive Predictive score for allograft for patients with UTUC, particularly when the loss of failure in large international renal function associated with nephrectomy is considered, the unreliability of preoperative UTUC cohorts staging and histopathology would probably result in overtreatment for some patients and undertreatment for others. Consequently, the This analysis was undertaken to develop and validate an integrative system to predict long-term kidney authors set out to evaluate the effect of adjuvant platinum-based chemotherapy on disease-free allograft failure. Therefore, an international retrospective cohort study was undertaken with three survival, overall survival, safety, and quality of life after radical nephroureterectomy in patients with cohorts including kidney transplant recipients from 10 locally advanced UTUC. academic medical centres from Europe and the United States. POUT is a phase 3, open labelled, randomised, controlled trial. Patients with UTUC after An integrative, accurate, and readily nephroureterectomy staged as either pT2–T4 pN0–N3 M0 or pT any N1–3 M0 were enrolled and randomly implementable risk prediction score allocated (1:1) to either surveillance or four 21-day for kidney allograft failure has cycles of chemotherapy. Chemotherapy was either cisplatin (70 mg/m2) or carboplatin (area under the been developed, which can be used curve [AUC]4·5/AUC5, for glomerular filtration rate < across centres worldwide. 50 mL/min only) administered intravenously on day 1 and gemcitabine (1000 mg/m2) administered intravenously on days 1 and 8; chemotherapy was The derivation cohort consisted of 4,000 initiated within 90 days of surgery. Stratification was consecutive kidney recipients prospectively planned for platinum agent (cisplatin vs. carboplatin), recruited in four French centres between 2005 and preoperative radiologically or pathologically assessed 2014. The validation cohorts were 2,129 kidney recipients from three centres in Europe and 1,428 nodal involvement (N0 vs. N1 vs. N2 vs. N3), status of from three centres in North America, recruited microscopic surgical margins (positive vs. negative) between 2002 and 2014. Additional validation was and treating centre. Follow-up included standard performed in three randomised controlled trials cystoscopic, radiological and clinical assessments. (NCT01079143, EudraCT 2007-003213-13, and Participants were followed up at 3, 6, 9 and 13 NCT01873157). months, then every 6 months to 36 months and then annually. The primary endpoint was disease-free survival analysed by intention. A pre-planned interim The main outcome measure was allograft failure (return to dialysis or pre-emptive retransplantation). analysis met the efficacy criterion for early closure In addition, 32 candidate prognostic factors for kidney after recruitment of 261 participants. allograft survival were assessed. Prof. Serdar Tekgül Section Editor Ankara (TR)

This study has shown that gemcitabine–platinum chemotherapy initiated within 90 days after nephroureterectomy significantly improves disease-free survival in patients with locally advanced UTUC. Over 5 years, 261 participants, median age 68.5 years, were enrolled from 57 of 71 open study sites. 245 (94%) of 260 participants were staged pT2–T3; of these, 223 (91%) were also staged N0. 166 (64%) participants had GFR of 50 mL/min or higher. 132 patients were assigned chemotherapy and 129 surveillance. One participant allocated to chemotherapy withdrew consent for data use after randomisation and was excluded from analyses. Adjuvant chemotherapy significantly improved Key articles

March/May 2020

Among the 7,557 kidney transplant recipients, 1,067 (14.1%) allografts failed after a median posttransplant follow-up time of 7.1 years (interquartile range 3.5-8.7). In the derivation cohort, eight functional, histological, and immunological prognostic factors were independently associated with allograft failure. In the multivariable analysis, a post-transplant risk evaluation (p = 0.005) was carried out. Then, the allograft functional parameters, including eGFR (p < 0.001) and proteinuria (logarithmic transformation, p < 0.001) and the allograft histological parameters, including interstitial fibrosis and tubular atrophy (p = 0.031), microcirculation inflammation defined by glomerulitis and peritubular capillaritis (p = 0.001), interstitial inflammation and tubulitis (p = 0.014) and transplant glomerulopathy (p = 0.004) and the recipient’s immunological profile as defined by the presence and concentration of the immunodominant circulating anti-HLA donor specific antibodies (p < 0.001), were combined into a risk prediction score.

This score showed accurate calibration and discrimination (C index 0.81, 95% confidence interval 0.79 to 0.83). The performance of the score was also confirmed in the validation cohorts from Europe (C index 0.81, 0.78 to 0.84) and the US (0.80, 0.76 to 0.84). The score system showed accuracy when assessed at different times of evaluation posttransplant, was validated in different clinical scenarios including type of immunosuppressive regimen used and response to rejection therapy, and outperformed previous risk prediction scores as well as a risk score based solely on functional parameters including estimated glomerular filtration rate and proteinuria. Finally, the accuracy of the risk score in predicting long-term allograft loss was confirmed in the three randomised controlled trials. Thus, an integrative, accurate, and readily implementable risk prediction score for kidney allograft failure has been developed, which can be used across centres worldwide and in common clinical scenarios. The risk prediction score may help to guide monitoring of patients and further improve the design and development of a valid and early surrogate endpoint for clinical trials.

Source: Prediction system for risk of allograft loss in patients receiving kidney transplants: international derivation and validation study. Loupy A, Aubert O, Orandi BJ, Naesens M, Bouatou Y, Raynaud M, Divard G, Jackson AM, Viglietti D, Giral M, Kamar N, Thaunat O, Morelon E, Delahousse M, Kuypers D, Hertig A, Rondeau E, Bailly E, Eskandary F, Böhmig G, Gupta G, Glotz D, Legendre C, Montgomery RA, Stegall MD, Empana JP, Jouven X, Segev DL, Lefaucheur C. BMJ. 2019; 17;366:l4923. doi: 10.1136/bmj.l4923. Clinicaltrials.gov NCT03474003

Post-biopsy complications: Is TREXIT the answer ? The development of imaging-targeted biopsy schemes with fewer cores combined with the infectious risk induced by transrectal (TR) route has led to the recent promotion of transperineal (TP) prostate biopsies in different meetings and publications. However, only small studies have compared both routes in terms of complications in the MRI-directed diagnostic pathway. Thus, it remained unclear if TP generates fewer readmissions than TR biopsies. In the present series, the authors have analysed the National Prostate Cancer Audit database in the UK between 2014 and 2017. Overall, 76,630 patients undergoing prostate biopsies have been included and compared according to the type of biopsy (TP versus TR). Hospital data were used to identify patients staying overnight after the procedure and those readmitted for complications (sepsis, urinary retention, haematuria). Most patients (81.4%) underwent TR biopsies (13,723 TP biopsies). However, patients undergoing a TP biopsy tended to have more recent biopsies, were younger on average and were more likely to have comorbidities (as assessed by the Charlson comorbidity score).

Prof. Oliver Hakenberg Section Editor Rostock (DE)

Oliver.Hakenberg@ med.uni-rostock.de compared to previous publications which frequently included less than 5% TP biopsies. Minor adverse effects such as duration of bleeding, pain during and after the procedure, discomfort, or erectile dysfunction have not been considered. An oncological endpoint such as cancer detection rate or quality of pathology assessment was also missing. Interestingly, the lower risk of sepsis obtained by TP was counterbalanced by a higher risk of readmission because of urinary retention which, by itself, could increase the risk of secondary infection due to bladder catheterisation. Thus, the debate is still open. Maybe until the decreasing effectiveness of antibiotic prophylaxis definitively tips the scales toward TP biopsies over time.

Source: Comparison of complications after transrectal and transperineal prostate biopsy: a national population-based study. Berry B, Parry MG, Sujenthiran A, et al. BJU Int. 2020;10.1111/bju.15039. doi:10.1111/bju.15039

Predictive factors of urinary incontinence after HoLEP The goal of this investigation was to evaluate predictive factors of urinary incontinence (UI) after holmium laser enucleation of the prostate (HoLEP). Patients (n = 2,346) were included in a retrospective multicentric study from 2012 to 2017. Patients' characteristics (age, BMI, percentage with diabetes), preoperative data (IPSS score, whole gland volume, urinary drainage), operative data (enucleation time, enucleation efficiency, tissue enucleated weight, total delivered energy) and postoperative data were recorded. Absence of UI was defined as no pads at 3 and 6 months. Surgeon experience was stratified in three categories: beginners (< 21 cases), intermediate (21-40 cases) and experienced (> 40 cases). Multivariate logistic regression analysis was performed.

Surgeon experience with at least 40 cases was the main predictive factor of decreased 3 months UI after HoLEP …

UI was observed in 14.5% of the patients (340/2,346) at 3 months (95% CI 13-16%) and in 4.2% (98/2,346) at 6 months (95% CI 3-5%). On multivariate analysis at 3 months, increasing age (OR per SD = 1.3 [1.14-1.48]), elevated BMI (OR per SD = 1.23 [1.09TP patients were more likely to stay overnight (12.3% 1.38]), preoperative urinary drainage (OR = 0.62 versus 2.4%) than those undergoing TR biopsy. [0.45-0.85]), increasing enucleated tissue weight Patients who had a TP biopsy were less likely to be (OR per SD = 1.29 [1.16-1.45]) and experienced readmitted because of sepsis (1% versus 1.4%), but surgeon with at least 40 cases (OR = 0.56 [0.42-0.75]) more likely to be readmitted because of urinary were significantly associated with increased or retention (1.9% versus 1%). At readmission, TP decreased UI. At 6 months, increasing age (OR per patients had a shorter mean of stay compared with TR SD = 1.25 [1.01-1.53]), elevated BMI (OR per SD = 1.25 patients (5.1 versus 6.5 days). No statistical difference [1.03-1.5]), increasing whole gland volume (OR per was observed regarding haematuria. one SD log = 1.24 [1.01-1.53]) and diabetes disorder (OR = 1.7 [1.03-2.78]) were significantly associated with increased UI.

Interestingly, the lower risk of sepsis obtained by TP was counterbalanced by a higher risk of readmission.

This study has several limitations, including the lack of relevant data regarding the number of cores taken, the number of previous biopsies, and the type of anaesthesia. Moreover, only patients with a diagnosis of prostate cancer were included, the authors were unable to report on biopsies carried out in patients with benign pathology findings. However, to date it represents the largest population-based study assessing the comparative profile of complications between TP and TR by evaluating the post-procedure readmission rate. The TP study was also well powered

In summary, UI after HoLEP was observed in 14.5% of the patients at 3 months and 4.2% at 6 months, with stress UI in half of the cases. Surgeon experience with at least 40 cases was the main predictive factor of decreased 3 months UI after HoLEP, while diabetes disorder was the main predictive factor of increased UI at 6 months.

Source: Predictive factors of urinary incontinence after holmium laser enucleation of the prostate: a multicentric evaluation. Houssin V, Olivier J, Brenier M, Pierache A, Laniado M, Mouton M, Theveniaud PE, Baumert H, Mallet R, Marquette T, Villers A, Robert G, Rizk. World J Urol. 2020 Mar 26. doi: 10.1007/s00345-02003169-0. [Epub ahead of print]

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Mr. Philip Cornford Section editor Liverpool (GB)

Source: Importance of long-term follow-up after endoscopic management for upper tract urothelial carcinoma and factors leading to surgical management. Mohapatra A, Strope SA, Liu N, et al. Int Urol Nephrol. 2020 Mar 11. doi: 10.1007/s11255-02002439-5. [Epub ahead of print]

philip.cornford@ rlbuht.nhs.uk

From UTUC to radical nephroureterectomy: Which factors cause progression? The endourological management of upper tract urothelial cancer (UTUC) is an emerging treatment option for low-risk UTUC patients. However, it involves a strict and invasive follow-up, alternating imaging tests involving high-dose radiation exposure (uro-CT scan) with endoscopic revision of the upper urinary tract. The EAU guidelines have changed indication and inclusion criteria in the last few years, lastly identifying the low-risk UTUC tumours as those presenting with a single lesion, low-grade both cytologically and in the endoscopic biopsy, and no evidence of a muscular invasion during CT urography.

In the Cox regression analysis, factors significantly relating to the progression requiring a RNU were the presence of a visible lesion during the endoscopy and a positive endoscopic biopsy (either low or high-grade).

In both the unmatched and matched cohort, there was no significant difference in the death-censored graft survival at 10 years between the withoutarteriosclerosis and with-arteriosclerosis groups. The with-arteriosclerosis group had a higher incidence rate of overall rejection than the withoutWhatever the selection criteria used to define ideal arteriosclerosis group in both the unmatched (p < prostate cancer candidates for active surveillance, the 0.027) and matched (p < 0,.061) cohorts. The with-arteriosclerosis group had significantly higher risk of misclassification remains. The unwanted rate of significant cancer not detected by the combination chronic antibody-mediated rejection than the of favourable post-biopsy parameters varies from 10% without-arteriosclerosis group (p < 0.007) in the to 30% in the literature. The advent of prostate unmatched cohort. The with-arteriosclerosis group imaging and the widespread use of imaging-directed had a significantly lower estimated glomerular filtration rate in recipients, but there was no biopsy aim at decreasing this risk without drastically reducing the number of potential low-risk candidates. significant difference after matching. The incidence rates of calcineurin inhibitor nephrotoxicity and post-transplant anaemia were significantly higher in In the present series, the authors have built a statistical model incorporating MRI findings to predict the with-arteriosclerosis group than in the withoutarteriosclerosis group in both the unmatched and more accurately the risk of unfavourable disease in radical prostatectomy specimens. matched cohorts. Long-term postoperative kidney function of living donors was lower in the withThe primary endpoint was unfavourable disease, arteriosclerosis group. defined as the presence of grade group 3 or higher disease and/or the presence of pT3 and/or pN1 Living donor kidney graft with disease in surgery specimens. Several models were tested including several PIRADS scores and the arteriosclerosis seems to affect suspicion of extracapsular extension on MRI. the incidence of rejection and Comparisons with standard active surveillance criteria (PRIAS’, John Hopkins’, and EAU’s criteria for low risk complications in the recipient and and low-volume intermediate risk) were also the postoperative kidney function in performed.

Active surveillance selection based on MRI findings and risk calculator

Overall, 1,837 patients undergoing RP were included among whom 11.4% fulfilled the most stringent However, few centres in the world have developed Johns Hopkins criteria and 53.7% the EAU low expertise to appropriately include the nephronvolume intermediate risk criteria. The proportion of sparing approach electively in their practice, as data unfavourable disease according to these standard in the literature are still scarce and costs of the criteria ranged from 17% to 30%. The incorporation necessary equipment and of the number of of PIRADS and extracapsular extension scores on procedures needed are high. MRI (in addition to PSA density and biopsy grade group) significantly improved the accuracy of the Recently, the outcomes from two high-volume centres model and had a greater area under curve in the United States have been published in a study compared to the four referenced active surveillance comparing the clinical and pathological characteristics criteria. The adoption of such a model could also of UTUC patients initially managed endoscopically, of increase the proportion of patients eligible for active whom 81 could remain in the nephron-sparing surveillance when using a threshold of 25%. management versus 89 who eventually needed a radical nephroureterectomy (RNU) for progression in The model presented is interesting the follow-up. They selected patients who underwent two endoscopies at least 3 months apart, between but must be validated externally. 2000 and 2014. In this retrospective analysis, the authors collected patients’ and tumours’ clinical-pathological data to find significant factors associated with progression after endoscopic management (EM). Median follow-up time was 24.8 and 41.5 months for EM and RNU patients respectively.

The development of a new imaging-based nomogram, combining clinical, biopsy, and MRI findings, is needed to increase the safety of active surveillance inclusion and the proportion of candidates. The model presented in this study is interesting but must be validated externally. Moreover, this model did not incorporate the biopsy In the Cox regression analysis, factors significantly grade group obtained by MRI-targeted cores, which relating to the progression requiring a RNU were the could more accurately reflect the final grade group presence of a visible lesion during the endoscopy and in RP specimens. Given the superiority of targeted a positive endoscopic biopsy (either low or highbiopsy over systematic biopsy for clinically grade). Moreover, the higher the Charlson comorbidity significant prostate cancer detection and for grade index was, the lower the chances were that the prediction, the grade group of the targeted biopsy patient required a RNU. In the Kaplan-Meyer survival might represent the most accurate parameter to analysis, the proportion of patients switching to RNU consider. It should be integrated in all new models at 5 years was 80%, suggesting that most of the in order to improve their prognostic performance. patients were kept in the endoscopic management only in the short term. Source: A novel nomogram to identify As the authors did not specify which criteria were considered for patients to switch from EM to RNU, it is possible that patients were offered RNU as soon as they developed a recurrence found during ureteroscopy, unless the presence of multiple comorbidities contraindicates (relatively or absolutely) a more invasive approach. Another argument is the long patient recruitment period: in a span of 14 years, many changes have been introduced in terms of technology, technique and indications. Thus, it is reasonable to suppose that the outcomes are affected by an important degree of heterogeneity. Although the authors should be commended for their efforts in exploring the appropriateness of endoscopic management of UTUC, due to the study’s considerable limitations, many questions remain unanswered. Key articles

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The influence of arteriosclerosis in pretransplant biopsy on long-term outcomes and complications was evaluated in both unmatched (n = 1,351, without arteriosclerosis n = 788 vs. with arteriosclerosis n = 563) and propensity score-matched cohorts (n = 984, without arteriosclerosis n = 492 vs. with arteriosclerosis n = 492) of adults who underwent living-kidney transplant.

candidates for active surveillance amongst patients with International Society of Urological Pathology (ISUP) Grade Group (GG) 1 or ISUP GG2 prostate cancer, according to multiparametric magnetic resonance imaging findings. Luzzago S, de Cobelli O, Cozzi G, et al. BJU Int. 2020;10.1111/bju.15048. doi:10.1111/bju.15048

Live donor transplants with arteriosclerosis carry higher risk of rejection This study investigated the long-term outcome and complications of living kidney grafts with arteriosclerosis to those without abnormal findings diagnosed using pretransplant graft biopsy. It also assessed the impact of the arteriosclerosis in living-donor kidneys.

the donor.

Living donor kidney graft with arteriosclerosis seems to affect the incidence of rejection and complications in the recipient and the postoperative kidney function in the donor. Long-term careful observation is therefore required for both the recipients who received grafts with arteriosclerosis and the donors who had kidneys with arteriosclerosis.

Source: Impact of donor-related arteriosclerosis in pre-transplant biopsy on long-term outcome of living-kidney transplantation: A propensity score-matched cohort study. Kakuta Y, Okumi M, Kanzawa T, Unagami K, Iizuka J, Takagi T, Ishida H, Tanabe K. Int J Urol. 2020 Mar 11. doi: 10.1111/iju.14212. [Epub ahead of print]

Urologists on secondment during COVID-19 outbreak in Singapore Since it was first reported in Wuhan, China, in December 2019, the novel coronavirus has rapidly spread worldwide. On 30 January 2020, the World Health Organisation (WHO) declared the situation a public health emergency of international concern and on 11 February 2020 named the disease COVID-193.

Since the 2003 SARS outbreak that killed 33 people in Singapore (including healthcare workers), the nation has improved its national outbreak readiness. Even before the first confirmed case in Singapore on 23 January 2020, authorities including the Ministry of Health (MOH) raised national alert levels and implemented wide-ranging, multiagency public health measures. By 6 February 2020 and up to 19 February 2020, Singapore had the highest number of confirmed cases outside of mainland China. The rate of contagious spread has since been overtaken by other affected countries. Singapore's sustained national efforts in early detection and containment have been acknowledged by Harvard University and the WHO. Since the 2003 severe acute respiratory syndrome (SARS) outbreak that killed 33 people in Singapore (including healthcare workers), the nation has improved its national outbreak readiness by

increasing training of infectious disease control personnel and improving infrastructure. The National Centre for Infectious Disease (NCID), a purpose-built 330-bed facility, officially opened in September 2019. It is connected to Tan Tock Seng Hospital (TTSH), one of the largest acute hospitals in Singapore (1,700 beds and 9,000 staff). NCID contains a screening centre (SC), isolation and cohort wards, a high-level isolation unit, operating theatres, radiology suites and laboratories. At the forefront of the efforts in Singapore, the NCID SC operations required secondment of TTSH staff, with urologists among those deployed. The SC assessed patients in terms of travel or contact history, respiratory symptoms, fever, suspected or confirmed COVID-19 status, and primary health care referrals. Emergency physicians oversaw operations in consultation with infectious disease physicians. At all times, a quarter of the urology department complement of doctors was deployed to the SC, working 10-day rotations. This correspondence shares very early experience, highlighting the impact on urology practice, lessons learnt and the role of urologists in outbreaks.

Source: Stepping forward: urologists’ efforts during the COVID-19 outbreak in Singapore. Chan MC, Yeo SEK, Chong YL, Lee YM. Eur Urol. 2020 Mar 17. pii: S0302-2838(20)30145-7. doi: 10.1016/j.eururo.2020.03.004. [Epub ahead of print]

What effect does oestradiol have on OAB development during ovulation induction? The aim of this trail was to assess the effect of a sharp increase in oestrogen levels on overactive bladder (OAB) symptoms among women undergoing ovulation induction. 100 consecutive women (mean age 36.9 ± 5.2 years) who underwent IVF treatments were prospectively enrolled. Three validated questionnaires on urinary urgency (USIQ), urinary incontinence (MESA), and lower urinary tract symptoms (BFLUTS-SF) were used to evaluate patient's OAB symptoms before ovulation induction (low oestradiol level) and prior to ovum pickup (peak oestradiol level).

A higher oestradiol level appears to have a protective effect against the development of OAB symptoms during ovulation induction. Of the 100 women, 49 reported OAB symptoms prior to ovulation induction (mean USIQ severity score 33) and 51 women were asymptomatic. Of the 49 symptomatic women, 44 (90%) remained symptomatic (mean USIQ severity score 34) and five women became asymptomatic through ovulation induction. Of the 51 asymptomatic women, 24 (47%) developed de novo OAB symptoms, while 27 women (53%) remained asymptomatic through ovulation induction. The mean peak oestradiol level was significantly higher among women who remained asymptomatic in comparison to women with de novo OAB symptoms (2,069 versus 1,372 pg/ml respectively). Moreover, in most (63%) women who remained asymptomatic peak oestradiol levels were higher than 1,500 pg/ml, whereas in most (67%) women who became symptomatic peak oestradiol levels were lower than 1,500 pg/ml. The investigators conclude that a higher oestradiol level appears to have a protective effect against the development of OAB symptoms during ovulation induction. Furthermore, in most (63%) women who remained asymptomatic peak oestradiol levels were higher than 1,500 pg/ml. This finding may suggest a threshold for oestradiol activity in the lower urinary tract.

Source: The effect of a sharp increase in oestrogen levels on overactive bladder symptoms in women undergoing ovulation induction. Groutz A, Gold R, Gordon D, Azem F, Shimonov M, Amir H. Urology. 2020 Mar 16. pii: S0090-4295(20)30272-7. doi: 10.1016/j.urology.2020.03.006. [Epub ahead of print]

EAU EU-ACME Office

European Urology Today

March/May 2020


Prof. Truls Erik Bjerklund Johansen Section editor Oslo (NO)

Overall, despite the deterioration of functional outcomes after redo focal HIFU, the change in rates are minor. Patients need to be counselled accordingly before they decide what the most appropriate treatment option would be for them.

tebj@medisin.uio.no

Source: Evaluation of functional outcomes after a second focal high-intensity focused ultrasonography (HIFU) procedure in men with primary localized, non-metastatic prostate cancer: results from the HIFU Evaluation and Assessment of Treatment (HEAT) registry. Lovegrove CE, Peters M, Guillaumier S et al.

Functional outcomes after redo focal HIFU Focal treatment (FT) of prostate cancer is a relatively new treatment option still under investigation. With a half-gland or hockey-stick ablation and the advent of multiparametric MRI, a visible lesion can be targeted with a margin of 0.5-1 cm. Failure-free survival after focal treatment has been variably reported, depending on the definition of the failure. However, once the decision to undertake a second-line treatment is made, concerns may rise with respect to which option to offer. With regard to radical prostatectomy and prostate radiotherapy, the standard of care offered in high-volume, highly skilled focal therapy centres may include a redo treatment. This may include either a whole gland ablation or just another focal treatment, especially in patients who worry about the risk of developing de novo incontinence and/or erectile dysfunction.

This is a multicentre study from the HEAT (HIFU Evaluation and Assessment of Treatment) registry, collecting data from 6 centres in the UK specialised in HIFU for prostate cancer. However, evidence to support this redo treatment option is still missing. To shed more light on this treatment, a paper on the functional outcomes of a redo focal treatment with High-Intensity Focused Ultrasound (HIFU) was recently published. This is a multicentre study from the HEAT (HIFU Evaluation and Assessment of Treatment) registry, collecting data from 6 centres in the UK specialised in HIFU for prostate cancer. Most of the 821 patients, treated from 2005 to 2016, harboured low and intermediate risk-prostate cancer, although a small proportion of patients were diagnosed with a cT3 (12.1%) or an ISUP grade group > 2 (13.2%). A second focal HIFU was undertaken when a persistence or recurrence of the tumour was detected during a follow-up by in-field or out-of-field positive biopsy for clinically significant prostate cancer, or just with a Likert-5 lesion in-field, detectable at MRI with a rising PSA value. Functional outcomes were evaluated with validated patient-reported outcome questionnaires, namely the IPSS: the continence domain of the EPIC (Expanded Prostate Cancer Index Composite), and with a question from the IIEF (International Index of Erectile Function) addressing the ability of patients to have sufficient penetration for intercourse (scale from 0 no sexual activity to 5 - all the time). The time points were: baseline status (before first HIFU), 1-2 years, and 2-3 years after each focal treatment. Overall, redo focal HIFU was undertaken in 167 patients (20.3%); the number of patients included in the final analysis who returned their questionnaire was 355 (primary treatment group) and 65 (redo focal HIFU group). Interestingly, the authors reported a significant improvement in terms of IPSS mean score between baseline (before first HIFU) and before second HIFU (-1.3, p = 0.02), which was evened out by a symmetrical worsening in mean score after 2-3 years from second HIFU (+1.2, p = 0.003). Accordingly, IPSS mean score before first HIFU and after second HIFU was the same (9.5). There was a non-significant change of leak-free continent rates as well as of pad-free rates across all the relevant time points. In terms of erectile function, there was an overall significant deterioration from baseline to second HIFU, with a change in mean score of -1.1 (p = 0.008) between baseline and 2-3 years after second HIFU. However, there was no significant deterioration between pre- and post-second HIFU mean score. Key articles

March/May 2020

BJU Int. 2020 Jan 23. doi: 10.1111/bju.15004. [Epub ahead of print]

After searching and screening different literature databases (PubMed, Embase and Cochrane Library) according to the predefined inclusion/exclusion criteria, the authors eventually selected 8 studies, whose data on the effect of thiazide on renal stones recurrence and data on the 24-hours urinary calcium levels were then extracted and compared with the placebo/no medication groups. Interestingly, 5 trials were conducted in the 80s, two in the early ’90s and the latest one was published in 2006 only. All of the studies accounted for small sample sizes, with overall number of patients recruited ranging from 22 to 175 individuals. The quality assessment analysis showed an overall moderate quality of the selected studies, with no serious risk of bias.

The pooled risk ratio of new renal stone incidence in the relevant RCTs showed a protective effect of 2.27 times of the thiazide diuretics with respect to placebo/ no medication, as well as a reduced risk of 23% (95% CI:30-16, p = 0.0001). Nevertheless, important inconsistency was observed among the selected For most paediatric urologists, the surgical indications studies. With respect to the changes in 24-h calciuria for reflux are breakthrough febrile urinary tract level, the standardised mean difference was -18.59 in infections, persistent high-grade reflux, and reflux favour of patients taking thiazide diuretics. However, associated with acquired renal scarring. It is the dropout rate of the thiazide diuretics group was controversial whether surgical correction of persistent between 3.7 to 20% and was caused by the reflux is needed in older girls to prevent future UTI development of adverse events, among which fatigue, when they become sexually active or later in hypokalaemia, dizziness, muscle symptoms, etc. pregnancy.

Does anti-reflux surgery help prevent pregnancy-related complications?

The data available is very limited. There are no well-designed studies comparing pregnancy outcomes among women whose childhood vesicoureteral reflux (VUR) was and was not surgically repaired. Most of the case series and cohorts find relatively high incidences of UTI and pyelonephritis among pregnant women with a history of VUR, but there is very little to suggest that persistent VUR in itself is a risk factor for infection during pregnancy. Some studies suggest that UTI risk is higher among women who previously underwent anti-reflux surgery compared to those who did not, although these data are compromised by significant selection bias. Despite the long-standing expert opinion that unresolved VUR in girls should be repaired to reduce the risk of maternal and foetal morbidity during a subsequent pregnancy, there are very few data supporting this premise.

Available evidence is too poor to support routine correction of persistent reflux in older girls. In contrast, there is relatively strong evidence that maternal and foetal morbidity is higher when the mother is known to have renal scarring. Such women probably merit close surveillance during pregnancy for infection, hypertension and pre-eclampsia, and other problems. There is no good evidence to support routine anti-reflux surgery in girls to reduce urinary tract infection morbidity during future pregnancy, particularly in girls with lower grades of VUR and no renal scarring.

Source: Urology mythbusters: do we need to surgically correct vesicoureteral reflux in older girls to prevent problems in future pregnancy? (revision 1). Acuña C, López PJ, Sierralta MC, Kurtz MP, Nelson CP, Yankovic F. J Pediatr Urol. 2019 Dec;15(6):668-671. doi: 10.1016/j. jpurol.2019.08.008. Epub 2019 Aug 23. PubMed PMID: 31564587.

Meta-analysis: Long-term thiazide diuretics for prevention of renal stones not recommended For many years, thiazide diuretics have been recommended to treat stones with hypercalciuria based on evidence published in literature in the 80s and 90s. However, compliance to long-term treatment of stones is known to be quite low, especially in younger patients, with treatment benefits potentially counterbalanced by side effects.

… the dropout rate of the thiazide diuretics group was between 3.7 to 20% and was caused by the development of adverse events, among which fatigue, hypokalaemia, dizziness, muscle symptoms, etc. According to the GRADE (Grading of Recommendations, Assessment, Development and Evaluations) rating, the quality of evidence provided by the pooled analysis for the effect of thiazide in reducing the formation of new renal stone was low. With regard to the reduction of 24-h hypercalciuria, the GRADE rating was moderate. The main limitation of the SR was the heterogeneity of some studies, which assessed interventional and control group with other measures such as diet, increase of fluid intake or treatment with potassium citrate. Considering the unsubstantial net benefit of the intervention, the low evidence of the study, the inconsistency of the results, and the frequency of the adverse events, the authors concluded that the use of thiazide diuretics in reducing the recurrence of renal calculi cannot be recommended.

Source: Use of thiazide diuretics for the prevention of recurrent kidney calculi: a systematic review and meta-analysis. Li DF, Gao YL, Liu HC, et al. J Transl Med. 2020 Feb 28;18(1):106. doi: 10.1186/ s12967-020-02270-7.

Optimising paediatric patients’ long-term male reproduction Male-factor infertility is involved in 20% – 70% of couples struggling to conceive. Certain male paediatric developmental conditions, such as cryptorchidism, hypospadias, testicular and other childhood cancers, infections, and paediatric varicocele have been associated with future infertility. However, understanding the prospective impact of these conditions is challenging due to the delays between diagnosis, treatment, and reproductive age. Categorically, any condition affecting testicular function or causing testicular loss in childhood will have an impact on fertility. Testicular maldevelopment during foetal life may be a cause of infertility, together with common developmental and acquired conditions, such as testicular maldescent, torsion, cancer, and hypospadias, as represented by the definition of the testicular dysgenesis syndrome. Testicular dysfunction or loss can also be acquired from other cancers and their treatment, infections, and the development of a varicocele.

A recent – and first of its kind - systematic review (SR) and meta-analysis was undertaken to evaluate the efficacy and safety of thiazide diuretics to prevent new renal stones formation by pooling results of Spina bifida is a common form of congenital spinal randomised controlled trials (RCTs). dysfunction that may also affect fertility and sexual

Prof. Oliver Reich Section editor Munich (DE)

oliver.reich@ klinikum-muenchen.de function in affected patients. In addition, many boys are born with genetic disorders that have identifiable syndromes which may also affect fertility. In this review the authors discuss common childhood conditions that have been linked to male-factor infertility with emphasis on what could be done to preserve future fertility. Undescended testis (UDT) is the most common disorder of male sexual development and has a wide range of presentations, each with varying impacts on testicular development and function. Bilateral UDT is significantly associated with decreased paternity, whereas unilateral UDT is no different than control subjects. Although the optimal timing of orchidopexy is not fully clarified, there is strong evidence to suggest that early repair is advantageous to maximise fertility potential. The evidence behind the use of gonadotropins in children to optimise fertility is still weak. Currently, both the American and European urology associations recommend repair at the age of 6–18 months because decreased germ cells are observed histologically in longstanding mispositioned testes. Hypospadias, a common penile abnormality, also presents within a spectrum and may be linked to future infertility. Hypospadias may develop due to an underlying testicular dysfunction in utero, which may explain the link between hypospadias and infertility. Population-based studies have demonstrated a 13% – 21% reduction in the likelihood of fatherhood. Increasing severity of the hypospadias was associated with decreasing paternity rates. In case of paediatric cancer, the treatments for cancer may affect male fertility potential when chemotherapy or radiation is used or when the reproductive tissues are surgically removed. With increasing survival rates among paediatric oncology patients, it is crucial to fully inform patients and families about fertility preservation options as well as to consider treatment modifications if clinically acceptable. Proposed forms of pathophysiology causing increased infertility in testicular torsion include reperfusion injury by reactive oxidative species after an ischaemic event and autoimmunisation. Urgent urological evaluation and diagnosis followed by repair is the mainstay of preserving the testis.

The consensus is to perform early orchidopexy at 6-18 months to preserve future fertility potential of children with undescended testis. The prevalence of paediatric varicoceles is high and ranges from 4 to 35%. The mean age of presentation to the paediatric urologist office has been identified as 15.2 +/- 3 .5 years. Impact of a varicocele on subfertility is not well understood, because most men with varicoceles are fertile. The usual indications for intervention - although ultimately it is up to a clinician’s subjective judgement - include discrepant testicular sizes, testicular pain, and aberrant semen analysis parameters. Prospective trials are needed to clarify the ideal timing and type of treatment that offers boys the highest fertility potential during adulthood. The need of long-term follow-up is the main limitation. The potential impact on fertility and testicular and sexual function of a wide range of paediatric conditions necessitates early diagnosis and tailored treatments that have been shown to affect fertility outcomes. Despite all efforts there may still be increased rates of infertility and the need for assisted reproductive techniques.

Source: The pediatric patient and future fertility: optimizing long-term male reproductive health outcomes. Nassau DE, Chu KY, Blachman-Braun R, Castellan M, Ramasamy R. Fertil Steril. 2020 Mar;113(3):489-499. doi: 10.1016/j. fertnstert.2020.01.003. Review. PubMed PMID: 32192588.

EAU EU-ACME Office

European Urology Today

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EAU RF supports a new registry infrastructure Bridge between urological centres, research organisations, EAU Sections and Guidelines office Prof. Anders Bjartell Chairman, EAU Research Foundation Malmö (SE)

Prof. Arnulf Stenzl Adjunct Secretary General Executive Member Science, EAU Tübingen (DE)

Dr. Wim Witjes Scientific and Clinical Research Director, EAU Research Foundation Arnhem (NL)

anders.bjartell@ med.lu.se

Arnulf.Stenzl@med. uni-tuebingen.de

w.witjes@ uroweb.org

The mission of the EAU Research Foundation (EAU RF) is to promote, facilitate and stimulate clinical and basic research in European urology. We set out to achieve this mission by acting as a bridge between urological centres, research organisations and the EAU. We are working in close collaboration with the EAU Guidelines Office (EAU GO), the EAU Section Office and with other sections within the EAU to identify and fill gaps of knowledge in the field of urology. Today, there are many unmet needs in the field of urological research. At the same time, Europe as a platform, holds great potential for impactful investigations. In our vision, we strive towards a future, in which European urology research is abounding, relevant, high-quality, and yielded through a consolidated collaborative infrastructure. In order to achieve our mission, we have decided to further support collection of important clinical data and to build new registries to serve as platforms for work on relevant scientific questions. By building a platform of prospectively collected clinical information and real-world data we will meet the requirements of producing high-quality research. The next generation EAU Research Foundation

of electronic medical records will facilitate collection of clinical information and we need to be in the front-line of registry-based studies within the urological community.

behaviour of urothelial-variant histologies and non-urothelial histologies in muscle-invasive disease.

• Prospective registry on Renal Cell Carcinoma We have now implemented a new electronic database (RCC) following the RECUR database management system (Castor EDC). The system will be Proposed by the RECUR consortium, currently handled by one of our project managers within the including 15 sites in 9 European countries and EAU RF, Mrs. Joni Kats based at the EAU Central Office in Arnhem. The first three projects to be initiated are:

We Do

• eCORE COMET. Proposed by the EAU Section of Urolithiasis (EULIS) Project Investigator: Prof. Selcuk Guven, Istanbul (TR) Patient survey in patients with kidney stones to measure compliance to diet and/or medical treatment. Target is 1,000 patients in 15-20 centres.

with established RCC experts. Project Investigators: Prof. Axel Bex, London (GB), Dr. Saeed Dabestani, Malmö (SE) and Dr. Samra Turajlic, The Francis Crick Institute, London (GB). Novel molecular biomarkers will be evaluated in a clinical setting to see whether more accurate prognostication can be obtained both in the localised and metastatic settings of RCC. The second goal of a prospective registry would be to determine the best follow-up protocol according to established or novel risk stratification tools.

The projects will be described in detail in separate articles such as the one below. The EAU RF will consider additional proposals for new registries in the coming year. If you would like to get in touch with the EAU Research Foundation for any questions or suggestions, please send an e-mail to: researchfoundation@uroweb.org

Research

Stimulate, facilitate and conduct clinical research studies Stimulate, facilitate and conduct clinical registries

• Changing the future in bladder cancer variants: the EAU-BRaVeRY (BladdeR Variants RegistrY) Project Investigators: Dr. Andrea Necchi, Foundation IRCCS – National Tumour Institute, Milan and Dr. Andrea Gallina, San Raffaele Hospital, Milan (IT) Project manager: Dr. Filippo Pederzoli, Urological Research Institute, DiBit2, Scientific Institute San Raffaele, Milan (IT) A prospective, centralised, multicentre bladder cancer registry to study the prevalence and

Development of Good Registry Practices

Development of a European network of high quality urological research centres

Clinical Studies Clinical Registries

Basic Research

Development of a urological international research program Provide grants for fundamental innovative research Translational research

Changing the future of bladder cancer variants The EAU-BRaVeRY (BladdeR Variants RegistrY) platform will be launched in the coming months variant carcinoma when compared to upfront radical cystectomy, resulting in a higher rate of pathological downstaging to non-muscle-invasive disease and longer survival8. Promising data are also emerging from the immunotherapy setting, as recently reported in the PURE-01 study, which allowed the enrolment of patients with urothelial carcinoma and a predominant variant histology in its amended protocol9. Indeed, squamous cell carcinoma (SCC) and lymphoepithelioma-like (LEL) variant patients showed a remarkable sensitivity to immunotherapy, probably due to their enrichment in both high tumour Co-authors: M. Bandini, W. Witjes, A. Bjartell, mutational burden (TMB) and PD-L1 expression. A. Necchi Similar promising results come also from trials testing combination therapies in patients with advanced The therapeutic landscape of bladder cancer has never disease. A phase 2 study (NCT03333616), testing a been as promising as it is at this time. The encouraging combinatory regimen of nivolumab and ipilimumab, results from several trials testing immunotherapy or reported an objective response rate in one of four patients harbouring adenocarcinoma, and in two of six targeted therapy protocols for the metastatic and organ-confined1-3 disease would lead to historical patients with SCC10. Additional trials are currently open changes in the standard of care for bladder cancer in in the advanced setting for patients with histological the near future4,5, with a positive impact on the variant bladder cancer, and many will hopefully open survival and quality of life of affected patients. soon also in the bladder-confined disease.

further advance the knowledge in the field of bladder cancer, the EAU RF has created the EAU-BRaVeRY (BladdeR Variants RegistrY) protocol, a prospective, centralised, multicentre bladder cancer registry to study the prevalence, behaviour and patterns of care of urothelial-variant histologies and non-urothelial histologies in non-metastatic disease. The data collection will be undertaken from multiple centres in Europe, with no restriction on the number of patients enrolled per centre as long as they are consecutive. General patient inclusion criteria will be:

It is common knowledge that the majority of studies and trials focus on pure urothelial carcinoma6. However, over the last decade, research by pathologists have led to the characterisation and definition of several histological variants and differentiations of bladder cancer, which have been recently formalised and accurately described in the 2016 World Health Organization (WHO) classification of tumours in the urinary tract7. Histological variants are generally divided into urothelial and nonurothelial. These histological entities are present in up to 33% of cystectomy specimens, and they have been traditionally associated with an aggressive and poor response to treatment, although definitive evidence about their negative impact on survival is still lacking7. Moreover, the available – though limited – evidence on the biological and clinical behaviour of some of these entities suggest caution in generalising findings from one histology to all the others. For instance, neoadjuvant chemotherapy proved to be highly effective in patients with neuroendocrine small cell

The online platform will be launched over the next months and officially presented at EMUC 2020. With the creation of this multicentre registry, it will be possible to capture for the first time the therapeutic and surgical management of urothelial-variant histologies and non-urothelial histologies in a real-life setting. The EAU-BRaVeRY protocol will become a central tool for the development of evidence-based guidelines for the management of these rare entities.

Dr. Filippo Pederzoli Division of Experimental Oncology/Unit of Urology IRCCS San Raffaele Hospital Milan pederzoli.filippo@ hsr.it

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European Urology Today

It is clear that the available evidence is limited and sometimes conflicting, and controversies exist about the most appropriate management of patients with histological variant bladder cancer, resulting in substantial variations in real-life practice. Therefore, it is imperative to develop collaborative efforts to fill the gaps in knowledge and establish shared guidelines to standardise care. To this end, a huge effort by the European Association of Urology (EAU) and the European Society for Medical Oncology (ESMO) has recently led to the development of consensus statements on the management of advanced and variant bladder cancer11. From this, 71 statements reached consensus by a large, multidisciplinary group of experts in the field of bladder cancer. They will provide guidance to all health care professionals until the time when good-quality evidence will be available. Introducing the EAU-BRaVeRY protocol Since its foundation in 2007, the EAU Research Foundation (EAU RF) has designed and proactively carried out several projects to advance the knowledge of several urological conditions and to make a positive impact on patients’ quality of life. With the aim to

• the patient should be aged 18 years or older; • the patient should have a histological diagnosis of urothelial-variant or non-urothelial non-metastatic bladder cancer and should undergo surgical treatment +/- perioperative chemotherapy; • the patient is willing and able to give written informed consent for participation in the protocol. After initial entry, follow-up data will be collected yearly up to five years after the initial diagnosis of the histological variant.

References 1. Hussain SA, Birtle A, Crabb S, Huddart R, Small D, Summerhayes M, et al. From Clinical Trials to Real-life Clinical Practice: The Role of Immunotherapy with PD-1/ PD-L1 Inhibitors in Advanced Urothelial Carcinoma. Eur Urol Oncol 2018;1:486–500. https://doi.org/10.1016/j. euo.2018.05.011. 2. Pignot G, Loriot Y, Kamat AM, Shariat SF, Plimack ER. Effect of Immunotherapy on Local Treatment of Genitourinary Malignancies. Eur Urol Oncol 2019;2:355– 64. https://doi.org/10.1016/j.euo.2019.01.002. 3. Tripathi A, Grivas P. The utility of next generation sequencing in advanced urothelial carcinoma. Eur Urol Focus 2020;6:41–4. https://doi.org/10.1016/j.euf.2019.08.016.

4. Babjuk M, Burger M, Compérat E, Gontero P, Mostafid AH, Palou J, et al. EAU Guidelines on Non-muscle-invasive Bladder Cancer (TaT1 and CIS) 2018. European Association of Urology Guidelines. 2018 Edition, vol. presented at the EAU Annual Congress Copenhagen 2018, Arnhem, The Netherlands: European Association of Urology Guidelines Office; 2018. 5. Witjes JA, Bruins M, Compérat E, Cowan NC, Gakis G, Hernández V, et al. EAU Guidelines on Muscle-invasive and metastatic Bladder Cancer 2018. European Association of Urology Guidelines. 2018 Edition., vol. presented at the EAU Annual Congress Copenhagen 2018, Arnhem, The Netherlands: European Association of Urology Guidelines Office; 2018. 6. Vetterlein MW, Wankowicz SAM, Seisen T, Lander R, Löppenberg B, Chun FK-H, et al. Neoadjuvant chemotherapy prior to radical cystectomy for muscleinvasive bladder cancer with variant histology. Cancer 2017;123:4346–55. https://doi.org/10.1002/cncr.30907. 7. Humphrey PA, Moch H, Cubilla AL, Ulbright TM, Reuter VE. The 2016 WHO Classification of Tumours of the Urinary System and Male Genital Organs-Part B: Prostate and Bladder Tumours. Eur Urol 2016;70:106–19. https://doi. org/10.1016/j.eururo.2016.02.028. 8. Lynch SP, Shen Y, Kamat A, Grossman HB, Shah JB, Millikan RE, et al. Neoadjuvant chemotherapy in small cell urothelial cancer improves pathologic downstaging and long-term outcomes: results from a retrospective study at the MD Anderson Cancer Center. Eur Urol 2013;64:307–13. https://doi.org/10.1016/j. eururo.2012.04.020. 9. Necchi A, Raggi D, Gallina A, Madison R, Colecchia M, Lucianò R, et al. Updated Results of PURE-01 with Preliminary Activity of Neoadjuvant Pembrolizumab in Patients with Muscle-invasive Bladder Carcinoma with Variant Histologies. Eur Urol 2019. https://doi. org/10.1016/j.eururo.2019.10.026. 10. McGregor BA, Campbell MT, Xie W, Siefker-Radtke AO, Shah AY, Venkatesan AM, et al. Phase II study of nivolumab and ipilimumab for advanced bladder cancer of variant histologies (BCVH). JCO 2019;37:4518–4518. https://doi.org/10.1200/JCO.2019.37.15_suppl.4518. 11. Witjes JA, Babjuk M, Bellmunt J, Bruins HM, De Reijke TM, De Santis M, et al. EAU-ESMO Consensus Statements on the Management of Advanced and Variant Bladder Cancer—An International Collaborative Multistakeholder Effort†. European Urology 2020;77:223–50. https://doi. org/10.1016/j.eururo.2019.09.035.

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EAU RF studies on devices, instruments, disposables, etc. The MDR and why post-marketing clinical follow-up studies are needed Dr. Wim Witjes Scientific and Clinical Research Director, EAU Research Foundation Arnhem (NL) w.witjes@ uroweb.org EAU RF Urological Studies on devices, instruments, disposables and implants are subject to legislation, the 'Medical Device Regulation (MDR)'. This European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies selling their products in the European marketplace. Medical Device Regulation postponed for another year The new MDR entered into force on 25 May 2017, marking the start of the transition period for manufacturers selling medical devices in Europe1. The long awaited MDR text brings with it more scrutiny of technical documentation; it addresses concerns over the assessment of, not only, as it used to be, product safety, but also, and that is new, of performance for efficacy by placing stricter requirements on clinical evaluation and post-market clinical follow-up (PCMF), and requiring better traceability of moderate to high risk devices through the supply chain. Also, for some devices the classes they belonged to have been changed. The MDR, which replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), was originally planned to have a transition period of three years where after the MDR would be applicable on 25 May 2020. Due to the COVID-19 crisis the European Commission decided at the beginning of April 2020 to postpone the application date for one year to 25 may 2021 'in order to take the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the coronavirus crisis'. CE certification for medical devices Manufacturers gain market access in Europe when their device has obtained CE mark approval. CE stands for "Conformitée Européenne" and dictates the standards for CE certification. CE marking is the medical device manufacturer's claim that a product meets the essential requirements as described in the MDR. The MDR outlines the safety and performance requirements for certification of medical devices in the European Union (EU) for each of the device risk categories. There are safety and performance requirements in the pre certification phase of the medical device for all risk classes of devices as well as in the post-marketing clinical follow-up (PMCF) phase for devices with a moderate to high risk. Obtaining CE certification used to be focused on showing the safety of the device. This has changed in a way that the process for certification is now more similar to the process for obtaining approval to register a new drug for marketing. A CE marking is often incorrectly seen as a (quality) hallmark. In fact, a CE certification only implies a declaration of conformity of the medical device in question with the essential requirements such as those set forth in the Medical Device Dossier (MDD). Depending on the risk class, the CE marking is issued by the manufacturer himself (low risk classes) or by a Notified Body (higher risk classes). The CE marking applies to the ‘intended use’ of the medical device as defined by the manufacturer. The CE certificate is valid for the period as specified in the certificate, usually less than five years. On application by the manufacturer, the validity of the certificate may be extended for further periods, each EAU Research Foundation

March/May 2020

not exceeding five years, based on a re-assessment in accordance with the applicable conformity assessment procedures as described in the MDR. This entails a plan for a post-market surveillance system for each device of a manufacturer that is proportionate to the risk class and appropriate for the type of device. According to the MDR, such plans are part of the manufacturer's quality management system.

"Medical Device Regulation postponed for another year" For marketed devices, clinical evaluation and documentation of devices does not stop when a CE certification has been obtained. It continues throughout the life cycle of the device. The manufacturer’s post market surveillance system and its periodic safety updates and post-marketing clinical follow-up studies, developed to collect information from patients treated with devices, are important to show continued safety and efficacy of the device. MDR definitions The most important definitions relevant for urologists are: A 'surgically invasive device' is defined as a device which penetrates inside the body through the surface of the body, including through mucous membranes of body orifices with the aid or in the context of a surgical operation; or a device which produces penetration other than through a body orifice. ‘Transient’ means normally intended for continuous use for less than 60 minutes. ‘Short term’ means normally intended for continuous use for between 60 minutes and 30 days. ‘Long term’ means normally intended for continuous use for more than 30 days. ‘Reusable surgical instrument’ means an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out. ‘Active therapeutic device’ means any active device used, whether alone or in combination with other devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or disability. ‘Active device intended for diagnosis and monitoring’ means any active device used, whether alone or in combination with other devices, to supply information for detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities. Specification of the risk classes of Urological Devices according to the MDR

The text below describes the risk class per type of device and is a selection from the MDR with a focus on diseases, treatments and cures for patients with urological diseases. It is apparent that devices used in urological disciplines are represented in all risk classes. • The risk class of non-invasive devices The following MDR rules apply to this group of devices: Rule 1: All non-invasive devices are classified as class I, unless one of the MDR rules 2-4 apply apply1. Rule 2: All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa: • if they may be connected to a class IIa, class IIb or class III active device; or • if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb. In all other cases, such devices are classified as class I. Rule 3: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa. All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.

"At EAU RF, we have launched several PMCF registries studying patients who received CE marketed devices for their incontinence and erectile dysfunction (ED) ..." Rule 4: All non-invasive devices which come into contact with injured skin or mucous membrane are classified as: • class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates; • class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or mucous membrane and can only heal by secondary intent; • class IIa if they are principally intended to manage the micro-environment of injured skin or mucous membrane; and • class IIa in all other cases.

• Three risk classes of medical devices The following 3 risk classes are distinguished:

This rule 4 applies also to the invasive devices that come into contact with injured mucous membrane.

Class I medical devices: Approximately 47% of medical devices fall under this category. These devices usually sustain or support life, or present potential unreasonable risk of illness or injury. Class I devices are those devices with low to moderate risk to the patient or user.

• The risk class of invasive devices The following MDR rules apply to this group of devices: Rule 5: All invasive devices with respect to body orifices, other than surgically invasive devices, which are not intended for connection to an active device or which are intended for connection to a class I active device are classified as:

Class II medical devices: Approximately 43% of medical devices fall under this category. Class II devices are devices with a moderate to high risk to the patient or user. Examples are pregnancy test kits and • class I if they are intended for transient use; urethral catheters. • class IIa if they are intended for short-term use, except if they are used in the oral cavity as far as Class III medical devices: Examples of Class III devices the pharynx, in an ear canal up to the ear drum include, implantable pacemakers, breast implants, or in the nasal cavity, in which case they are slings, artificial urethral sfincters, penile implants. classified as class I; and Approximately 10% of medical devices fall under this • class IIb if they are intended for long-term use, category. Class III devices have a high risk to the except if they are used in the oral cavity as far as patient or user. the pharynx, in an ear canal up to the ear drum

or in the nasal cavity and are not liable to be absorbed by the mucous membrane, in which case they are classified as class IIa. • All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to a class IIa, class IIb or class III active device, are classified as class IIa. Rule 6: All surgically invasive devices intended for transient use are classified as class IIa unless they: • are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body, in which case they are classified as class III; • are reusable surgical instruments, in which case they are classified as class I; • are intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system, in which case they are classified as class III; • are intended to supply energy in the form of ionising radiation in which case they are classified as class IIb; • have a biological effect or are wholly or mainly absorbed in which case they are classified as class IIb; or • are intended to administer medicinal products by means of a delivery system, if such administration of a medicinal product is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are classified as class IIb. Rule 7: All surgically invasive devices intended for short-term use are classified as class IIa unless they: • are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body, in which case they are classified as class III; • are intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system, in which case they are classified as class III; • are intended to supply energy in the form of ionizing radiation in which case they are classified as class IIb; • have a biological effect or are wholly or mainly absorbed in which case they are classified as class III; • are intended to undergo chemical change in the body in which case they are classified as class IIb, except if the devices are placed in the teeth; or • are intended to administer medicines, in which case they are classified as class IIb. Rule 8: All implantable devices and long-term surgically invasive devices are classified as class IIb unless they: • are intended to be placed in the teeth, in which case they are classified as class IIa; • are intended to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are classified as class III; • have a biological effect or are wholly or mainly absorbed, in which case they are classified as class III; • are intended to undergo chemical change in the body in which case they are classified as class III, except if the devices are placed in the teeth; • are intended to administer medicinal products, in which case they are classified as class III;

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Types of Medical Device Studies depend on the aims of the studies. For CE marketing studies, these are studies to obtain CE marketing for a new or changed medical device, randomised or nonrandomised clinical trials can be used whereas for PMCF studies, both registries and clinical trials can be used. For an overview how to set up a registry, see reading guide 'Starting a registry study' from B. Kiemeney (2019) (www.uroweb.org/research/ how-we-work)2.

Continued from page 13

• are active implantable devices or their accessories, in which cases they are classified as class III; • are breast implants or surgical meshes, in which cases they are classified as class III; • are total or partial joint replacements, in which case they are classified as class III, with the exception of ancillary components such as screws, wedges, plates and instruments; or • are spinal disc replacement implants or are implantable devices that come into contact with the spinal column, in which case they are classified as class III with the exception of components such as screws, wedges, plates and instruments. • The risk class of active devices The following MDR rules apply to this group of devices: Rule 9: All active therapeutic devices intended to administer or exchange energy are classified as class IIa unless their characteristics are such that they may administer energy to or exchange energy with the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy, in which case they are classified as class IIb. All active devices intended to control or monitor the performance of active therapeutic class IIb devices, or intended directly to influence the performance of such devices are classified as class IIb. All active devices intended to emit ionizing radiation for therapeutic purposes, including devices which control or monitor such devices, or which directly influence their performance, are classified as class IIb. All active devices that are intended for controlling, monitoring or directly influencing the performance of active implantable devices are classified as class III. Rule 10: Active devices intended for diagnosis and monitoring are classified as class IIa:

• if they are intended to supply energy which will be absorbed by the human body, except for devices intended to illuminate the patient's body, in the visible spectrum, in which case they are classified as class I; • if they are intended to image in vivo distribution of radiopharmaceuticals; or • if they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless they are specifically intended for monitoring of vital physiological parameters and the nature of variations of those parameters is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of the central nervous system, or they are intended for diagnosis in clinical situations where the patient is in immediate danger, in which cases they are classified as class IIb. Active devices intended to emit ionizing radiation and intended for diagnostic or therapeutic radiology, including interventional radiology devices and devices which control or monitor such devices, or which directly influence their performance, are classified as class IIb. Rule 11: Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:

• death or an irreversible deterioration of a person's state of health, in which case it is in class III; or • a serious deterioration of a person's state of health or a surgical intervention, in which case it is classified as class IIb.

At EAU RF, we have launched several PMCF registries studying patients who received CE marketed devices for their incontinence and erectile dysfunction (ED)3. These registries are designed together with expert urologists on incontinence and ED to collect big data from daily practice to evaluate the cure rate and other clinical outcomes of medical device procedures for treatment of incontinence and ED. Such big clinical data enables us to identify patient factors and clinical / surgical variables that correlate with best practice which helps us to improve clinical urological practice and guidelines.

According to the MDR, PMCF registries or trials should be used to support a claim from the manufacturer for Software intended to monitor physiological processes the entire duration of the life span of a CE marketed device. For example, the cure rate of a disease after is classified as class IIa, except if it is intended for treatment with a CE marketed device and the monitoring of vital physiological parameters, where applicable patient population are familiar. To design the nature of variations of those parameters is such that it could result in immediate danger to the patient, an appropriate PMCF study, the aim of the study can be accurately assessed and with methodological in which case it is classified as class IIb. calculations, a sample size can be calculated to show if a claim for e.g. efficacy or safety of the device can All other software is classified as class I. still be supported, or even improved in specific categories of patients. Rule 12: All active devices intended to administer and/or remove medicinal products, body liquids or other substances to or from the body are classified as More information class IIa, unless this is done in a manner that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body For more information please contact: concerned and of the mode of application in which Wim P.J. Witjes, MD, PhD at EAU RF: case they are classified as class IIb. w.witjes@uroweb.org

Rule 13: All other active devices are classified as class I. Medical device studies carried out by the EAU RF Medical device studies carried out by the EAU RF

References 1. https://eur-lex.europa.eu/legal-content/EN/TXT/ PDF/?uri=CELEX:32017R0745&qid= 1579597933289&from=EN 2. https://uroweb.org/research/how-we-work/ 3. https://uroweb.org/research/projects/

Viorel Bucuras Excellent surgeon, teacher, and scientist leaves huge gap in urologic community 1959 - 2020

Not only left Viorel a tremendous mark on European urology, he also had an essential influence on Romanian urology. For instance, he was a member of the directors board of the Romanian Association of Urology since 1999 and was one of the founding members of the Romanian Association of Endourology. He was loyal to Timisoara, where he spent most of his professional life. After long and hard suffering, our friend and colleague Prof. Viorel Bucuras left this world on 11 January 2020. Viorel was an excellent surgeon, teacher, and scientist with special interest in minimally invasive therapy in urology.

Prof. Günter Janetschek (AT) and Prof. Viorel Bucuras during an ESUT live surgery session in Stockholm at EAU 2009

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European Urology Today

Born on 21 March 1959 in Brașov, Romania, Viorel graduated from the Faculty of Medicine at the Victor Babes University in Timisoara (RO) in 1986. Before he did his doctoral thesis at the Karl Ruprecht University in Heidelberg (DE) in 1995, he was first a medical doctor, then a resident in urology at the Timisoara University Hospital. In 1998, he became a consultant urologist. Viorel was highly skilled in urological laparoscopy, and he performed over 700 procedures of percutaneous nephrolitholapaxy and over 300 procedures of ureteroscopy, among other things.

His orderly and effective way of working was reflected in his university activities. He started as an assistant professor at the Department of Urology of the Timisoara University of Medicine and Pharmacy in 1990 and worked his way up without ever leaving, being appointed professor and chairman of the department in 2008. A determined innovator, Viorel became a board member of the EAU Section of Uro-technology (ESUT) in 2007, and five years later he was appointed chairman of the Training Group of ESUT. During this time, we all enjoyed his activities; in particular the well-organised laparoscopic training programme at the Victor Babes University. Viorel also actively participated in the various ESUT live surgery sessions during the annual EAU congresses (see photo).

All of us were also impressed by the social events Viorel organised. He celebrated with us at the Recas winery in Timisoara, with a lot of excellent wines and music, and he invited us to go on hunting excursions in the Transylvania woods. Hunting was one of Viorel’s hobbies, just like sports, literature, and travelling. Viorel leaves a huge gap in the Romanian and European urologic community. He will be missed. Prof. Jens Rassweiler, Prof. Evangelos Liatsikos, Prof. Ali Serdar Gözen, Assoc. Prof. Bogdan Petrut On behalf of the EAU Section of Uro-technology (ESUT)

March/May 2020


Introducing European Urology Open Science Fourth member of the EU Family to offer free-to-access, peer-reviewed, high-quality content By Loek Keizer European Urology Open Science published its first papers in January 2020. It is part of the recent expansion of the EU family with EU Focus (2015) and EU Oncology (2018). We spoke to European Urology Editor-in-Chief Prof. James Catto (GB) about the journal’s plans for the new online edition. Prof. Catto heads up this new edition together with Prof. Jochen Walz (FR) as co-editors in chief.

“We hope it will complement the other EU journals by offering a broader appeal, open access publication and slightly higher acceptance rates.”

“The content will be urological in nature, peer-reviewed, proof-edited and we will aim for

Prof. Jochen Walz

high quality. We will try to cover the broad spectrum of our specialty and deliver meaningful, practice-changing research or clinical audits. We will have video content, case series with a purpose, trial protocols and up-to-date reviews with CME credits. We hope it will complement the other EU journals by offering a broader appeal, open access publication and slightly higher acceptance rates.”

family beyond our current readers. Hopefully it will educate this new generation of readers that work published in the European Urology family of journals is of high quality, interesting, useful and of high scientific rigor. We see it as a mark of quality to be published in one of our journals.”

s es cc A

Despite the unique nature of this edition, the EAU’s ambition for this journal are similar to that for the EU family as a whole. “Our mission statement is to use education and research to improve the care of our patients worldwide,” says Catto. “All of our journals work towards this mission. Open Science will help in an open access format that is more accessible than EU, EU Focus or EU Oncology.”

Prof. James Catto

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“The world of publishing is changing,” according to Prof. Catto. “This is true in medical publishing as much as other forms of publishing. As such, there is a demand for online open-access content driven by readers, funders of research and patients. We have therefore launched an open access member of the European Urology family called European Urology Open Science. As the name indicates, the journal is 100% open access and publishes high-quality science for all clinicians caring for urological patients.”

European Urology Open Science Aims and Scope

Changes in publishing The editorial process behind the content of European Urology Open Science comparable to all EU family journals, with one notable difference. Prof. Catto: “In contrast to the other journals, the costs for publishing will sit with the author rather than the reader. This is in line with Plan S, an initiative with wide support, including from the European Commission.” “Open Science is placed to adopt, embrace, and adapt new publishing models. We know that urologists are early adopters, whether that be with robotic surgery or Twitter, and so they will embrace the new delivery of this journal. We hope Open Science will keep our speciality at the forefront of publishing.” As European Urology content becomes free to read, Prof. Catto sees opportunities for a new audience: “Given the changing nature of publishing, we hope Open Science will broaden the attraction for the EU

Editors in Chief:

European Urology Open Science is the Open Access journal of the European Urology family. It is dedicated to the publication of high-quality, innovative research that will benefit patients with urological conditions, in keeping with the mission of the European Urology family. European Urology Open Science covers all kinds of research in the urological field, including clinical, basic and translational research. European Urology Open Science reflects the evolving publishing model so all published papers will have unrestricted access and be published online-only. “Accessible for all” articles published in European Urology Open Science will include original articles, review articles, study protocols, case reports, video articles, brief correspondences, European Board of Urology (EBU) Update Series, EAU-guidelines Updates and European Urology Supplements. All articles are peer reviewed by a panel of dedicated experts and proof read by copy editors. European Urology Open Science articles are indexed in Web of Science and the Science Citation Index.

Related publications:

European Urology Open Science is the perfect publication vehicle for the proceedings of a scientific symposium. European Urology Open Science publishes the European Urology Supplements (ISSN 1569-9056) and the EAU-EBU Update Series (ISSN 1871-2592).

James Catto Jochen Walz

EU Open Science joins European Urology, EU Focus and EU Oncology

Introducing European Urology Open Science

We are pleased to announce the launch of European Urology Open Science, a member of the European Urology family of journals. The journal is dedicated to the publication of high quality, innovative research that will benefit patients with urological conditions and will serve the world-wide community of urologists in academia and practice. European Urology Open Science is a broad-scope, gold open access (OA) journal published on behalf of the European

Association of Urology (EAU) and the European Board of Urology (EBU). All OA articles will be immediately and permanently accessible online-only for everyone to read, download, copy and distribute. Learn more about OA https://www.elsevier.com/journals/europeanurology-open-science/open-access-journal Submit your paper https://www.editorialmanager.com/euros

@EUopenscience eu-openscience.europeanurology.com

March/May 2020

European Urology Today

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Historical highlights from urology in the Netherlands From Golden Age uroscopy to twentieth-century anatomical discoveries Unfortunately, with the postponement and the cancellation of EAU20 in Amsterdam, the History Office cannot hold its annual Historical Exhibition as intended. We would nevertheless like to share with you some of the contents of the exhibition and the accompanying brochure, in the hope that you get a flavour of the history of Dutch urology. What follows is a selection, by no means a complete history, of urological topics related to Amsterdam and the Netherlands. Special thanks to long-time History Office member Dr. Erik Felderhof (Hoofddorp, NL) for compiling this information. Haarlem Oil As in many countries in Western Europe, until the end of the 19th century urological problems in the Netherlands were treated by medical professionals with different levels of education or interests. Surgery was performed in the early days by traveling barber surgeons, often belonging to one family who trained their successors in the “cutting of the (bladder) stone”. Non-surgical treatment was managed by apothecaries or physicians, sometimes educated at a medical school (a university in the Netherlands or abroad), mainly with natural local herbal products.

Figure 5: Pieter Donker (1914-1999)

A special, world-famous Dutch medicine used and prescribed for urinary stone disease and urinary infections was called “Haarlemmer Olie”(Haarlem Oil), a mixture of turpentine oil (from pine trees), sulphur and herbs. (Figure 1) This medication was used all over the world for more than 300 years and is still produced in Haarlem, a town 20 kilometres west of Amsterdam. Uroscopy Uroscopy was one of the urological skills that belonged to the medical profession. It was based on the “four humors” theory of Galen, a doctor living around the second century AD in the Roman Empire. If one of the four “humors” was misbalanced, illnesses would occur. Between the 9th and 11th centuries, a scheme was developed (Figure 2) to investigate urine in a urine glass, called a matula. The matula is probably the oldest, and first, urologic diagnostic instrument; it was still in use until the 19th century. The house of a “medical professional” could often be recognised by the sign of a matula hanging outside the front door. By the mid-19th century, when other chemical analyses could be done on urine and were more accurate, uroscopy was abandoned by urologists. From that time on uroscopy was only done by quacks, a practice that continues even to this day.

Figure 1: A selection of Tilly Haarlem Oil

Figure 3: Doctor and a love-sick woman (1697) painted by the Dutch artist Richard Brakenburgh (1650-1702)

Already in the 17th and 18th century many “healers” who were not educated at a medical school were charged with fraud and depicted on paintings of the Golden Age. Figure 3 shows a doctor and a love-sick woman, a beloved theme in the 17th century, painted by the Dutch artist Richard Brakenburgh (1650 - 1702) in 1697. This painting belonged to the collection of books and instruments of the late Dutch paediatric urologist Jos De Vries (1944 - 1996) and was acquired by the EAU History Office several years ago.

his work at the anatomical lab. As a host, Donker wanted to show Walsh around Leiden, but Walsh was more interested in working at the lab. Donker Figure 6: Patrick Walsh (1938-)

and Walsh dissected the body of a stillborn boy to explore the anatomy of the small pelvis. At that time, radical prostatectomy was not frequently performed for the radical treatment of prostate cancer because the postoperative complications of impotence and urinary incontinence. Mostly, men were treated by external radiotherapy. Walsh wanted to improve the operation technique by saving the innervation and sphincter muscle. Based on these discussions, Patrick Walsh became world-famous with his first nervesparing radical prostatectomy. Even after 25 years the first patient kept his potency and was fully continent.

In the same period a “doctor” would be depicted as a cheat who asked money for his advice based on fantasy. This can be seen in De Piskijker (“the uroscopist”, literally, “the piss looker”) c.1663) by well-known Dutch artist Jan Steen (1626-1679). He depicts a doctor, who could not even put his own shoes on properly (they are switched) and who was visiting a clearly visible pregnant woman, examining her urine in a matula. The two matulas that were to be on display at the Historical Exhibition were found in archeologic excavations during the development of the Amsterdam metro system over the past fifty years. One is in a very sound condition and is probably 300 years old. (Figure 4) It was found in 1974 near the Nieuwmarkt (“new market”) with its impressive old Waag or weighing house. A significant number of the houses in this antique old town and early harbour were torn down for the building of the east line of the metro, which led to many violent protests of students and local inhabitants.

Figure 4: The pristine ”Nieuwmarkt matula” that was found in 1974, probably from the 17th century

The sketches and illustrations that would have been reproduced at the History Office exhibit (Figure 7) were found after the retirement of Donker, when the attic of the former urology department had to be cleaned before the destruction of the building took place.

The other matula was found in the muddy soil when the North-South metro line was built in the first decades of the 21st century. Donker and Walsh A more recent chapter in Dutch contributions to urology can be found in the story of two pioneers who made nerve-sparing radical prostatectomy.

Figure 2: An example of a uroscopy wheel, with different ailments assigned to different colours of urine EAU History office

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European Urology Today

At the University Clinic in Leiden, Professor Pieter Donker (1914-1999) ran an experimental and anatomical laboratory and was especially interested in the (micro-)anatomy of the intrapelvic organs. During a visit to the AUA in Baltimore in 1981, Donker and his wife met Dr. Patrick Walsh (1938-) of Johns Hopkins, who also was investigating the blood supply and innervation of the cavernous corpora. (Figures 5 and 6) In a discussion over dinner, Walsh found out that Pieter Donker had the same interest and Donker invited him to Leiden and showed him

Figure 7: One of the illustrations that was originally featured (in black and white) in the seminal 1982 article in the Journal of Urology by Walsh and Donker. (Photo courtesy of Rob Pelger)

March/May 2020


ESU Update

ESU-ESUT Masterclass on Urolithiasis goes virtual Changes in the programme and what to look forward to By Erika De Groot In the past months, the COVID-19 pandemic has evolved into an unimaginable health crisis with repercussions on a global scale. It has influenced the way we live, the way we work, and the way we connect. Adaptation is key and at present, becomes a necessity. The European Association of Urology (EAU) and the European School of Urology (ESU) have modified its events and activities to keep the knowledge-exchange going. One of these events is the much-awaited ESU-ESUT Masterclass on Urolithiasis. This year, the masterclass’ faculty and organisers have opted for a virtual masterclass, a safer and accessible alternative designed to preserve the quality of its scientific programme. Virtual events such as this transcend restrictions of in-person events. A participant from anywhere in the world can join, given he/she has online access. The masterclass will retain its well-rounded programme which the ESU and the EAU Section of Uro-Technology (ESUT) have developed together. Prof. Evangelos Liatsikos (GR), one of the esteemed

faculty members of the masterclass, stated “Education, the progress of the urological field, and improvement of daily clinical practice will not be put to a halt. We adjust, we adapt and we forge on. The virtual masterclass will keep its classroom format through a video-conference setup with 40 to 50 participants from all over the world. The interaction is instantaneous; when a participant has a question, a faculty member can provide answers and insights in real-time.” The scientific programme will still comprise of the always anticipated live and semi-live surgeries. Leading urologists will demonstrate procedures such as supine endoscopic combined intrarenal surgery (ECIRS), prone percutaneous nephrolithotripsy (PCNL), flexible ureteroscopic lithotripsy, and single-use ureteroscopic lithotripsy. “During the live and semi-surgeries, the designated surgeons will describe the procedures, techniques, and equipment information in detail. These surgeries will either be live-streamed or prerecorded in advance. Participating facilities will include my hospital, the General University Hospital of Patras, and other fine European institutions,” explained Prof. Liatsikos.

As an alternative for the hands-on training, Prof. Liatsikos stated that more esteemed experts will join the faculty which will further enrich the scientific programme and online deliberations. When asked what highlights participants can look forward to, Prof. Liatsikos answered, “There are no distinguishable highlights because the masterclass itself is the highlight with its richer content and its new format”.

and diverse lectures on PCNL tips and tricks; single-use scopes for endourology; various puncture techniques; PCNL and ureteroscopy strategies for challenging cases; and a panel discussion on the endourological complications.

“Every monumental crisis, such as the current pandemic, will cause problems and create obstacles. However in these same crises lie opportunities for Masterclass coverage growth. We can flourish in the new way of living. In Day one will commence on 19 June and comprise of education for instance, there is the creation of novel live surgeries demonstrating supine ECIRS, prone methods of teaching. The masterclass is an example PCNL, flexible and single-use ureteroscopic lithotripsy, of that. Virtual and/or hybrid events have found its along with pre-recorded surgeries on flexible place in the new world of education and will continue ureteroscopic lithotripsy and bladder stone lithotripsy. as a legitimate alternative to face-to-face interaction even after the pandemic,” concludes Prof. Liatskios. Key opinion leaders will also offer insights during their presentations on shock wave lithotripsy; About the masterclass metabolic evaluation as conservative management of An application has been made for accreditation of this urolithiasis; PCNL and mini PCNL; medical expulsion masterclass at the European Accreditation Council for therapy; grounds for use of access sheaths; semiContinuing Medical Education (EACCME). rigid ureteroscopy; lasers; pressures and temperatures during endourological procedures. More information will soon be published on the masterclass' website. Read the reviews of previous Day two will consist of a pre-recorded surgery participants and explore the scientific programme, illustrating single-use flexible ureteroscopic lithotripsy, please visit www.esuurolithiasis20.org.

ESU-ESUT Masterclass on Urolithiasis

VIRTUAL 19-20 June 2020

www.esuurolithiasis20.org

EAU Edu Platform The online learning platform for GU cancers

www.esuerectile20.org

ESU-ESAU-ESGURS Masterclass on Erectile restoration and Peyronie’s disease 1-2 October 2020, Leuven, Belgium

PROSTATE CANCER

An application has been made to the EACCME® for CME accreditation of this event

KIDNEY CANCER

BLADDER CANCER

uroonco.uroweb.org Powered by

March/May 2020

European Urology Today

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New activity

ESU-ESUI Masterclass on Prostate Biopsy Optimisation to improve diagnosis and prevent overtreatment How should we perform prostate biopsy for optimal results? How do magnetic resonance imaging (MRI) and MRI fusion-guided biopsies improve diagnosis and at the same time prevent overtreatment and overdiagnosis? What are the advantages and limitations? The European School of Urology (ESU) and the EAU Section of Urological Imaging (ESUI) developed the ESU-ESUI Masterclass on Prostate Biopsy to enrich the proficiencies of urologists in these procedures. The first edition of the masterclass will take place in Marseille, France from 26 to 27 November 2020 under the guidance of renowned experts Dr. Lars Budäus, Prof. Georg Salomon (DE), and Dr. Jochen Walz (FR).

standardised reading and reporting; and what is involved with the quality control for MRI and the costs. Day one will conclude with lectures on antibiotics, transperineal and transrectal approaches, and the second phase of case interpretations using the workstations.

"In-depth understanding of the potential and limitations of MRI targeted and randomised biopsy is crucial to fine-tune prostate-cancer diagnosis in daily clinical practice..."

biopsies and applications on different clinical scenarios. The participants will familiarise themselves first-hand during the Hands-on workshop systematic and fusion biopsy: How to hit the target. The workshop will take place twice to provide participants time to partake in all activities involved.” The masterclass participants will know more about factors to consider in starting a fusion biopsy service; and how to handle, process, and report prostate-biopsy specimens.

The Scientific Programme will also include highly-informative video sessions that demonstrate various forms of navigation (e.g. What to expect on day one cognitive, electromagnetic, Day-two coverage As prostate biopsy is the current mainstay of image-based, mechanical, and The ESU-ESUI masterclass will expound upon the prostate-cancer diagnosis, and MRI is increasingly technical features and limitations of MRI targeted and robotic); must-know data on risk used in patients undergoing prostate biopsies, day one of the masterclass will commence with the basics randomised biopsy. Participants will also receive vital stratification based on targeted insights on how to get the most of randomised biopsy, biopsies; and deliberations on in prostate anatomy, ultrasound and MRI. Thereafter, how to use the procured the participants will train in MRI reading by reviewing as well as, the basics in essentials in fusion biopsy. information from prostate biopsy. patient cases. “In-depth understanding of the potential and limitations of MRI targeted and randomised biopsy is To conclude the masterclass, As MRI interpretation as a urological activity is a crucial to fine-tune prostate-cancer diagnosis in daily faculty members will also share growing necessity in prostate-cancer diagnosis, the their expertise with links and clinical practice. Moreover, various MRI-ultrasound participants will have the opportunity to apply their topic coverage on surgery, fusion devices allow integration of MRI information newfound knowledge on MRI reading through into the daily workflow of transrectal or transperineal radiotherapy, focal therapy and interactive case interpretations behind workstations. prostate biopsies which will play an increasing role in active surveillance. the future,” stated Dr. Walz. The first day of the masterclass will proceed with How to apply to this masterclass deliberations on the relevance of early detection and The criteria for admission to the According to Dr. Budäus, MRI interpretation and MRI screening for prostate cancer; enumeration of the masterclass include: fusion-guided biopsies help reduce overtreatment indications for prostate biopsy; and identification of • You must be an EAU member and overdiagnosis. “Profound knowledge of the diagnostic biomarkers. underlying technical aspects are important. We aim to • You must be a certified urologist Participants will also learn more about the distinction provide an overview of various technical approaches, their benefits and shortcomings. The masterclass will • You must be 40 years old or between PI-RADS (Prostate Imaging-Reporting and younger Data System) Version 2 and the Likert scale in terms of also offer insights on the advantages of MRI fusion

www.esulasers20.org

The deadline for application is 14 September 2020. For more information, please contact ESU Manager Mrs. Jacobijn Sedelaar-Maaskant or Project Coordinator Ms. Sophie Mills via esu@uroweb.org.

www.esu-masterclasses.org

ESU-ESUI Masterclass on Prostate Biopsy 26-27 November 2020, Marseille, France An application has been made to the EACCME® for CME accreditation of this event

www.artinflexible.uroweb.org

ESU-ESUT Masterclass on Lasers in urology 19-20 November 2020, Barcelona, Spain An application has been made to the EACCME® for CME accreditation of this event

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European Urology Today

2-4 December 2020, Berlin, Germany

March/May 2020


ESU Updates

Let’s get digital: e-courses, webinars and Edu platforms ESU provides e-learning in the time of the pandemic By Erika De Groot

The first e-course, the “Basis of ADT”, is now accessible online via www.uroweb.org/course/ “Social distancing”, “quarantine”, and “lockdown” advanced-prostate-cancer-basis-of-androgenare words we have come to know so well in recent deprivation-therapy/. This e-course consists of three months. In the time of a global health crisis, we have chapters: “Androgen Bio-synthesis”, “Androgen adapted digital alternatives in lieu of face-to-face and Deprivation Therapy” and “Adverse Events and Side tactile interaction. Effects.” Upon completion, you will receive 1 CME credit and a downloadable certificate. In education, the European School of Urology (ESU) recognises that e-learning is currently the best and safest option we have. Unrestricted by time zones and venues, the ESU turns the virtual world into a classroom by offering numerous activities which include free e-courses, webinars and collaborative initiatives such as the EAU Edu Platforms. Test your knowledge with e-courses ESU e-courses are known for their top-of-the-line content and comprehensive coverage on urolithiasis, men’s health, chronic pelvic pain, renal cancer, and many more. In line with the newest EAU Guidelines and developed by highly-experienced urologists, the e-courses are designed to test and boost your knowledge. Each e-course is accredited by the European Accreditation Council for Continuing Medical Education (EACCME) with European CME credits (ECMEC®). The latest addition to ESU’s e-courses is the series “Advanced Prostate Cancer” which was developed under the guidance and expertise of Chair of the EAU PCa Guidelines Panel Prof. Nicolas Mottet (FR). The series provides information on diagnostic tools, prognosis and predictive factors, patient stratification, and treatment options. Comprised of five e-courses, the series is focused on androgen deprivation therapy (ADT), metastatic PCa (mPCa), non-metastatic prostate cancer (nmPCa), metastatic castration-resistant prostate cancer (mCRPC) and non-metastatic castration-resistant prostate cancer (nmCRPC).

Test your ADT knowledge now and receive your CME credit

Get timely expert insights via webinars Receive the latest updates on a myriad of urological topics straight from the key opinion leaders themselves. Whether you are a junior or a seasoned urologist, you will benefit from the ESU webinars. You can expect informative presentations and ample opportunities for you to ask your questions and share your opinions. All ESU webinars are recorded so you can re-access them at your own convenience. Explore the webinars now via www.uroweb.org/education/onlineeducation/webinars. Some of the most recent webinars include the following: • In “COVID-19 recommendations for oncourologists”, Mr. Philip Cornford (GB) and Prof. Alfred Witjes (NL) discussed the unmet needs of onco-urologists and addressed sought for better management of the COVID-19 situation.

• In “Diagnostic Evaluation & Management of Male Infertility”, Mr. Kamran Ahmed (GB) underscored male infertility and talked about its aetiology, diagnosis and management. • In “COVID-19 and urological management of stone disease”, Dr. Silvia Proietti (IT) and Prof. Florian Wagenlehner (DE) addressed limitations, issues faced, epidemiology, and priorities of stone treatment in the time of the pandemic. • In “Evolving interventional therapy for bladder outlet obstruction in men: Where do we stand?”, Dr. Fernando Gomez Sancha (ES) provided an overview on more modern alternatives of treatment options for lower urinary tract symptoms (LUTS) suggestive of benign prostatic obstruction (BPO). Valued resources: EAU Edu Platforms The EAU Edu Platforms highlight the best-curated content in various fields of urology varying from the latest clinical trial findings, meeting reports, to in-depth interviews with experts. These platforms are an initiative by the European Association of Urology in collaboration with the ESU and European Urology journal. The two main educational platforms are UROONCO and UROLUTS. UROONCO offers relevant developments in the field of urological malignancies. This platform is comprised of three topics: “Prostate Cancer”, “Bladder Cancer”, and “Kidney Cancer”. To know more about UROONCO, please visit uroonco.uroweb.org. The UROLUTS platform provides the latest LUTS information and covers three topics such as “Male LUTS”, “Bedwetting” and “Nocturia”. Feel free to explore the UROLUTS platform via uroluts.uroweb.org.

Each topic from the UROONCO and UROLUTS platforms is selected by a team of expert editors to give you vital insights from clinical trials, publications, abstracts and educational ESU activities such as webinars, e-courses and masterclasses.

One of the recent COVID-19 webinars

First ESU virtual masterclass Speaking of masterclasses, the upcoming ESU-ESUT Masterclass on Urolithiasis, which will take place from 19 to 20 June, is the first ESU masterclass to go virtual. The masterclass will keep its classroom format through a videoconference setup and will stream numerous live surgeries as part of its programme. To know more, please go to page 17. “Green” repercussions Aside from time-independency, accessibility and being cost-free, another notable advantage of going virtual is the eco-friendliness. No travel, hotel stays and printouts necessary. All you need is your desktop computer, laptop or mobile and a good internet connection. To know more about the ESU and its online activities, please visit www.uroweb.org/education/onlineeducation.

EAU Edu Platform

Education Online

The online learning platform for Lower Urinary Tract Symptoms

e-learning at your own convenience

EAU Education Online course

Advanced Prostate Cancer: Basis of Androgen Deprivation Therapy (ADT) The first course in the Advanced Prostate Cancer series The new Advanced Prosate Cancer series is comprised of 5 courses which offer clinicians a complete view on clinical aspects, diagnosis and treatments of prostate cancer.

Learning chapters in Basis of ADT: Chapter 1: Androgen Bio-synthesis Chapter 2: Androgen Deprivation Therapy (ADT) Chapter 3: Adverse Events and Side Effects Prof. Nicolas Mottet Main Coordinator CHU St Etienne, Department of Urology, Saint-Étienne (France)

1 CME c

redit

Free access with MyEAU account

This course is in line with the EAU Guidelines 2020. This course is supported by an independent educational grant from Janssen, the Pharmaceutical Companies of Johnson & Johnson.

uroluts.uroweb.org Each course will be individually accredited by EACCME

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uroweb.org/education March/May 2020

European Urology Today

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Report

ESU-ESOU masterclass: "Inspiring, engaging and familial" Essentials on NMIBC strategies, technologies, and techniques By Erika De Groot Through the collaborative efforts of the European School of Urology (ESU) and the EAU Section of Oncological Urology (ESOU), the third edition of the ESU-ESOU Masterclass on Non-MuscleInvasive Bladder Cancer commenced in Prague, Czech Republic from 20 to 21 February 2020. The masterclass delivered essentials and vital updates on NMIBC management; from diagnostic and therapeutic strategies, emerging technologies, modern techniques to patient stratification.

in my clinical practice. Also the discussions on interesting cases will facilitate the way of resolving some similar clinical cases that occur at my institution.” According to Drs. De Vries, Pascual Fernandez, and Saed stated that their expectations, too, were met. Dr. De Vries said, “The masterclass was very inspiring. I enjoyed almost everything, from the live surgeries, presentations, difficult cases to the caveats in the knowledge on NMIBC.” “There was also a sense of familial feeling during the masterclass,” added Dr. Pascual Fernandez.

In this article, four enthusiastic delegates Drs. Remco De Vries, Angela Pascual Fernandez, Mohamed Saed and Ivo Vujicic share their reasons for joining the masterclass, what they hope to bring to their clinical practice, and their personal highlights. Two of the renowned faculty members Dr. Antonín Brisuda and Prof. Dr. Fredrik Liedberg spoke about their overall impressions of the masterclass.

Masterclass experiences “My colleague who previously attended this masterclass suggested that I participate this year. So I applied to exchange knowledge with other urologists, and learn more about NMIBC diagnosis and treatment. I was especially interested in the modern techniques of en bloc resection of a bladder wall tumour. I hope to use the information I received on the management of patients with BCG (Bacillus Meeting expectations Calmette-Guerin) failure and management of TURBT When asked if the masterclass met his expectations, (transurethral resection of bladder tumour) Dr. Vujicic said that he learned a great deal about the complications in my clinical practice, as well as, current perspectives on tumour classification and the facilitate the implementation of the procedures main indications of radical cystectomy. “These will improve the treatment of patients with bladder tumours demonstrated during the live surgeries,” shared Dr. Vujicic.

To Dr. Pascual Fernandez , the goal was to receive vital updates and techniques to benefit her daily clinical practice. “My favourite parts of the masterclass was learning about the tips and tricks on en bloc resection and obturator nerve block.” Rewarding and memorable moments “What I appreciated in particular was the overall significant interest in the course. I didn’t observe any negative feedback from the delegates’ side. In the post-course assessment, there were only four- or five-point marks, five being the highest rating one could possible give,” shared Dr. Brisuda. He added, “The broad interactivity with and among the delegates was also noteworthy. There were numerous discussions, a lot of questions were asked, and notes were taken right away. The deliberations did not strictly stick to the topic at hand, which gave the masterclass an easy-going, warm and friendly atmosphere overall. Also during the moments of waiting for the streaming of the live surgeries were filled with interactive discussions on different topics and problems, which actually kept the masterclass from adhering to the schedule.” To Prof. Liedberg, interaction with fellow faculty members and the delegates during the masterclass

Dr. De Vries stated, “I joined the masterclass to check if my NMIBC knowledge was still up-to-date. I wanted to learn about the latest developments on NMIBC diagnosis and treatment from the experts. Also, it is important to know more about the correct staging and the new techniques involved with that.”

Masterclass offers essentials in NMIBC management

was always a rewarding, knowledge-sharing opportunity. “The masterclass-setting with its semi-live/live-surgeries, the interactive casediscussions, and the insightful lectures stimulated engagement and brainstorming.” Pursuing other ESU masterclasses Dr. De Vries shared that he might attend the ESU-ESUT Masterclass on Operative Management of Benign Prostatic Obstruction and ESU-ESUT Masterclass on Urolithiasis. Dr. Saed expressed he also hopes to join the BPO masterclass. Due to his interests in stone surgery, Dr. Vujicic said he aims to participate in the urolithiasis masterclass as well. Dr. Pascual Fernandez is contemplating on taking the ESU-ESUT-ESUI Masterclass on Focal Therapy for Localised Prostate Cancer.

Easy-going atmosphere at the masterclass

The masterclass for you Find out which ESU masterclass is for you. Visit www.esu-masterclasses.uroweb.org for more information.

ESU-ESOU Masterclass on Non-Muscle-Invasive Bladder Cancer

ESU-ESOU Masterclass on Muscle-Invasive Bladder Cancer

4-5 February 2021, Prague, Czech Republic

8-9 April 2021, Amsterdam, The Netherlands

www.esunmibc21.org

www.esumibc.org

An application has been made to the EACCME® for CME accreditation of this event

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Dr. Saed applied for the masterclass to update his knowledge in bladder-cancer management as well. He said, “The masterclass made an impact on me and showed me possible treatments in the future.”

Faculty members (L – R) Profs. L. Lusuardi, M. Roupret, F. Witjes, J. Palou, M. Babjuk, A. Breda, B. Malavaud and F. Liedberg

European Urology Today

An application has been made to the EACCME® for CME accreditation of this event

March/May 2020


Report

ESU course delivers crucial PCa & BCa updates in Rabat Impressions, faculty feedback, and course recap

ESU Event Calendar Date

Event name

Location

JUNE 2020 19-20

By Erika De Groot Over a hundred participants convened in Rabat, Morocco in February of this year for the course “Update on prostate and bladder cancer” which was organised by the European School of Urology (ESU) in conjunction with the national congress of the Moroccan Association of Urology. The ESU course was presided by internationallyknown experts Course Chair Prof. Lütfi Tunç (TR), Prof. Mohamed Amine Lakmichi (MA), and local organisers Prof. Mohammed Alami (MA), Prof. Mohammed Ghadouane (MA). The course commenced with an introduction about the ESU: its history, diverse activities and the many opportunities it offers. This was followed by a comprehensive presentation of Prof. Tunç on the current EAU Guidelines recommendations for urolithiasis which covered diagnostic imaging; laboratory analysis; disease management for renal colic, sepsis and anuria; active removal of ureteral stone; antibiotic therapy; and urinary stones during pregnancy, to name a few. Thereafter, the participants received expert insights on the techniques and tricks of for optimal implementation of percutaneous nephrolithotripsy and ureteroscopic lithotripsy. Prof. Tunç also shared his knowledge and experience on the role of advanced laparoscopy in the era of robotics. According to Prof. Tunç, residency training programmes can set the trend wherein laparoscopy can remain an integral part of surgical education. He noted that the cost of robot technology is too expensive compared to the cost of laparoscopy technology. In addition, Prof. Tunç stated that although robotic surgery “cannot be performed everywhere, laparoscopy is a feasible surgery everywhere.”

“”..the participants received expert insights on the techniques and tricks of for optimal implementation of percutaneous nephrolithotripsy and ureteroscopic lithotripsy…” As the concluding part of the course programme, case discussions took place under the guidance of Prof. Lakmichi, to encourage knowledge-sharing and to review newly-acquired information. Prof. Tunç and Prof. Lakmichi also shared their impressions of the course and its participants, as well as, recommendations. What was your overall impression of the ESU course? Prof. Tunç: First of all, I would like to state that I am truly proud to have been part of this ESU course.

ESU-ESUT Masterclass on Urolithiasis

Virtual Masterclass

SEPTEMBER 2020

Prof. M.A. Lakmichi

Prof. L. Tunç, Course Chair

The room was packed. It was very crowded. I could tell the participants were interested in the information we were presenting. In my opinion, the content of the course programme and the delivery suited the audience. Prof. Lakmichi: I agree, the programme content was appropriate. It was a successful ESU course on every level, no doubt. The interaction with the participants, their questions and the interest they’ve shown proved that. Also the delivery of the presentations were clear and concise. You both mentioned that the content of the programme suited the audience. Why do you think so? Prof. Tunç: In every presentation, there were lively discussions; the participants were eager to interact. I observed that they were knowledgeable and competent in stone surgeries, particularly percutaneous nephrolithotomy and retrograde intrarenal surgery. Prof. Lakmichi: In Morocco, we're at a turning point with semi-invasive surgeries in urology such as endourology and laparoscopy. Urologists are increasingly drawn to these approaches. Everyone in the audience liked the review of the EAU Guideline and the following presentations. Through the course, we gave our real-world experience in endourology and laparoscopy through tips and tricks during my case discussions. With regard to the courses in the future, the ESU office and/or local organisers, what are your recommendations? Prof. Tunç: It was evident that they were very interested in the topics presented, as well as, with laparoscopic surgeries. I think it would be beneficial to organise more laparoscopy courses in Morocco. Prof. Lakmichi: No recommendations, really. The ESU and the local organisers did excellently. I look forward to further collaborations such as this ESU course. One of my aspirations is to be part of it as an academic urologist, simply because I love teaching and I think it’s rewarding to be able to contribute to the field and to fellow urologists from different parts of the world. For more information about the ESU and its activities such as courses, masterclasses, and online activities, please visit www.uroweb.org/education and www.esu-masterclasses.org.

4-9 11-12 13 15-16 25 25

18th European Urology Residents Education Programme (EUREP) EAU Update on Prostate cancer (PCa20) ESU course during the national congress of the Russian Society of Urology 7th ESU – ASU joint teaching course during the 43rd Annual Scientific Meeting of Indonesian Urological Association (ASMIUA) ESU course on New technologies in urology during the national congress of the German Association of Urology ESU course during the national congress of the Armenian Association of Urology

Prague (CZ) Madrid (ES) Kazan (RU)

Makassar (ID) Leipzig (DE) Yerevan (AM)

OCTOBER 2020 1-2 2 3 15 22 22 28 29-30

ESU-ESAU-ESGURS Masterclass on Erectile restoration and Peyronie's disease ESU course on Upper tract laparoscopic surgery during the national congress of the Albanian Association of Urologic Surgeons ESU course during the national congress of the Hellenic Urological Association ESU course on Technological innovations in the diagnosis and minimally invasive treatment of prostate cancer – Where are we in 2020? during the national congress of the Czech Urological Society 7th Confederación Americana de Urologia Residents Education Programme (CAUREP) ESU course on Dealing with the challenge of infections in urology during the national congress of the Tunisian Urological Society ESU course on Urinary incontinence in children and adults during the national congress of the Polish Urological Association ESU-ESFFU Masterclass on Functional urology in clinical practice during the European Lower Urinary Tract Symptoms meeting (ELUTS20)

Leuven (BE)

Tirana (AL) Thessaloniki (GR)

Olomouc (CZ) Guayaquil (EC)

Hammamet (TN)

Poznan (PL)

Barcelona (ES)

NOVEMBER 2020 5-7 12-15 14 20 19-20 25 26-27

ESU-ERUS courses during the 17th Meeting of the EAU Robotic Urology Section (ERUS) ESU courses during the 12th European Multidisciplinary Meeting in Urological Cancers (EMUC) ESU course on Diagnostic and therapeutic management of male infertility during the national congress of the Cyprus Urological Association ESU course on Update in bladder and prostate cancer during the national congress of the Turkish Association of Urology ESU-ESUT Masterclass on Lasers in urology ESU course on Tips and tricks in challenging surgeries during the national congress of the Spanish Urological Association ESU-ESUI Masterclass on Prostate biopsy

Düsseldorf (DE) Athens (GR)

Limassol (CY)

Antalya (TR) Barcelona (ES)

Burgos (ES) Marseille (FR)

DECEMBER 2020 2-4

ART in Flexible - Step 2, Berlin (DE)

FEBRUARY 2021 4-5 12-14

ESU-ESOU Masterclass on Non-muscle-invasive bladder cancer ESU course during the 18th meeting of the EAU Section of Oncological Urology (ESOU)

Prague (CZ) Gotenburg (SE)

APRIL 2021 8-9 15-17 6-8 28-29

ESU-ESOU Masterclass on Muscle-invasive bladder cancer URO Berlin Skills Teaching and Training (UROBESTT) ESU ESTs2 workshop – Endoscopic stone treatment step 2 ESU course on Percutaneous nephrolithotripsy (PCNL) during the 7th Baltic Meeting in conjunction with the EAU

Amsterdam (NL) Berlin (DE) Prague (CZ) Minsk (BY)

JULY 2021 12-16

March/May 2020

ESU – Weill Cornell Masterclass in General urology

Salzburg (AT)

European Urology Today

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Young Urologists/Residents Corner A chance of 1 out of 50,000 A rare case of devastating Fournier’s Gangrene after circumcision Dr. Fabian Aschwanden Dept. of Urology Luzerner Kantonsspital Lucerne (CH) fabian.aschwanden@ luks.ch

Prof. Agostino Mattei Dept. of Urology Luzerner Kantonsspital Lucerne (CH)

agostino.mattei@ luks.ch

After a 66-year-old man had been diagnosed with devastating Fournier’s Gangrene (FG) after circumcision, he was treated with antibiotics and surgical debridement. He spent six days in the intensive care unit. Subsequently, plastic surgery was performed. After 38 days of hospitalisation, he was successfully discharged. We discuss risk factors, presentation and management of FG. What is Fournier’s Gangrene? FG is an aggressive and potentially life-threatening necrotising bacterial infection, affecting the fascial planes and soft tissues of the perineum and the external genitals. The disease, first reported by Fournier in 1883, is mainly associated with men over the age of 50, suffering from immunodeficiency, particularly diabetes. Further risk factors are malnutrition, malignancy and alcohol overindulgence1. Clinical presentation typically includes painful swelling of the perineum and scrotum combined with systemic signs of sepsis. Due to the rapidity of the infection’s progression along the fascial planes and the related mortality, prompt diagnosis and treatment is crucial.

"Diabetes is a well-known risk factor for FG." Case presentation The 66-year-old patient was in a good general health prior to the incident, despite having suffered from a cough for the last days. His past medical history included diabetes, arterial hypertension, dyslipidaemia, and benign prostate enlargement. Accordingly, his regular medication consisted of a SGLT-2 inhibitor, metformin, aspirin, an HMG-CoA reductase inhibitor, and tamsulosin. Due to recurrent balanoposthitis with secondary cicatrisation, routine circumcision and meatus plastic was performed in an outpatient setting. Two days after the procedure, he appeared in the emergency department. He complained about a painful swelling of the penis and the scrotum, anuria for more than 12 hours and distinct malaise. However, fever and shivering were denied. He was in a poor general condition showing severe hypotension (55/45 mmHg), tachycardia (110 bpm), tachypnoea (30/min), but no fever (36.6°C). The Sequential Organ Failure Assessment (SOFA) score was 7 points (maximum of

24), predicting a mortality of 21.5%2. A livid, oedematous swelling of the scrotum and the penis shaft with beginning partial skin blistering and necrosis as well as an erythema spreading to the suprapubic region were observed. However, skin crackling during examination was not present. Blood results showed leucocytosis (12.3 G/L), a CRP of 210 mg/L, lactate acidosis (lactate 7.8 mmol/L), acute kidney failure (eGFR 21ml/min/1.73m2), while HbA1c was 7.3%. On the CT-scan, diffuse soft tissue swelling of the penis and the scrotum without gas cavities were evident (see figure 1). After immediate intravenous fluid resuscitation and commencement of intravenous piperacillin, tazobactam and clindamycin, the patient was taken to the operating room for debridement. A widespread excision and debridement, including the whole scrotum, was performed (see figure 2). The testes, the glans penis and the deeper structures were not affected by the infection and could be spared. Negative pressure wound therapy (NPWT) and a faecal management system (Dignishield®) for wound protection were installed. After the operation, the patient was admitted to the intensive care unit for a total of six days; he was intubated for four days. Ultimately, he underwent five further debridements. The antibiotics were rationalised according to the microbiology, being positive for streptococcus pyogenes.

"Therapy with SGLT-2 inhibitors and infection of the upper respiratory tract are suspected to increase the risk of FG." By day 20 of his admission, a vertical posteromedial thigh flap and split skin graft were performed by the plastic surgery team (see figure 3). Additional surgical revision had to be performed due to a postoperative bleeding after plastic surgery. Finally, the patient was discharged after a hospitalisation of 38 days and a total of 8 surgeries. Subsequently, he spent another 47 days in rehabilitation before going home. The wound conditions three months after the operation are shown in figure 4. Discussion Circumcision is a rare cause for FG. Galukande et al. report two cases out of 100,000 circumcisions, which suggests an incidence of 2/100,0003. According to a recent study, SGLT-2 inhibitors are considered to be associated with an elevated risk of FG4. Our patient was suffering from diabetes and was under SGLT-2 inhibitor treatment; however, this treatment was paused approximately 10 days before surgery. It remains unknown if it was paused because of the suspected elevated risk of FG or for other reasons. Commonly, FG is a polymicrobial infection; in this case only S. pyogenes was identified. S. pyogenes is a typical pathogen that causes infections of the upper respiratory tract. It is hypothesised that in case of an infection of the upper respiratory tract, S. pyogenes probably enters the blood stream and binds from there to vimentin which is excessively expressed in injured muscle cells5, leading to necrotising fasciitis. As our patient was suffering from a cough, an infection of the upper respiratory tract seems indeed possible but cannot be proven retrospectively.

Figure 3: Status before, while, and directly after plastic surgery

Conclusion FG is a devastating necrotising infection, requiring immediate surgical treatment. Diabetes is a wellknown risk factor for FG. Furthermore, therapy with SGLT-2 inhibitors and infection of the upper respiratory tract are suspected to increase the risk. However, further investigations are necessary to evaluate the association between upper respiratory tract infections, as well as therapy with SGLT-2 inhibitors, and the risk of FG.

4. Bersoff-Matcha SJ, Chamberlain C, Cao C, Kortepeter C, Chong WH. Fournier gangrene associated with sodium-glucose cotransporter-2 inhibitors: A review of spontaneous postmarketing cases. Ann Intern Med. 2019;170(11):764-769. doi:10.7326/M19-0085 5. Bryant AE, Bayer CR, Huntington JD, Stevens DL. Group A Streptococcal Myonecrosis: Increased Vimentin Expression after Skeletal-Muscle Injury Mediates the Binding of Streptococcus pyogenes . J Infect Dis. 2006;193(12):1685-1692. doi:10.1086/504261

References

Figure 1: CT scan showing diffuse soft tissue swelling of the scrotum

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European Urology Today

Figure 2: Wound conditions after debridement

1. Chennamsetty A, Khourdaji I, Burks F, Killinger KA. Contemporary diagnosis and management of Fournier’s gangrene. Ther Adv Urol. 2015;7(4):203-215. doi:10.1177/1756287215584740 2. Vincent JL, Moreno R, Takala J, et al. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996;22(7):707-710. http://www.ncbi.nlm.nih. gov/pubmed/8844239. Accessed January 25, 2020. 3. Galukande M, Sekavuga DB, Muganzi A, Coutinho A. Fournier’s gangrene after adult male circumcision. Int J Emerg Med. 2014;7(1):4-7. doi:10.1186/s12245-014-0037-0

Figure 4: Wound conditions three months after the operation

March/May 2020


Young Urologists/Residents Corner Iberic Resident Play: Webinars enlighten challenging topics New edition on metastatic renal cancer provides useful tools for residents Dr. Marta Antón Juanilla Dept. of Urology Hospital Universitario Cruces Barakaldo (ES)

Cytoreductive nephrectomy The new role of cytoreductive nephrectomy was also highlighted. Both the Carmena2 and Surtime3 trial redefined its application to symptomatic patients with a favourable response after target therapy and with a low metastatic charge alongside a good physical status.

marta.antonjuanilla@ osakidetza.eus

In regard to metastasectomy, the last review published by the Young Academic Urologists Kidney Cancer Working Group of the EAU in 20194 provided us with the key; the most important prognostic factor in survival is the complete resection of the metastasis.

A new edition of the Iberic Resident Play took place in Bilbao (ES) on 23 January 2020. This was a good opportunity to start 2020 deepening our knowledge about metastatic renal cancer, a relevant subject which has undergone important changes in clinical management these last few years. All urologists involved in patient care, even those who are not involved in onco-urology, appreciate having an up-to-date knowledge of this field. A total of 155 urologists and residents followed the conference through streaming from sixteen locations spread all over the country. Dr. Jorge Gonzalez Tampan (ES), attending urologist from the Basurto University Hospital (ES), acted as one of the guest speakers guiding the audience through the last clinical evidence published about risk scoring systems, cytoreductive nephrectomy and metastasectomy.

Dr. Marta Antón Juanilla (ES), fourth year urology resident, animated the meeting by presenting several clinical cases and launching questions to the public, who could answer them with an interactive app. Debate was guaranteed when the results did not show a unanimous response. This kept the audience hooked for an hour.

Enlightening challenging subjects Since 2015, GlaxoSmithKline (GSK) has already sponsored eleven editions of the Iberic Resident Play. These webinars, led by experts and focussed on residents, have proven themselves to be a useful tool in urological education. The surgical treatment of benign prostatic hyperplasia was the first subject Transmitting expertise to new generations Dr. Roberto Llarena Ibarguren (ES), clinical chief of to be discussed through this platform. Since then, urology at the Cruces University Hospital (ES), did not other topics such as retroperitoneal miss his opportunity to transmit his broad expertise in lymphadenectomy in testicular cancer, management the management of metastatic renal cancer patients of urological trauma and management of urothelial carcinoma have come after. The Iberic Resident Play to new generations. He did a great review about the different drugs available in the market, how to deal is expected to keep on enlightening challenging with the side effects and when it is the right time to subjects in the future. switch. He emphasised the new role that immunotherapy is already playing in this urological field.

He also mentioned the EAU guidelines as a good roadmap to Besides explaining how the Memorial Sloan-Kettering understand the available Cancer Center (US) and the Metastatic Renal Cancer treatments and of which Database Consortium create their risk classifications, a line these treatments novel risk scoring system published in The Oncologist 1 are part. New updates were offered without was discussed. This novelty incorporates the body mass index, the monocyte-to-lymphocyte ratio and the forgetting the limitations urologists can sometimes sites of metastatic disease to predict overall survival find in health care and progression-free survival in patients treated with systems. immune checkpoint inhibitors.

Webinars are available through gskpro.com/es-es/areas-terapeuticas/urologia/ sesiones-formativas-online/resident-play-pasados/ References 1. Martini DJ, Liu Y, Shabto JM, et al. Novel Risk Scoring System for Patients with Metastatic Renal Cell Carcinoma Treated with Immune Checkpoint Inhibitors. Oncologist. 2019 Dec 5. doi: 10.1634/theoncologist.2019-0578. [Epub ahead of print] 2. Méjean A, Ravaud A, Thezenas S, Colas S, Beauval JB, Bensalah K, et al. Sunitinib alone or after nephrectomy in metastatic renal-cell carcinoma. N Engl J Med. 2018;379(5):417–27. 3. Bex A, Mulders P, Jewett M, Wagstaff J, van Thienen JV, Blank CU, et al. Comparison of immediate vs deferred cytoreductive nephrectomy in patients with synchronous metastatic renal cell carcinoma receiving sunitinib: The SURTIME Randomised Clinical Trial. JAMA Oncol. 2019. February 1;5(2):164–70 4. Ouzaid I, Capitanio U, Staehler M, et al. Surgical Metastasectomy in Renal Cell Carcinoma: A Systematic Review. Eur Urol Oncol. 2019 Mar;2(2): 141-149

Dr. Marta Antón Juanilla presented several clinical cases and asked questions to the public, who could answer them with an interactive app.

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European Urology Today

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ESOU redesigns strategies, launches ESOU Online New initiatives and digitalisation of resources Last January, the 17th meeting of the EAU Section of Oncological Urology (ESOU20) took place in the wonderful city of Dublin in Ireland. As ESOU Chairman, it was the first meeting I had the opportunity to organise together with the board.

Association of French Urology (CCAFU), Spanish Urology Association for Oncological Treatment (CUETO), French Genito-Urinary Group (GETUG) and Scandinavian Prostate Cancer Group (SPCG) were highlighted.

The yearly stand-alone ESOU meeting has a unique objective: To provide an overview of the newest developments and data in the field of onco-urology delivered by leading experts in prostate, kidney and bladder cancers, and rare neoplasms. From this perspective, the meeting was a huge success. It was very eclectic and representative of all genito-urinary cancers as reflected in the exhaustive report from Dr. Catherine Dowling.

• Young colleagues were encouraged to write scientific articles based on the content presented at the meeting. The best article will be published in the European Urology Oncology journal.

I would like to thank all the faculty for delivering such an exquisite overview of the best of oncourology of 2019, and to our local host, Prof. Thomas Lynch, who was very keen to help organise the meeting.

• Two videos for "ESOU Online" were recorded for the EAU Edu Platform, UROONCO (www.uroonco. uroweb.org).

The ESOU meeting was a good opportunity to launch the following new initiatives from the section: • Clinical trials and national groups of research such as the Committee of Cancerology of

• American Society of Clinical Oncology (ASCO) presented the state-of-art lecture "Perioperative risk stratification and complications of radical cystectomy".

• We planned to refresh the format of the STEPS Programme and designate four winners as speakers at the 18th edition of the meeting. Nevertheless, I am now writing these words in the light of the COVID-19 pandemic situation. As safeguarding the population is top priority, investing in virtual tools and digital events becomes the fitting alternative. It is fascinating to see how scientific societies have adapted to the concept of full virtual meeting (e.g. ASCO’s event in May and EAU’s Annual Congress in July).

technologies to minimise our carbon footprint. Perhaps a "green section" in the European Urology Today where eco-friendly ideas are collated together as another way for urologists to connect with one another and to the planet.

Letter from the ESOU Chairman

Lastly, we do not want to add an oncology crisis to the pandemic situation, which is disrupting global healthcare worldwide. Surgery prioritisation remains dependent on regional COVID-19 incidence, manpower and supplies. Several urology departments and associations made their own priority plan to categorise oncological emergencies such as the newly set up Guidelines Office Rapid Reaction Group (GORRG). However, it is obvious that the quality of care in these cancer patients is decreased in the time of the COVID-19 pandemic. Even patients were afraid to overcome the lockdown to seek a medical opinion during this difficult and troubled period. For patients diagnosed with (or suspected to have) cancer, the current situation is truly challenging: Anxiety that the treatment for their cancer will be neglected; fear of contracting the severe form of COVID-19; and worry about the repercussions of the pandemic. Thus, it is of utmost importance that we keep sharing the latest novelties, scientific data, and insights about onco-urology. The ESOU section will invest a lot of time and energy to explore all possibilities to guarantee scientific exchanges for a brighter future for our patients.

Prof. Morgan Rouprêt University Hospital Pitié-Salpétrière, Dept. of Urology, Sorbonne University, Paris (FR)

From that perspective, ESOU launched the previouslymentioned “ESOU Online” initiative where you will find the latest data abridged by experts in the field; from state-of-the art lectures, debates, clinical cases, drugs in the pipeline, to guidelines. All you need to know about onco-urology will be available online in the months to come via the URO ONCO platform of the European School of Urology.

ESOU to pursue virtual alternatives

The present situation is also an opportunity to rethink how we manage resources and use better

ESOU20 was a huge success

A response to limited scientific progress in urolithiasis EULIS has launched a new working group: eCORE - EULIS Collaborative Research Prof. Kemal Sarica Chairman, EAU Section of Urolithiasis (EULIS) Istanbul (TR)

treatment of renal stones (PNL) and the ureteroscopic removal of stones (URS), were introduced. These modalities have gradually replaced open surgery over the last 35 years. Success rates in terms of stone-free status have increased and complication rates associated with an open surgery decreased to a certain extent.

As a working group consisting of multidisciplinary members, eCORE mainly aims to conduct research activities by having timely meetings and publications. With this aim, eCORE will create bridges between related disciplines in an attempt to bring new insights into pathophysiology, metabolic evaluation, and medical as well as minimally invasive surgical management of urolithiasis. eCORE will perform all these activities in a standardised manner with stepwise flow charts; adequate infrastructure will be prepared, research activities will be initiated, progress will be followed, research activity will be finalised, and the obtained data will be published. eCORE will conduct regular timed meetings in an attempt to follow all these scientific activities as well as to ensure and supervise the continuity of the accepted research projects.

Superficial outcomes However, as stated above, despite evident achievements in the clinical treatment of urolithiasis, our knowledge of the pathophysiologic mechanisms of stone formation, including some fundamental Prof. Selcuk Guven issues, is still limited. The number of publications is Coordinator, EULIS limited, and little progress has been made in the Collaborative basic research field of this disease due to decreasing Research (eCORE) enthusiasm among the new generation. One factor Working Group that has made basic research into urolithiasis less Istanbul (TR) "eCORE mainly aims to conduct appealing to urologists is the efficient and successful removal of urinary calculi with the contemporary research activities by having timely minimally invasive treatment modalities as this selcukguven@ meetings and publications." doesn’t significantly change a patient's quality of life. hotmail.com As a result, a deep insight into the basic research field of urolithiasis inevitably shows superficial, dispersed With these intentions, eCORE was founded on 31 The incidence of urolithiasis is steadily increasing in outcomes; outcomes which have limited contributions October 2019. It consists of twelve members. There is some specific if not all parts of the world, both in also an advisory board with three members: a to the scientific progress of the literature. adults and children. Although the exact mechanism of nephrologist, basic scientist, and an epidemiologist. stone disease is still to be fully outlined, tremendous In the light of the facts stated above, a need has advancements both in the instrumentation as well as in emerged to organise our daily clinical practice, basic First observational clinical studies the minimally invasive management techniques of research work, and organisational administration in a The first scientific activities of this newly formed EULIS urinary calculi have been introduced to clinical working group have been set in motion with two balanced as well as standardised manner. applications in the last 25 years. Parallel to these observational clinical studies. The ethics committee achievements, the number of publications focussing on Advancement of knowledge approved the protocol of the first prospective the basic research and clinical aspects (particularly The EULIS Collaborative Research Working Group observational study, after which the informed consent emphasising the importance of new technology) of (eCORE) project was put on the agenda of the EAU and Institutional Review Board (IRB) forms were urolithiasis seems to have increased during this period. Section of Urolithiasis (EULIS) board in response to our prepared and registered in the Clinicaltrials.gov disappointment at failing to plan and conduct better, website on behalf of EULIS (see www.clinicaltrials. Related to this issue, following the first adult case promising, and contributing projects in particularly the gov/ct2/show/NCT04169165). This study is a patient treated with extracorporeal shock wave lithotripsy basic research field. The primary mission given to compliance study (COMET study: COmpliance to (ESWL) in the early 1980s, new minimally invasive eCORE is to achieve the EULIS objectives, to facilitate METabolic evaluation and treatment), its protocol treatment modalities, namely the percutaneous the advancement of knowledge, investigation and number is EULIS eCORE-S-19-001, and the leading modern treatment of urolithiasis, and to promote author is Dr. Ilker Gokce (TR). With the support of the dialogue, research as well as education about all EAU Research Foundation (EAU-RF), an electronic case EAU Section of Urolithiasis (EULIS) aspects of urinary stone disease. report form (CRF) has been prepared and an electronic saricakemal@ gmail.com

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date capture (EDC) system has been created by Castor. The study is planned to be initiated in May 2020. The second approved prospective observational project is entitled "Active surveillance for renal stone fragments following ureteroscopy and Ho: YAG laser lithotripsy: a prospective observational multicentric study.” The leading author of this study is Dr. Luca Villa (IT). He is in the process of applying to the ethics committee of the Università Vita-Salute San Raffaele (IT). In addition to observational studies, eCORE aims to outline the most critical parameters of patient evaluation during the medical as well as surgical management of stones by focussing on properly designed questionnaires and using the correctly assigned target groups. For this purpose, two software questionnaires have been prepared; one of which focusses on the current practice patterns, while the other one focusses on the training standard in the minimally invasive stone treatment field. These two questionnaires, named “Current Practice Patterns for Medium-Sized Renal Stones: EULIS Collaborative Research Working Group (eCORE) Global Survey” (protocol number EULIS eCORE-Q-20-001) and “eCORE-EFT Study: How should the training of flexible ureterorenoscopy be for the residents?” (protocol number EULIS eCORE-Q-20-002), are ready to be circulated among the target group. COVID-19 While these preparations were being done, we faced an extraordinary series of events locally and globally due to the COVID-19 pandemic. We, as the EULIS eCORE working group, decided to produce an up-to-date article on how the practice patterns for endourologists need to be changed in the management of stone disease and to provide a treatment algorithm during this pandemic. The manuscript entitled “Urolithiasis Practice Patterns Following COVID-19 (Novel Coronavirus Disease 2019) Pandemic: eCORE (EULIS Collaborative Research Working Group) Overview” is under consideration for publication elsewhere. March/May 2020


ESOU20 unveils contemporary GU updates Top treatments, IO, and trial developments Dr. Catherine Dowling Galway University Hospital Galway (IE)

catherine.dowling@ hse.ie The 17th meeting of the EAU section of Oncological Urology (ESOU20) took place from 17 to 19 January 2020 in the beautiful medieval city of Dublin, Ireland. This cutting-edge meeting, chaired by Prof. Morgan Rouprêt (FR), certainly delivered on its promise in providing a mix of round-table discussions, scientific lectures, and rapid-fire presentations with an interactive approach. Approximately 1,000 delegates attended the meeting. Expanding the indication for active surveillance Dr. Romain Mathieu (FR) presented a clinical case of Gleason 3+4 prostate cancer and posed the question if any subset of Gleason 3+4 should be included in active surveillance cohorts. He cited the recently published cohort of Dr. Laurence Klotz (CA) and concluded that a small subset of patients may be suitable where the Gleason 4 component is less than 5%. Predictive factors for the development of metastatic disease in patients with Gleason 3+4 prostate cancer were three or more cores involved and a PSA doubling time of less than three years.

Prof. Steven Joniau (BE) presents his lecture “Prostate cancer II: Pushing the boundaries”

during radical prostatectomy (RP). He reported similar oncological outcomes and better patient reported sexuality outcomes in patients in the NeuroSAFE group compared to patients from the non-NeuroSAFE group. In pre-RP potent men, erectile function was preserved in 74% of men in the NeuroSAFE Group and in 46% in those from the non-NeuroSAFE Group. Small renal masses The focus shifted to renal cell carcinoma (RCC) when a lively debate on the best treatment option of small renal masses in elderly patients took place. Dr. Maria Carmen Mir Maresma (ES) and Dr. Raul Martos Calvo (ES) advocated surgical management with radical and partial nephrectomy, respectively. However it was Prof. Alessandro Volpe’s convincing argument in favour of non-surgical management seemed the most popular. He advocated the use of the Fox Chase nomogram to predict overall survival and competing risks of death in patients with localised RCC. Prof. Karim Touijer (US) delivered a futuristic view on the use of augmented reality and its role in the operative management of renal cancer. He demonstrated the ability to overlay a 3D image of the kidney with the tumour and vasculature to enhance surgical approach and selective ischaemia. An experienced panel then discussed the management of challenging localised renal cancer cases.

A full house at an ESOU20 Plenary Session

ESOU 20 relapse in those with a rising miRNA during treatment. Furthermore, in a study of patients undergoing postchemotherapy retroperitoneal lymph node dissection (PC-RPLND), it was found that miRNA correlated with clinical parameters, tumour markers and histology, and ultimately may be able to determine if post-chemotherapy masses are viable germ cell tumour (GCT) versus necrosis or fibrosis. ESOU session on immunotherapy This year, an entire session focused on immunotherapy (IO) in urological cancers. Dr. Laurence Albiges (FR) and Dr. Susan Foller (DE) discussed the role of IO in metastatic RCC and presented the findings of Checkmate 214 where the overall survival for patients treated with Nivolumab and Ipilimumab was superior compared to Sunitinib. They also discussed how the findings of Keynote 426 trial integrated Axitinib plus Pembrolizumab into the guidelines as first-line treatment in metastatic RCC.

UTUC Prof. Shahrokh Shariat (AT) gave a compelling Local host Prof. Thomas Lynch (IE) emphasised the argument for preoperative chemotherapy in upper important role of a nephrologist in the pre-operative tract urothelial cancer (UTUC). He explained that workup of a patient with a solitary kidney. With radical nephroureterectomy alone is insufficient in dealing with complex renal masses, attendees were most patients given the risk of micrometastases. Prof. Best Scientific Paper Published in European Urology 2019 advised to give careful consideration to the clamping Shariat reported that preoperative chemotherapy (PC) presented by Dr Laurence Albiges (FR) to Dr. Pieter De Visschere, strategy and renorrhaphy technique. should be considered for high-risk tumour as a recent University of Ghent (BE) observational study of 267 patients treated with PC Availability of BCG reported a complete response of 10.1% and Prof. Jacques Irani (FR) presented the current situation downstaging in 44.9% (Shariat et all J Urol 2020). Dr. Mathieu stated that the heterogeneity of prostate of Bacillus Calmette-Guerin (BCG) availability cancer is not adequately captured with traditional throughout Europe. Strategies suggested to deal with Immunotherapy for NMIBC histopathological staging and thus clinical, genomic pending shortages were the use of alternate strains of Prof. Shariat explained the rationale for IO in and radiological biomarkers are the key to BCG, the use of intravesical Epirubicin or Gemcitabine non-muscle-invasive bladder cancer (NMIBC) as appropriate risk stratification and patient selection. for intermediate-risk disease and terminating programed death-ligand 1 (PD-L1) levels are highest maintenance after one year of treatment. In high-risk in carcinoma-in-situ and in patients with NMIBC not It was a full house during the discussions on disease, radical cystectomy remains the treatment of responsive to BCG. He cited findings from Keynote improving surgical approaches and managing choice. 057, a phase 2 study of patients with high-risk NMIBC complications in prostate cancer. Prof. Dr. Francesco unresponsive to BCG who are given Pembrolizumab Montorsi (IT) delivered a very elegant video with tips The role of micro RNA-371A-3P every three weeks, which reported a complete on preserving continence with manoeuvres including Prof. Dr. Axel Heidenreich (DE) gave a comprehensive response (CR) rate of 41.2%. He reported that bladder neck preservation, early ligation of the dorsal overview on the future use of micro RNAs (miRNA) for Pembrolizimub is easier to administer and safer than venous complex (DVC) and nerve-sparing technique. the follow up of testicular cancer. He explained the radical cystectomy. Prof. Shariat added that high sensitivity and specificity of miRNA, which can Pembrolizimub has acceptable efficacy where all Prof. Markus Graefen (DE) demonstrated the NeuroSAFE be used to monitor systemic therapy in testicular treatment failures remained NMIBC with no technique for intra-op frozen section examination cancer and may be utilised in determining early progression to invasive or metastatic disease.

Prize winners of the STEPS Programme

March/May 2020

17-19 January 2020 Dublin, Ireland

Revolution in first-line treatment for mRCC Sunday morning’s session on metastatic renal cell carcinoma (mRCC) demonstrated the impact of the CARMENA trial. When presented with a clinical case of mRCC and asked what they would do in 2015, the majority of the audience voted for a cytoreductive nephrectomy. Fast forward to 2020 and most voted for upfront immunotherapy after a very elegant talk on the basics of IO by Dr. Albiges. Prof. Arnaud Mejean (FR) and Dr. Gianluca Giannarini (IT) argued the pros and cons of cytoreductive nephrectomy while Mr. Arun Thomas (GB) from Dublin gave an excellent discussion on the role of retroperitoneal lymph node dissection (LND) in mRCC, and highlighted that most of the reported literature is retrospective data with no clear evidence for performing an LND. ASCO lecture During the state-of-the-art lecture of the American Society of Clinical Oncology (ASCO), Dr. Stephen Boorjian (US) delivered a fascinating talk on the unchanging morbidity and mortality rates in radical cystectomy over the last 10 years despite advances. He highlighted the importance of surgeon volume, as well as, hospital volume given the complex pre-, peri- and post-operative needs of patients undergoing radical cystectomy (RC). Citing the RAZOR trial (open versus robotic RC), Dr. Boorjian said that robotic surgery alone was not the answer. He advocated the use of Tranexamic acid to reduce perioperative transfusion rates and mentioned an ongoing trial (TACT trial in Canada) which will address this. He emphasised the importance of prehabilitation in this patient cohort as malnutrition should be viewed at a modifiable risk factor for complications after RC. About the ESOU meeting Annually held, the ESOU meeting is the quintessential platform that offers a wide-range, accurate overview of current novelties in onco-urology. The meeting also addresses other challenges such as the promotion of the role of European urologists as principal caregivers in genitourinary (GU) cancer treatment. For more information about the ESOU meeting, please visit www.esou.uroweb.org.

Some of the esteemed ESOU20 faculty members

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Examination with the whole-mount section technique A gallery of ten large-format, histological images of the prostate gland for clinicians Prof. Rodolfo Montironi Chairperson of the ESUP Polytechnic University of the Marche Region Ancona (IT) r.montironi@ univpm.it Co-authors: Dr. Alessia Cimadamore (IT), Prof. Marina Scarpelli (IT), Dr. Liang Cheng (US), Prof. Antonio Lopez-Beltran (PT) The following ten large-format, histology-based images show how the normal architecture of the prostate, including its components, appears to EAU Section of Uropathology (ESUP)

pathologists when the gland is processed with the whole-mount technique. We are sure that clinicians will see these images as a useful morphological basis when the prostate is examined intraoperatively or with imaging techniques. Image 1: Radical prostatectomy specimen following a bilateral nerve-sparing procedure. The margin is smooth and follows the surface of the prostate, i.e. the so-called “prostate capsule.” Image 2: Radical prostatectomy specimen following a bilateral nerve-sparing procedure. There is no true capsule; this is rather a condensation of prostatic stroma at the edge of the prostate (the rectangle indicates the whole-mount section as taken from the larger image). Image 3: Radical prostatectomy specimen following a bilateral non-nerve-sparing procedure. Periprostatic soft tissue with nerves (see arrow) and vessels (see asterisk).

Image 4: Radical prostatectomy specimen. Normal histology of the prostate according to John McNeal: the transition zone (see asterisk), i.e. the usual location of benign prostatic hyperplasia, the peripheral zone (see triangle) and the central zone with the ejaculatory ducts (see arrows). The latter two form the so-called “non-transition zone,” i.e. the most common location of prostate cancer. Image 5: Major prostatic duct emptying into the urethra at the level of the verumontanum. Image 6: The verumontanum. The utricle (see arrows) and the ejaculatory ducts (see asterisks) empty into the urethra at the level of the verumontanum. Image 7: The ejaculatory duct (see arrow) originating from the seminal vesicle (see asterisk). Image 8: Radical prostatectomy specimen following a non-nerve-sparing procedure. For the seminal

Image 1

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vesicles, see the arrows; for the spermatic duct, see the asterisk. Image 9: Radical prostatectomy specimen following a non-nerve-sparing procedure: lymph node in the periprostatic tissue (see arrow). Image 10: The base of the prostate. There is no boundary between the prostate (see asterisk) and the bladder neck (see arrow). For additional images, please see the following publication: Cimadamore A, Scarpelli M, Cheng L, Lopez-Beltran A, Galosi AB, Montorsi F, Montironi R. Re: Maria Chiara Sighinolfi, Bernardo Rocco's Words of Wisdom re: EAU Guidelines: Prostate Cancer 2019. Mottet N, van den Bergh RCN, Briers E, et al. https:// uroweb.org/guideline/prostate-Cancer/. Eur Urol 2019;76:871. Eur Urol. 2020 Feb 20. pii: S03022838(20)30102-0. doi: 10.1016/j.eururo.2020.02.005.

March/May 2020


Image 7

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Using a flexible ureteroscope for more than 500 procedures Possible or impossible? Prof. Petrisor Geavlete Dept. of Urology Saint John Emergency Clinical Hospital Bucharest (RO) geavlete@gmail.com Co-authors: Dr. Bogdan Geavlete (RO) and Dr. Razvan Multescu (RO) The development of the flexible ureteroscope into its modern form (including deflection capabilities, a working channel, and irrigation) began at the end of the eighties1. Since then, technological progress has brought about a spectacular development of this endoscope, which is nowadays one of the most important instruments in the diagnosis and treatment of upper urinary tract pathology.

as the Storz Flex-X, Storz Flex-XC, and Olympus URF-V2, usage between 100 and 200 procedures can probably be qualified as a very good durability in high volume centres3,4. Over time, various studies have been dedicated to the study of flexible ureteroscope damage. A paper of Sung et al. indicated that the major causes for flexible ureteroscope damage were perforations due to instruments passage, laser activation on the working channel, and extreme scope deflection. The authors also identified overtorquing during surgery and improper handling between procedures as main causes for a repair of an endoscope5.

"The development of guidelines for the intraoperative usage and handling of flexible ureteroscopes is the key to a longer lifespan."

Improving the durability (thus improving the efficacy and safety) was one of the main development goals during the last three decades. In 2000, the working time with a flexible ureteroscope before a major repair was between three and thirteen hours, or six and fifteen uses2.

Special techniques were proposed in order to increase the durability of these endoscopes, such as the â&#x20AC;&#x153;upside-downâ&#x20AC;? method of Lin CC et al. In this study, retrograde intrarenal surgery (RIRS) was performed on 546 patients using an Olympus URF-V ureteroscope; repairs were necessary on five occasions6.

That dramatically improved over the next twenty years, despite the fact that procedures became more complex and demanding. The last flexible ureteroscope employed in our department was an Olympus URF-V2, which was used for 158.6 hours (9517 minutes) or 526 procedures. Most of these procedures (91.8%) were therapeutic ones, to remove upper urinary tract lithiasis. After the last procedure, a major repair was necessary due to severe loss of the deflection capabilities (see figure 1) and a deformation of the distal part (see figure 2). Such a lifespan is unusually long, even for flexible ureteroscopes of the last generation. For models such

In our experience, the development of guidelines for the intraoperative usage and handling of flexible ureteroscopes, and strictly following these guidelines, is the key to a longer lifespan. The use of ureteral access sheath, gentle manipulation, lower pole stones relocation when possible, and minimisation of extreme deflection or torque are probably all important in using a flexible ureteroscope for a long period of time. Extreme care during manipulation and sterilisation between surgeries are equally important. Our aforementioned endoscope was used by only three urologists who all had great experience in the retrograde flexible

March/May 2020

Figure 1: The Olympus URF-V2 flexible ureteroscope has lost its deflection capabilities after 526 uses

Figure 2: Deformation of the distal part of the Olympus URF-V2 flexible ureteroscope after 526 uses

ureteroscopic approach of upper urinary tract pathology.

2. Afane JS, Olweny EO, Bercowsky E, Sundaram CP, Dunn MD, Shalhav AL, McDougall EM, Clayman RV. Flexible ureteroscopes: a single center evaluation of the durability and function of the new endoscopes smaller than 9Fr. J Urol. 2000 Oct;164(4):1164-8. 3. Defidio L, De Dominicis M, Di Gianfrancesco L, Fuchs G, Patel A. Improving flexible ureterorenoscope durability up to 100 procedures. J Endourol. 2012 Oct;26(10):132934. doi: 10.1089/end.2012.0178. Epub 2012 Jul 11. 4. Multescu R, Geavlete B, Georgescu D, Geavlete P. Improved durability of flex-Xc digital flexible ureteroscope: how long can you expect it to last? Urology. 2014 Jul;84(1):32-5. doi: 10.1016/j. urology.2014.01.021. Epub 2014 Apr 2. 5. Sung JC, Springhart WP, Marguet CG, L'Esperance JO, Tan YH, Albala DM, Preminger GM. Location and etiology of flexible and semirigid ureteroscope damage. Urology. 2005 Nov;66(5):958-63. 6. Lin CC, Wu LS, Huang SS, Lin CF, Chen WH, Wu CT. Surgical technique to achieve high durability of flexible ureteroscopes: A single hospital experience. Biomed J. 2018 Dec;41(6):385-390. doi: 10.1016/j.bj.2018.10.002. Epub 2019 Jan 11.

The highest potential of technological progress is far from being reached, so there is more room for improvement. If the future of flexible ureteroscopy will be reusable ureteroscopes, single-use ones, or both is a question to which only the future will offer an answer.

"Our endoscope was used by only three urologists who all had great experience in the retrograde flexible ureteroscopic approach of upper urinary tract pathology." References 1. Bagley DH, Huffman JL, Lyon ES. Flexible ureteropyeloscopy: diagnosis and treatment in the upper urinary tract. J Urol. 1987 Aug;138(2):280-5.

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“EU must do more on prostate cancer” A report of an EAPM session on early detection of prostate cancer By Sarah Collen, EAU Policy Coordinator “Prostate cancer is a silent killer of men across Europe, with men often almost having to apologise for asking for better care,” opened Prof. James N'Dow (GB), EAU Guidelines Office chair, as he moderated a session on early detection of prostate cancer in a virtual conference organised by the European Alliance of Personalised Medicine (EAPM). The event was due to take place in Brussels to mark the Croatian Presidency of the Council of the European Union, but had to move to a virtual format due to the public health challenges of COVID-19. First, Prof. Hein Van Poppel (BE) was asked to set the scene on the EU policy landscape and the current scientific opinion. The Innovative Partnership for Action Against Cancer (iPAAC), an EU Joint Action of the Ministries of Health funded by the EU Health Programme, has recently called for more clinical trials on prostate cancer screening, but Prof. Van Poppel said there is no need for more clinical trials as it is already clear from the results of large-scale trials that screenings are effective. Before the PSA blood test became available, up to a half of the prostate cancer patients died of the disease. Since PSA was introduced to detect prostate cancer at an early stage, the mortality from prostate cancer has decreased more dramatically than from any other cancer, at the cost however of overdiagnosis and overtreatment. These two issues have historically been the biggest factors against PSA testing. Algorithm The main advantage of PSA testing is that men at a higher risk of PCa are more likely to get an early diagnosis and may need less aggressive treatment. The treatment of late stages of the disease is extremely expensive and will only prolong life for two years on average, with a poor quality of life. Over the years, the EAU has produced gold-standard, multidisciplinary guidelines, which means that the issues of overtreatment and overdiagnosis need no

longer to be a barrier to a decent PCa early detection strategy being put in place. In fact, such a strategy can be seen in figure 1: the algorithm for early detection of prostate cancer, which has been developed as part of the EAU’s new White Paper on prostate cancer (see www.uroweb.org/policy/what-we-do/). The bottom line is that early detection of prostate cancer in well-informed men saves lives, improves quality of life and reduces costs for health care systems. There is hope for getting this overlooked condition on the EU agenda as the EU launched a consultation on a new EU cancer plan, with the possibility of adding early detection of prostate cancer to the initiatives that the European Commission can support.

"The EAU will continue to push the EU to achieve more in the fight against prostate cancer." Mission on Cancer Later into the session, Mr. Jan-Willem Van de Loo (BE) from the Directorate-General for Research and Innovation of the European Commission gave an update on the initiatives that will be taken up by the Commission. He highlighted the EU cancer plan and also the research “Mission on Cancer,” which is a new concept in Europe and will be funded through the EU’s future research and innovation programme (Horizon Europe). The Mission on Cancer will complement the activities of the cancer plan.

Prof. Anders Bjartell (SE) followed Mr. Van de Loo by presenting the Scandinavian experience with early detection. His evidence concurred with the evidence presented in Prof. Van Poppel’s introduction. Between 2009 and 2018, more men with low-risk cancer were managed with active surveillance in Sweden.

WHITE PAPER ON PROS TATE CAN CE R

Recommendatio ns for the EU Ca ncer Plan to tackle Prosta te Cancer

Prof. Bjartell also went on to explain the PIONEER big data project that is coordinated by the EAU for better outcomes of prostate cancer. This data can be used, for example to identify the best algorithm to reduce overdiagnosis as this has been done for the algorithm depicted in figure 1. Innovative screening practices Dr. Erik Briers (BE), who spoke on behalf of Europa Uomo, gave the patients perspective, particularly focussing on elements of risks to patients, which are predominantly elated to a lack of complete information on prostate cancer, which is why he is passionate about the EAU Patient Information work.

Prof. Maria Ribal (ES), vice-chair of the EAU Guidelines Office and head of the uro-oncology unit at the hospital clinic of the University of Barcelona (ES), gave a clear and precise final presentation on the innovative screening practices taking place in her clinic, where screening tools are used in a more Van de Loo is closely involved in the preparations for clever way, as a result of which quality of life has this mission, which is prepared under the guidance of a increased and the mortality of her patients has board. A discussion paper will be ready by April or May, reduced. when it will be shared and be up for discussion with all stakeholders, of which the EU citizens are key. Horizon More must be done Europe will have a strategy for continuous engagement Prof. N’Dow concluded the session saying that with EU citizens and missions are key parts in this more can and must be done for those impacted by engagement process. Due to COVID-19, most of the prostate cancer across Europe and that the EU interaction will be online in the coming months. cancer plan offers a unique opportunity for this

The EAU's new White Paper on prostate cancer is online; see www.uroweb.org/policy/what-we-do/.

gap to be addressed. It is too early to say exactly how prostate cancer will be addressed by either the mission or the EU cancer plan, but the EAU will continue to push the EU to achieve more in the fight against prostate cancer, for instance by informing and mobilising members to engage with debates which will have an impact on this disease. The full conference report of the EAPM conference can be found via www.euapm.eu/ pdf/EAPM_Conference_Report_-_Croatia_ Presidency_Defining_the_healthcare_ecosystem_ to_determine_value.pdf.

Prostate cancer: Risk-Stratified Early Detection Elevated PSA* 50-59: ≥3.0 (1000/10.000) 60-70: ≥3.0 (2500/10.000)

Reflex testing***

High and intermediate Risk (65%)

mpMRI** (100%)

PIRADS 1-2 (54%)

Low risk (35% MRI avoided)

* Once confirmed with 2-4 weeks interval. ** Eventually replaced by tri- or bi-parametric MRI. *** Family history, African-American origin, PSA density, BRCA2 gene mutation, nomograms/risk calculator (ERSPC and PCPT).

PIRADS 3 (6%)

PIRADS 4-5 (40%)

PSAD <0.15

PSAD >0.15

Low risk (57%) (no biopsy)

Intermediate and high risk (43%)

Target +/- Systematic biopsy

Clinical follow-up

No cancer (8%)

PCa (35%) Grade Group 1 = 25% Grade Group >1 = 75%

Active surveillance Active treatment

Figure 1: The algorithm for early detection of prostate cancer, which has been developed as part of the EAU’s new White Paper on prostate cancer

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European Urology Today

March/May 2020


The politics of clinical trials

s.collen@uroweb.org The regulatory environment surrounding clinical trials has changed rapidly over the past decades. In fact, the landscape has changed so dramatically that it is becoming increasingly challenging to perform independent clinical trials that are clinically meaningful and bring real value to patients. Several of the EAU’s networks are working to identify and address these challenges together, and we at the EAU are actively participating to bring the perspective of urology to the table. Some of the key challenges identified have been:

"As a first step, the Good Clinical Trials Collaborative reaches out to clinical trialists who have experience of the E6 Good Clinical Practice Guidelines." • How to include key stakeholders into the whole development cycle: patients and clinicians need to be at the heart of the process; • Making sure that the gap from market approval of a new drug to real-life clinical practice is addressed; • Re-engineering the process in such a way that it truly serves the needs of patients and generates the data needed to inform clinical practice;

This study, published in March 2020, highlights some key issues to be dealt with in terms of promoting more patient–centred research in Europe. It can be read via www.europarl.europa.eu/RegData/etudes/ STUD/2020/641511/EPRS_STU(2020)641511_EN.pdf. Facilitate patient safety In parallel, the European Hematology Association (EHA), an active member of the BioMed Alliance, brought key stakeholders, including the EAU, around the table to discuss bureaucratic obstacles in clinical research. One of the outcomes of this roundtable was the article Reducing Bureaucracy in Clinical Research: A Call for Action published in the open-access journal HemaSphere. This article describes the major issues that were identified by the attendees. EHA also held meetings with the regulator, the European Medicines Agency, to be informed about the challenges and to be supportive of the multi-stakeholder engagement and discussion.

Urgency

12

of Urology

urinary The disease, urological incontinence in MS patients treatment and therapeutic guidelines

Vol. 32 No.1

- January/Feb

The Europea

Dr. S. Charalampous

ruary 2020

n robotic curriculu How do you prepare m fellowsh to get the most ip out of it

The upcoming 35th Annual EAU is its Plenary Sessions. In this Congress (EAU20) will bring article, seven practice-changing respected and prominent urologists,updates to the forefront when it commence who will chair s in Amsterdam the sessions, this March. One offer a glimpse of the exemplary of the novel scientific content that constitute elements of EAU20’s the Plenary Sessions. Scientific Programm e

New frontie rs in infections

Dr. John Heesakker s (NL), Plenary New frontiers Session 1: in infections, 21 March Views on the diagnosis and treatment of tract infections urinary (UTIs) substantial country. In some, ly vary the use of antibiotics per treatment is extensive in UTI and tailor-mad patient. In others, e to the on the restriction disease management is based of antibiotics antibiotic resistance. usage to overcome

Modern PCa imaging in daily practice

LUTS and storag e symptoms

The role of innovation in stone mana gement

Dr. Jochen Walz (FR), Plenary prostate Session

3: Modern cancer imaging in daily practice, Prof. Jean-Nicol as 22 March Bladder dysfunctioCornu (FR), Plenary Session Modern imaging is Prof. Thomas prostatic disease, n, storage symptoms and 6: how we diagnose substantially changing the Knoll (DE), benign The 23 March way role of innovation Plenary Session 7 Stones: Multiparametric and treat prostate cancer (PCa). , 24 March MRI improved Lower urinary disease but the the tract symptoms new MRI pathways detection of the The removal include storage (LUTS) in men problems, i.e. of stones, which often symptoms (e.g. decisions to biopsy generate new is a daily business most urologists, and/or nocturia. overactive bladder) favour treatment or whether to is for Whilst the underlying or surveillanc has shifted from driven by innovation. Treatment pathophysiology and put into e need to be What are the open and shock context of adapted consequences endoscopic wave is more understood non-neurogenic storage such as biomarkers with regard to new developme of these contrasting assessments? symptoms percutaneo approaches; and ureteroscolithotripsy to and mainly relying Is one and genomics. nts dysfunction py and possible to create better than the other? us nephrolitho on bladder , their manageme Is tomy became it guidelines on However, safety nt remains complex clinical practice. This Plenary the standard. situations concerning infections when aspects have Session will This to be respected local detail reduction of septic bacteria load prostatic obstruction is especially so when benignin resistance differ and offer answers address these issues in for the and antibiotic complications is present. Mixed from pressure or antibiotic on how imaging such as intrarenal also a major integrated in Session will investigateregion to region? This symptoms cause can be new prophylaxis. are which are a daily of persistent LUTS after to find the answers Plenary decision-making. clinical pathways and clinical questions. surgery challenge for to these Since fluoroscop the urologist. y modality, radiationis used as a standard imaging The discussants Moreover, molecular will deliver key imaging provides and the surgical safety includes both the how to identify practical messages improvements patient substantial team. The second the symptoms in detection and on Session and logical origin. part of disease. The will determine Through real-life rule out a neurochallenge is how location of recurrent when and if new the Plenary ballistic lithotripter discuss the best cases, panels information into to integrate lasers, will medical treatment the clinical decision-m this will be followed s, and scopes are required. bladder (OAB) stratification. for overactive This aking and risk by a round-tabl in men; the best Perhaps experts on a option between ablative will be the solution the use of artificial intelligence challenging stone e deliberation among resection, vaporizatio surgical Plenary Session case. and aquablatio will give answers in the future. The last presentatio 7 n in case of concomitann, enucleation to this hypothesis n symptoms intervention to will raise your knowledge t storage . on stone and proven obstruction the next level. Don’t miss it! about minimally ; invasive, day-case and an update surgical strategies.

• Finding ways of ridding clinical trials of unnecessary red tape, which is not benefiting the patients involved; • The need for patients and clinical researchers to be more involved in the formulation of informed consent forms and guidance documents for safety reporting and other aspects of clinical studies. The European Organisation for Research and Treatment of Cancer (EORTC), which chairs the BioMed Alliance task force on clinical trials, has launched a manifesto on treatment optimisation, which picks up on many of the issues addressed above. The BioMed Alliance is a network which the EAU is a member of, represented by Prof. Hein Van Poppel (BE). It assists its members in making their voice heard to the European Union about policies and regulations that impact their work. The manifesto led to a joint study commissioned by the Directorate-General for Parliamentary Research Services of the Secretariat of the European Parliament.

of the Europ ean Association

Prof. M. Wirth after 16 years says goodbye

EAU Executive responsible for and Communica Finance tions

EAU20: Eur 27 ope’s finest Novel scien in urology tific updates to expect at premieres the Plenary in Amsterda Sessions m Dr. J. Vicente

EAU and its network address key challenges of independent clinical trials Mrs. Sarah Collen EAU Policy Coordinator Brussels (BE)

European U rology Toda y

Official news letter

2

Testis cance r and surgical andro logy

If complicatio n cases came to court. ..

Challenges across the BCa spect rum

Dr. Maarten Albersen (BE), Plenary Session #Testis cancer 2: and surgical andrology, 21 March Plenary Session 2 will kickstart andrology and with updates on surgical a review of the new Guidelines on Peyronie’s disease. 2020 EAU focus on diseases The session will that dysgenesis syndrome, result from the testicular also and review Mr. Tim O’Brien carcinoma in situ, and invasive the links with fertility, (GB), Plenary Nightmare on Session 4: addition, the testicular cancer. robotics, 22 esteemed Prof. In Prof. Morgan March Kyle Orwig present pioneering Rouprêt (FR), research in fertility (US) will Plenary Session Challenges across Plenary Session preservation. 5: the spectrum 4 23 March of bladder cancer, robotic surgery will explore the complicatio To reduce treatment ns of through the prism burden in testis Leading medico-leg Plenary Session of the law courts. cancer, the will explore the The landscape back for his fourth al lawyer, Mr. Bertie Leigh micro RNAs in promising role for novelties (GB), is has patient EAU congress of in bladder cancer urologists accountabl not changed and ready case-based discussion selection, and conduct (BCa) as a e for their decisions. to hold years. Molecular quickly as it did in the past complex retroperito on the role of robotic-ass few pathway, description isted neal surgery. biological mechanism The session will of new feature three s, markers in and several drugs scenarios: Should proceed to perform blood and urine, in the pipeline I open surgery extremely appealing. make this topic failure during after machine robotic-assisted (RARP)? Was radical prostatecto I ready We aim to find cava (IVC) surgery for the transition to inferior my more solutions to challenges responsible for in renal cell carcinoma? Who vena preservation, personalise table-side errors? is d medicine, proper in organ tools, a wise indication of usage of cystectomy, follow-up schedule, and The Plenary Session implementation will be raw and the manageme of immunoth entertaining. likely, erapy nt It will of local and locally-adv in decision-making, challenge assumptions anced BCa. concerning consent and BCa is at the safety during crossroads of surgery. endoscopic minimally invasive January/February surgery; the use , open and generations of of new 2020 drugs such as immunotherapy; medical strategy and development.

The EAU has also learned of an important and complementary project called the Good Clinical Trials Collaborative, which is led by Prof. Martin Landray (GB) and funded by the Wellcome Trust, the Gates Foundation and the African Academy of Sciences. The main aim is to support clinical trialists, reducing unnecessary burdens and getting results that matter for patients and health systems. This project focusses on good clinical practice (GCP) and the ICH Good Clinical Practice Guidelines (E6), which are up for revision. It hopes to provide input into this revision process, but also to provide a rational interpretation of GCP that will facilitate good quality, ethical clinical trials which are less burdensome, and positive outcomes for patients and patient safety.

"…re-engineering the process in such a way that it truly serves the needs of patients." As a first step, the Good Clinical Trials Collaborative reaches out to clinical trialists from all specialties and from across the globe who have experience of the E6 Good Clinical Practice Guidelines. The project team will start by mapping elements which have been supportive of good clinical practice, and those which have been less so.

You are invit

ed!

Join us for the Opening Ceremo on Friday 20 ny March, 18.00-1 9.30, in eURO Auditor ium 1*

*) Including prestigio

us EAU Awards

The Opening Ceremony will be followed by a Networki ng Reception in the foyer of eURO Auditoriu m 1 until 21.00 hrs.

www.eau20.org

More informat

ion on page

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European Urology Today

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Notification:

Promoting your (online) activities Also in these times of COVID-19, the EAU executive is pleased to help promote any scientific (online) activities. Due to the large number of requests we received in the past, we have been forced to set up some rules and regulations related to the circulation of promotional material. All EAU-related activities and activities from national societies with which we have a special alliance, may be promoted by e-mail (e-mail newsletter or separate e-mail communication), in addition to the other available channels. All other urological activities may be included in our Uroweb online calendar. Please feel free to contact us (EUT@uroweb. org) in case there are any queries or remarks related to this notice.

Any EAU member who would like to be more involved in the policy work on clinical trials, particularly anyone with relevant experience of the Good Clinical Practice guidelines, please send an email to s.collen@uroweb.org.

COVID-19 postpones changes in rules on medical devices Familiarise yourself with what to expect in a year By Sarah Collen, EAU Policy Coordinator On 26 May 2020, a new piece of EU legislation on medical devices was due to be implemented across the European Union, but the European Commission has approved a proposal to delay implementation until 26 May 2021 due to the COVID-19 crisis. With the healthcare industry rightly diverting resources and attention to respond to COVID-19, now is not the time to change the rules. In order to maintain a steady supply of medical equipment, it was not deemed appropriate to move to the new set of rules immediately. The implementation schedule of an accompanying regulation on in vitro diagnostic medical devices (IVDs), a regulation due to be implemented in 2022, will remain unaffected. For those who have not yet heard of the new law, the following is a short summary of what are the top changes to be expected by clinicians when the rules are implemented in May 2021. ‘Medical device’ is defined in the new rules as any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for medical purposes. Most of the changes will apply to the industry manufacturing the devices to put on the EU market. However, the legislation will also have an impact on health care providers as either users of the products or as those who produce or modify devices to help specific patient groups in their care. For the first time, there will be a key role for clinical experts to provide an independent opinion during the assessment of high-risk devices before certification/approval by the regulators. These experts will also be involved in other tasks, such as contributing to the development of common specifications for clinical evaluation of device categories, guidance documents, or standards. The EAU has responded on this in partnership with the BioMed Alliance: a network of medical and scientific organisations working together at EU level. Prof. Evangelos Liatsikos (GR), ESU chair March/May 2020

elect, participates in the Medical Device Regulation discussions on behalf of the EAU. Key changes on the horizon for clinicians In particular clinicians may want to ensure they are well informed and prepared for how their organisation/country will be implementing the following:

"In particular clinicians may want to ensure they are well informed and prepared for the changes." Health institution exemption (Article 5 of the Medical Device Regulation, MDR): Devices that are manufactured or modified and used within health institutions shall be considered as having been put into service. These may be devices that are used on specific patient groups inside the health institution when alternatives do not exist on the market. An example of this may be the modification of the software in an MRI scanner to better read a certain type of tumour. Previously, such in-house manufacture and use was not covered systematically across the EU. In the future, it will be. The full requirements for medical devices shall not apply to these devices provided that certain conditions are met, including: • The health institution ensures that the relevant general safety and performance requirements, which can be found in Annex 1 of the regulation, are followed; • An appropriate quality management system is established within the healthcare setting; • Justification is made for why the target patient group’s specific needs cannot be met by an equivalent device on the market; • Information is made available to competent authorities on request; • A declaration with certain details is made publicly available;

• Clinical use of the devices in question is reviewed and all necessary corrective actions are performed. Clinicians working with in-house laboratories or clinical engineering departments to modify or manufacture any devices for a particular group of patients will need to apply these rules in a year’s time, so it would be good to already familiarise yourself with the changes. Your hospital or healthcare provider may have a designated person to whom you could direct your comments on this new legislation. Implant cards (Article 18 of MDR): Healthcare providers will need to provide patients with implantable devices with an implant card, which shall bear the patient’s identity, as well as rapid access to certain information, including: • The identification of the device, including the device name, serial number, lot number, the UDI (Unique Device Identification), the device model, and the name, address and website of the manufacturer; • Warnings, precautions or measures to be taken by the patient or a healthcare professional;

• The expected lifetime of the device and any necessary follow-up. Clinicians will need to familiarise themselves with the changes suggested by their organisation. Unique Device Identification (Article 27 of MDR): The UDI system will allow for safety alerts, potential recalls, as well as more general surveillance tasks. For Class III implantable medical devices, health institutions will need to store and keep (preferably by electronic means) the UDI of the devices which they have supplied or with which they have been supplied. Health institutions may be required to do this for other devices as well, depending on further implementation decided by the European Commission. The UDI system requirement will apply to class III and implantable devices in May 2021. In many settings, this is likely to mean that the codes need to be scanned or entered manually into the hospital IT system by clinicians before use. The full text of the medical devices regulation can be found via www.ec.europa.eu/growth/sectors/ medical-devices_en.

©European Commission

European Urology Today

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New techniques, technology, strategies and surgeons ERUS-DRUS20 looks ahead to robotic surgery in 2030 These are difficult times and many of us have to focus on other things than upcoming meetings. Despite the current situation we would like to draw your attention to the combined ERUS/DRUS meeting in Düsseldorf on 5-7 November. This will mark the first time that the EAU Robotic Urology Section (ERUS) meeting will be held together with the German Robotic Urology Symposium (DRUS). It will be hosted by Prof. Alex Mottrie (ERUS Chairman and the meeting’s Scientific Director), Prof. Michael Stoeckle (Chairman of the German Society for Robot-assisted Urology) and myself as Director of the Host Faculty for ERUS-DRUS20. The meeting will focus on the challenges in urology in this decade and will provide the participants with the latest information about surgical techniques, new technology, and up-to-date oncologic strategies, and it will introduce new surgeons. As in previous years the programme will be a balanced mixture of live surgery and cutting-edge scientific presentations and discussions.

Register now for the early fee! Deadline: 4 August 2020

Submit your abstract now! Deadline: 1 July 2020

Dr. Jörn H. Witt Director Host Faculty, ERUS-DRUS20 Gronau (DE)

COVID-19. By the end of the year we hope that the meeting can be held without constraints. In case of continued restrictions, the congress organisation will be prepared for additional options like online participation or more space between the seats (depending on the requirements).

Join the combined ERUS-DRUS20 meeting this November in Düsseldorf, Germany for one of the largest and exciting Urology meetings this year! Stay healthy and keep your distance! Keep an eye on www.ERUS20.org for the Scientific Programme and further details.

experienced surgeons will be introduced and will demonstrate their techniques. ERUS and DRUS are also involving more female surgeons in the programme. Other procedures that will feature include adrenalectomy, pyeloplasty, ureter replacement, sacrocolpopexy, prostate adenomectomy and bladder neck reconstruction. A renal donor explantation and transplantation will be broadcast from the University of Homburg/Saar. A single-port partial nephrectomy with the Da Vinci SP system, which is not yet approved in Europe will be transmitted from Chicago, USA.

One other highlight of the meeting will be live and The surgeries will be performed at the St. Antonius semi live surgeries with the newly approved robots Hospital in Gronau, equipped with five Da Vinci robots from a variety of companies. Companies will have an and a large surgical programme of about 2000 cases opportunity to demonstrate their products and give per year. The faculty will include the most experienced an update about their current product development at German, European and worldwide surgeons in their the Technology Forum. field. Included in the meeting will be the Junior ERUS-YAU Scientific Programme Highlights meeting with special discount rates for young One major topic at ERUS-DRUS20 will be current urologists as well as best poster and best video development in oncologic surgical techniques for prizes. A special EAUN meeting for nurses will be prostate, renal and bladder cancer. After almost 20 included, as will an additional German language years of robotic surgery, many techniques have meeting for nurses. Participants can also expect evolved far beyond the possibilities of open or courses by the European School of Urology. laparoscopic surgery. The newest strategies for optimised oncological and functional results will be Many scientific meetings, including live surgery demonstrated and discussed. Young, but already meetings have been cancelled this year due to

Urology staff of the St. Antonius Hospital in Gronau (DE) where the live surgery will be performed

Robotic Live Surgery

ERUS-DRUS20 17th Meeting of the EAU Robotic Urology Section in conjunction with the 12th meeting of the German Society of Robotic Urology 5-7 November 2020, Dusseldorf, Germany

www.erus20.org

Join us!

21-25 SEPTEMBER Urology Week is an initiative of the European Association of Urology, which brings together national urological societies, urology practitioners, nurses and patient groups to create awareness of urological conditions among the general public.

urologyweek.org 30

European Urology Today

#urologyweek March/May 2020


ELUTS20: A myriad of uro-subspecialties Meeting delivers new info on LUTS, SUI, POP and more Enrich your knowledge on a myriad of urological subspecialties at the upcoming 4th edition of the European Lower Urinary Tract Symptoms (ELUTS20) meeting which will take place in Barcelona, Spain from 30 to 31 October 2020.

Masterclass coverage The first part of the ESU-ESFFU Masterclass on Functional Urology in Clinical Practice will kickstart on 29 October, a day before ELUTS20, and will continue in the afternoon of 30 October.

The latest ELUTS meeting is a synergy of support and expert contributions from the European Association of Urology (EAU), the International Continence Society (ICS), the EAU Section of Female and Functional Urology (ESFFU), and the European School of Urology (ESU).

Under the guidance and expertise of Dr. Heesakkers, the masterclass will include presentations on male and female anatomy, neuroanatomy, physiology, bladder pain syndrome, and sexual dysfunction to name a few. The programme will constitute of patient cases submitted by the participants and faculty, as well as, various informative videos. The latter will include step-by-step videos of sacral nerve stimulation (SNS) and augmentation with regard to surgery management of overactive bladder (OAB); complications videos e.g. solving a bladder erosion of tapes; and other videos which will cover urodynamics, operation of vesicovaginal fistula (VVF), demonstrations of advance slings and robotic sacrocolpopexy, and more.

The ELUTS20 faculty will comprise of renowned key opinion leaders such as EAU Secretary General Prof. Chris Chapple (GB), ICS General Secretary Prof. Dr. David Manuel Castro Díaz (ES), ICS Developing World Committee Chair Prof. Sherif Mourad (EG), Chairman of the ESFFU Prof. Francisco Cruz (PT), and Dr. John Heesakkers (NL) from the Scientific Office. According to Prof. Cruz, the ELUTS20 Scientific Programme is an amalgamation of vital updates, proven and innovative strategies and techniques. “The meeting will offer insights on practical approaches in handling lower urinary tract symptoms (LUTS), male and female stress urinary incontinence (SUI). We will examine real-life cases to gain insight on what is the most effective in which situation. The Scientific Programme will also include viewing of surgical videos in a step-by step format to facilitate the learning of tips and tricks. Intense debates when addressing challenges and potential complications are expected.” Prof. Cruz added, “Participants can look forward to meeting highlights such as new developments in pharmacological treatment of LUTS, particularly for elderly patients; discussions on the usage of botulinum toxin A by neurogenic patients and how it compares to bladder augmentation; and new information on treatment of pelvic organ prolapses (POP).”

ELUTS20 launches ELUTS20 will commence with recent developments in functional and female urology, followed by new updates in male incontinence, neuromodulation, and urinary tract infection (UTI) prophylaxis. Delegates and faculty alike will deliberate on the necessity of urodynamics prior to invasive LUTS treatments. Participants can expect lively discussions during the case presentations on male LUTS and normal-pressure hydrocephalus, female SUI, transvaginal and transabdominal repairs concerning mesh. ELUTS20 will also offer essentials in the examination of female patients with SUI and/or POP; treatment of menopausal genito-urinary syndrome; caring for geriatric patients with POP; identification and management of common complications after SUI and POP surgeries.

Final-day programme After the interactive neuro-urology update on botulinum toxin A and bladder augmentation, the Challenging the Guidelines segment will centre on the "non-index" patient with SUI, interstitial cystitis (IC)/ bladder pain syndrome (BPS), and male LUTS.

Register now for the early fee! Deadline: 29 July 2020 Also at the meeting, participants will have the opportunity to watch videos which showcase step-by-step procedures on autologous pubovaginal sling; laparoscopic and robotic colposuspension, sacrocolpopexy, and artificial urinary sphincter (AUS) in female patients; and arterial embolization for benign prostatic hyperplasia. The multifaceted meeting will conclude with lectures on the role of urodynamics, maximisation of conservative management, nocturia management,

treatment of antimuscarinic load and cognitive problems, and the outcomes of transurethral resection of the prostate (TURP) in detrusor underactivity and neurological patients. Join us at ELUTS20 Submit your abstract for the opportunity to present your original research to your peers. Send in your abstract via abstracts.uroweb.org before 1 September 2020. Another way to join ELUTS20 is to sign up as a participant. Take advantage of special rates of the early fee by registering via www.eluts20.org before 29 July 2020. ELUTS20 has a dynamic programme with wellrounded treatment approaches and a contemporary take on traditional procedures. What more can you ask for? We look forward to welcoming you in Barcelona. See you at ELUTS20!

ELUTS20 European Lower Urinary Tract Symptoms meeting 30-31 October 2020 Barcelona, Spain By

www.eluts20.org

Activities of day two will also include poster and video presentations.

In collaboration with

12th EMUC celebrates longstanding ties between societies Collaboration extends beyond multidisciplinary congress to include joint guidelines The EAU, the European Society for Medical Oncology (ESMO) and the European SocieTy for Radiotherapy & Oncology (ESTRO) are making plans for EMUC20, the 12th European Multidisciplinary Congress on Urological Cancers. The congress is set to take place in Athens, Greece on 12-15 November and is one of the biggest events in the urological calendar. We spoke to Prof. Arnulf Stenzl (Tübingen, DE) who sits on the EMUC Organising Steering Committee on behalf of the EAU, about hot topics in onco-urology that delegates can expect to learn about, about how EMUC is innovating its scientific programme, and how the current COVID-19 pandemic is affecting oncourological care. The Scientific Programme The four-day EMUC20 Scientific Programme is comprehensive in its field. The first day features optional and supplemental programmes (including the EAU Section of Urological Imaging’s annual section meeting) that require additional registration or fees. The regular EMUC scientific programme starts on 13 November. Major topics include presentations and case discussions on prostate cancer, bladder cancer, new trials and all other GU cancer, all featuring speakers with perspectives and expertise from their own disciplines.

Abstract submission now open! Deadline: 1 July 2020 Prof. Stenzl points out some highlights for 2020: “we are covering new approaches in the comprehensive treatment of non-muscle invasive bladder cancer, the treatment of urothelial and prostate cancer, particularly checkpoint inhibitors in various combinations”. In order to better highlight the multidisciplinary character of the congress, when it comes to certain March/May 2020

case discussions the scientific committee has decided to include more discussants. Each discussant will address the case at hand from a different treatment perspective. This way, each approach to the treatment can be compared and weighed appropriately.

Register now for the early fee! Deadline: 12 August 2020 The COVID-19 pandemic that has so drastically impacted life for everyone also affects the management of patients of urological cancers. Prof. Stenzl points to an entire session that has been added to the programme in the wake of the pandemic: “There will be a new session in the EMUC20 scientific programme that addresses the pandemic’s influence on treatment of onco-urological patients. We will be covering new guidelines that were set up by, among others, the EAU’s Guidelines Office Rapid Reaction Group (GORRG).”

“There will be a new session in the EMUC20 scientific programme that addresses the pandemic’s influence on treatment of onco-urological patients." The GORRG is one of several guidelines initiatives to offer additional recommendations on safety for patients and medical professionals. The recommendations can be found on the EAU website at https://uroweb.org/covid19-resources-forurologists/initiatives. At the time of writing (late April) EMUC20 is still set to be held, although the organisers are closely monitoring the situation. A longstanding cooperation The first EMUC was held in 2007, initially as a biannual meeting. In its first four iterations it was

held in Barcelona. From 2011, the congress was held on an annual basis, and it soon started being held beyond Barcelona. In 2019, EMUC was held in Vienna. The congress has expanded over the years to include more oncology-related fields, such as the EAU Section of Urological Imaging and satellite sessions that cover pathology, as well as countless (hands-on training) courses by the European School of Urology. But at the core of EMUC was always the cooperation between the EAU, ESMO and ESTRO, a multidisciplinary organisation for a multidisciplinary approach to urological cancers.

For the complete Scientific Programme visit www.emuc20.org Prof. Stenzl characterises the cooperation with fellow Steering Committee members Profs. Aristoteles Bamias (Athens, GR) and Peter Hoskin (Northwood, GB) as “very pleasant and on a basis of collegiality, with understanding and fruitful discussions. Our combined projects, like guidelines, go beyond the scope of the congress and benefit all disciplines.” For the latest information on the Scientific Programme please visit: www.emuc20.org/scientific-programme/

12-15 November 2020, Athens, Greece

Implementing multidisciplinary strategies in genito-urinary cancers 12th European Multidisciplinary Congress on Urological Cancers In conjunction with the • 9th Meeting on the EAU Section on Urological Imaging (ESUI) • European School of Urology (ESU) • EMUC Symposium on Genitourinary Pathology and Molecular Diagnostics (ESUP) • Young Academic Urologists Meeting (YAU)

www.emuc20.org

European Urology Today

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www.esgurs20.org

EAU Update on Prostate Cancer

12 -13 September 2020 Madrid, Spain

ESGURS20 EAU onco-urology series

12th Meeting of the EAU Section of Genito-Urinary Reconstructive Surgeons

www.pca20.org

8-9 October 2020, Madrid, Spain An application has been made to the EACCMEÂŽ for CME accreditation of this event

www.esui20.org

New EAU Guidelines 2020 available online!

ESUI20 9th Meeting of the EAU Section of Urological Imaging

To order in a printed format on request, free of charge for members (postage costs will apply) by contacting: eaureception@uroweb.org

12 November 2020, Athens, Greece In conjunction with the 12th European Multidisciplinary Congress on Urological Cancers

An application has been made to the EACCMEÂŽ for CME accreditation of this event

Eu ro pea n A ssociation of Urology

Guidelines 2020 edition

Follow us on #eauguidelines or Facebook

32

European Urology Today

March/May 2020


Animated videos - An embedded tool in patient information Evidence-based online information for patients in the age of the internet Ms. Patricia Chang EAU Patient Information Coordinator Arnhem (NL)

English being the main language, providing a wide range of urological topics. Visitors to the website can download printable leaflets and watch a number of animated videos about treatments, tests and surgical procedures.

p.chang@ uroweb.org

EAU Patient Information contributes to reliable and evidence-based information on the internet and social media by making its animated videos available on YouTube and Facebook. These animated videos are successfully watched as proven by the hundreds and thousands of views on the internet and social media.

Many patients turn to the internet as this is a fast and easy way to search for medical information. The internet allows for low-threshold opportunities to disseminate information about health and medicine as well as creating a platform for psychological and moral support. However, studies show that medical information available on the internet can be inaccurate, misleading and even harmful.

“HCP’s are more than welcome to use and disseminate EAU Patient Information’s animated videos.” Reliable and evidence-based information for patients Since its establishment in 2012, EAU Patient Information has developed various information tools to help educate urology patients. A dedicated Working Group consisting of fourteen urologists, two specialist nurses, and one uropathologist from a variety of European countries are responsible for the development of evidencebased patient information. On EAU Patient Information’s expanded website (patients.uroweb.org), visitors can find detailed information about urological cancers, other urological diseases, tests, treatments and tips on urology health. The website offers several European languages, with

The following animated videos can be found in EAU Patient Information’s YouTube playlist: Topics Languages Changing stoma bag English, German, Russian Cystectomy English, Russian Cystoscopy English, Russian Double J-stent placement English, German, Russian Drug treatment for OAB English, Russian PCNL English, German, Russian SWL English, Russian URS Chinese, English, German, Russian, Spanish, Turkish Urodynamic testing English, Russian In December 2019, EAU Patient Information’s animated videos reached a number of 400,000 views on its YouTube (360K views) and Facebook (40K views) accounts since their 2-year and 1-year existences respectively on the internet. The top-3 videos on YouTube were: Double J-stent (English- 146K views), URS (English-72K views), and SWL (English-52K views), followed by PCNL (English-27K views) and URS (Spanish26K views). Anatomy of the animated video All animated videos start with a voice announcing which procedure will be shown. Visuals with captions highlight the organs and parts of the

Focus gives you... Insight

organs in the body that are involved. The function and workings of organs are explained as well as the steps of the medical test, treatment or surgical procedure. Video length varies from approximately two to three minutes. Expected videos EAU Patient Information and its Working Group have begun developing additional animated videos. These include videos about robot-assisted cystectomy, robot-assisted partial nephrectomy, and robot-assisted radical prostatectomy. The release of two more videos is expected shortly, i.e. ‘BPE: Causes & symptoms’ and ‘Erectile dysfunction as a co-morbidity.’ The videos will be made available on patients.uroweb.org, YouTube and Facebook.

Shout out to HCP’s EAU Patient Information wants to help educate patients by providing information tools such as the animated videos. Videos explaining tests, treatments and surgical procedures improve patients’ understanding and enhance their involvement and engagement in their medical journey. HCP’s are more than welcome to use and disseminate EAU Patient Information’s animated videos. Questions or interested? For more information about our animated videos or other patient topics, or if you have ideas for improving our patient information, please contact us through e-mail at info.patientinformation@uroweb.org. Visit our website (patients.uroweb.org) and follow us on Twitter (@EauPatient) and Facebook (EAUPatientInformation).

Apply for your EAU membership online!

Becoming an EAU member now is fast and easy! With high-quality, high-impact primary research articles

In a matter of minutes, you can be part of the fast-growing, international community of healthcare professionals from within and beyond Europe. Sign up now to enjoy all the benefits the EAU membership can offer! Simply go to www.uroweb.org/membership and click on Membership to receive the best practices and the latest developments in urological research and care. Be an EAU member now!

www.uroweb.org Research through a new lens

March/May 2020

European Urology Today

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Be Involved in an EAUN Special Interest Group The purpose of SIG groups is to support networking between members and provide a forum/think tank for nurses with a special interest or knowledge about specific urological issues. Here they can exchange experiences and investigate urological nursing issues related to the topic of their group.

Fellowship Programme European Association of Urology Nurses

SIGs support the EAUN board with their expertise on topics such as Prostate cancer, Bladder cancer, Incontinence or Endourology. They advise on guidelines, lectures, speakers, enquiries from members, EAU offices, other societies or companies, write articles in the EAUN newsletter, and more. Together, they build up a network and enhance their own knowledge simultaneously.

Continence SIG

Bladder Cancer SIG

Prostate Cancer SIG

Endourology SIG

SIG Structure • A SIG is formed by nurses (or other health care professionals) with special experiences in one particular part of the urology field • Every SIG will have a chair who acts as the connector between the group and the EAUN board, with yearly reports highlighting ideas and outcomes • SIGs work autonomously and have the freedom to pursue relevant topics • There is not a specific term for being a member of a group, nor is membership restricted to one group • SIG members can be invited based on information in our membership database, they can apply themselves, or they can be invited by the SIG chair or EAUN board members • As all members are volunteers, there is no obligation to participate in every project the group decides to start

SIG Activities • Video meetings at least once a year and when preparing activities arranged by the EAUN office • Provide a thematic session at the Annual International EAUN Meeting • Provide articles or contact authors to publish in European Urology Today or other journals • Support the EAUN with potential sponsors • Support the ESUN courses • Support Guideline Groups • Any other activity the group may want to undertake

www.eaun.uroweb.org/special-interest-groups-sigs/

Take the free e-course - EAUN members only

Visit a hospital abroad! 1 or 2 weeks - expenses paid Application deadline: 31 August 2020 • Only EAUN members can apply • Host hospitals in Belgium, Denmark, France, the Netherlands, Sweden, Switzerland and the United Kingdom • A great way of widening your horizon European Association of Urology Nurses

For Fellowship application forms, rules and regulations and information on which specialities the hosting hospitals can offer please visit the EAUN website. T +31 (0)26 389 0680 F +31 (0)26 389 0674 eaun@uroweb.org www.eaun.uroweb.org

First Announcement

Sexual dysfunction in men and women 5th Course of the European School of Urology Nursing

Preventing catheter-associated urinary infection

Your role in prevention is crucial! Developed by Ms. Dinah Gould and Accredited by the Royal College of Nursing Through this e-course, you will... • Understand why UTIs and CAUTIs are common • Learn the indications for urethral catheterisation (UC) • Determine the risk factors for CAUTIs • Define the strategies to prevent CAUTIs and catheter-related complications • Critically evaluate the guidelines on preventing CAUTIs • Learn to determine whether long-term UC is appropriate for a patient 1-hour e-course including a pre-test and a post-test. A certificate is provided after completion.

Take the free online course where and when it suits you!

Simultaneously held with the ESU-ESAU-ESGURS Masterclass on Erectile restoration and Peyronie’s disease 1-2 October 2020, Leuven, Belgium

Join us at the 5th ESUN Course in Leuven

30 places available

Do you know that sexual issues can affect any patient at any time? What do you really know about sexual dysfunction/issues? Are you able to talk to your patient? Do you know how to start or open the conversation? Do you know what to say? Would you like to be better at it? Regardless of your answer, you’ll want to join us for the 5th ESUN Course in Leuven in October 2020 to know more. As a nurse, the patients you support may need advice or guidance on those intimate issues and don’t always get it. The course will combine theory and practice and includes workshops. The preliminary programme consists of the following modules: Module 1:

The physiology of human sexual function

Module 2:

Female sexual disorders (FSD): Pathology and challenges in medical treatments

Module 3:

Male sexual disorders

Module 4:

Counselling in sexual disorder in men and women

Module 5:

Treatment of erectile dysfunction

Workshop 1:

Surgical treatment: Penile prosthesis

Workshop 2:

Let’s talk about sex

Live surgery:

Various live surgery sessions together with the participants of the ESU Masterclass on Erectile restoration and Peyronie’s disease

When registration is open please send an email to c.vanijzendoorn@ congressconsultants.com to receive an application form. Selection will take place based on experience, work environment and educational background. For more information please visit www.eaun.uroweb.org. We are looking forward to receiving your email!

The Organising Committee: Corinne Tillier (NL), Jason Alcorn (GB), Jeannette Verkerk (NL) An application will be made for accreditation by the Dutch nurses accrediting bodies.

Registration fee for the course is €100 for EAUN members and €135 for non-EAUN members. The EAUN covers your hotel arrangement for one night and reimburses your flight (max. €500), train ticket or km costs car travel.

Send an email to eaun@uroweb.org to receive login details. Only EAUN members can apply!

34

European Urology Today

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The quality and use of communication in PCa decision aids Results from a large-scale systematic review assessing 19 tools for localised PCa patients

r.d.vromans@ tilburguniversity.edu Men newly diagnosed with localised prostate cancer are facing difficult decisions regarding their treatment. They need to choose from a range of treatment options (e.g., surgery, external beam radiotherapy, brachytherapy, or active surveillance), which have equivalent survival outcomes but differ in the risk of adverse events1,2. In the process of shared decision making, decision aids (web-based tools) provide information about treatment options and associated risks of side effects, and help patients get to know their values and preferences3. Today, there are many patient decision aids available for prostate cancer patients, and according to a large Cochrane review, they seem to be effective4. However, what is their quality? And to which extent do decision aids pay attention to communication features? Large-scale systematic review To answer these questions, a group of Dutch (health communication) scholars recently performed a large-scale systematic review to assess the quality and use of communication in currently available decision aids for patients with localised prostate cancer. They systematically searched through academic databases such as EMBASE or MEDLINE to collect decision aids that were, for instance, part of interventions in randomised controlled trials. In addition, they performed a thorough search through Google, since patients are more likely to find their information and decision aids in this environment5.

Eventually, they identified 19 international decision aids, of which 11 originated from North America and eight from Europe. The majority of the aids (12) were web-based tools, and the year of publication ranged from 2007-2018. IPDAS checklist The authors first assessed the quality of the tools by using the validated International Patient Decision Aids Standards (IPDAS) checklist6, which covers a variety of quality dimensions, ranging from evidence-based information about treatment options and outcome probabilities to decision guidance and development process. The authors found that the quality varied greatly across the decision aids, with many failing to comply with all components of the IPDAS criteria (mean IPDAS score = 59%, range = 36%-84%). This is also shown in Figure 1A, in which there is large variability for many IPDAS dimensions. Many aids did not adhere to good practice guidance on the presentation of outcome probabilities associated with treatment options, and lacked substantial information regarding the development process and readability levels of the aids. Communicative Aspects checklist After the quality assessment, the authors further reviewed the decision aids regarding their use of communication for which they developed the Communicative Aspects (CA) checklist7,8. This tumour-independent checklist consists of 76 items divided into seven aspects: Information Presentation (e.g., how risks and uncertainties were communicated), Personalisation (e.g., how treatment information was tailored to patient characteristics), Interaction (e.g., how patients’ personal values and preferences were clarified), Information Control (e.g., how patients had control over access to and amount of information), Accessibility (e.g., whether the tool was easily accessible), Suitability (e.g., how suitable and understandable the content was) and finally Source of Information (e.g., whether and how the source of treatment information was given).

Figure 1: Quality (A) and use of communication aspects (B) of the 19 international decision aids for prostate cancer treatment. Within each IPDAS dimension or CA aspect, each dot represents one decision aid

Results The authors observed substantial variations in use of communication in decision aids (Figure 1B), with a mean CA score of 51% (range 32%-64%). Most importantly, few aids used visuals to communicate outcome probabilities, and none of them were personalised in terms of communicating the likelihood of experiencing treatment side effects. Furthermore, only a minority of the aids used interactive exercises to elicit patients’ values and preferences, and most tools had biased cross tables to compare the pros and cons of treatment options. The authors also found some issues with the suitability and accessibility of information in the aids that may hinder the uptake of decision aids in daily clinical practice.

HYPERLINKS

Conclusion What we learn from this? According to the authors, this review demonstrates the variability among currently available decision aids for localised prostate cancer treatment, and shows that both their quality and use of communication can be improved. The authors recommend urologists who are using or developing decision aids to focus on personalisation techniques, such as communicating individualised risks of treatment side effects or tailoring the amount of treatment information to patient characteristics and preferences. Other possible improvements are the inclusion of interaction exercises for clarifying patients’ preferences and values, and using both text and visualisations for communicating statistical information. These suggestions are also relevant for clinicians outside of prostate cancer who are facing similar complex and time-consuming clinical counselling scenarios with their patients.

The International Journal of

Urological Nursing

- the official Journal of the BAUN International Journal of

Urological Nursing the journal of the baun

ISSN 1749-7701

Volume 10 • Issue 2 • July 2016

Editor Rachel Busuttil Leaver Associate Editor Jerome Marley

The International Journal of Urological Nursing is a must have for urological professionals. The journal is truly international with contributors from many countries and is an invaluable resource for urology nurses everywhere.

References 1. Hamdy FC, Donovan JL, Lane JA, et al. 10-Year outcomes after monitoring, surgery, or radiotherapy for localized

The journal welcomes contributions across the whole spectrum of urological nursing skills and knowledge:

Would you like to receive all the benefits of EAUN membership, but have no time for tedious paperwork?

• General Urology • Clinical audit • Continence care • Clinical governance • Oncology • Nurse-led services • Andrology • Reflective analysis • Stoma care • Education • Paediatric urology • Management • Men’s health • Research

Call for papers

Go to www.eaun.uroweb.org and click EAUN membership to apply online. It will only take you a couple of minutes to submit your application, the rest - is for you to enjoy!

Visit: bit.ly/2jgOqQj

Visit: www.wileyonlinelibrary.com/journal/ijun

March/May 2020

Becoming a member is now fast and easy!

16-268105

35% discount

Source: Communicative aspects of decision aids for localized prostate cancer treatment: A systematic review. Vromans RD, van Eenbergen MC, Pauws SC, Geleijnse G, van der Poel HG, van de Poll-Franse LV, Krahmer EJ. Urol Oncol Semin Orig Investig. 2019 Apr;37(7):409-429. https://doi.org/10.1016/j. urolonc.2019.04.005

Apply for your EAUN membership online!

wileyonlinelibrary.com/journal/ijun

Subscription Offer to EAUN members

prostate cancer. N Engl J Med. 2016;375(15):1415-1424. doi:10.1056/NEJMoa1606220 2. Donovan JL, Hamdy FC, Lane JA, et al. Patient-reported outcomes after monitoring, surgery, or radiotherapy for prostate cancer. J Urol. 2017;375(15):1425-1437. doi:10.1016/j.juro.2017.02.004 3. Elwyn G, Durand MA, Song J, et al. A three-talk model for shared decision making: Multistage consultation process. Bmj. 2017;359:j4891. doi:10.1136/bmj.j4891 4. Stacey D, Légaré F, Lewis K, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2017;4:CD001431. doi:10.1002/14651858. CD001431.pub5 5. van Eenbergen MCHJ, Vromans RD, Boll D, et al. Changes in internet use and wishes of cancer survivors : A comparison between 2005 and 2017. Cancer. 2019;126(2):408-415. doi:10.1002/cncr.32524 6. Elwyn G, O’Connor AM, Bennett C, et al. Assessing the quality of decision support technologies using the International Patient Decision Aid Standards instrument (IPDASi). PLoS One. 2009;4(3):e4705. doi:10.1371/journal. pone.0004705 7. Vromans RD, van Eenbergen MC, Pauws SC, et al. Communicative aspects of decision aids for localized prostate cancer treatment – A systematic review. Urol Oncol Semin Orig Investig. 2019;37(7):409-429. doi:10.1016/j.urolonc.2019.04.005 8. Vromans R, Tenfelde K, Pauws S, et al. Assessing the quality and communicative aspects of patient decision aids for early ‑stage breast cancer treatment: A systematic review. Breast Cancer Res Treat. 2019;178(1):1-15. doi:10.1007/s10549-019-05351-4

www.eaun.uroweb.org

Ruben Daniël Vromans, MA MPhil, PhD Candidate Dept. of Communication and Cognition Tilburg University (NL)

European Urology Today

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Rare and unknown: Sleep-related painful erections No adequate treatment available for unpleasant nocturnal condition Mrs. Jeannette Verkerk Nurse practitioner St. Antonius hospital Nieuwegein (NL)

j.verkerk@xs4all.nl Sleep-related painful erections are a very rare condition in men. Over the last 2 years, I have seen the condition only 4 times. No treatment Sometimes nightly erections become painful. The reason why remains unclear. Men wake up during the night because of the painful erection and cannot fall asleep again unless the erection disappears. Case studies describe that the erection sometimes starts again after lying down once again. One of the men in my practice told me the same thing. There is no well-described treatment with enough evidence behind it. There is no EAU guideline for this phenomenon. But I would like to give you some insight. I have used the PhD booklet by Dr. Sanne Vreugdenhil (NL) with great pleasure. She did her promotion on pathological erections and delivered a great overview.

polysomnography to register the REM sleep episodes and electromyography of the pelvic floor to see if it contracts. This is a costly way to diagnose the SRPE and is not performed regularly.

(NO) facilitates the relaxation of the smooth muscle and is catalysed by NO synthase. When the arteries and sinusoids fill with blood, the veins are compressed against the tunica albuginea. In the end, the arteries will also be compressed because the inner blood pressure rises to 100 mmHg. This will create a maximally erect penis. The pelvic floor muscle bulbospongiosus and ischiocavernosus muscle play an additional role in further rigidity. The exact way this works remains unclear.

In the literature, only case reports about this disease are published, with the largest cohort consisting of 24 men in the group of Dr. Mels Frank van Driel (NL). Therefore, evidence is still lacking and the understanding of the pathophysiology of SRPE is still unknown.

“There is no well-described treatment with enough evidence behind it. There is no EAU guideline for this phenomenon. But I would like to give you some insight.” Detumescence of the erection starts with the sympathetic nerve system, which stimulates contraction of the smooth muscle inside the corpora cavernosa. This pathway starts from thoracic 11th to lumbar 2nd spinal cord level. Norepinephrine is the principal neurotransmitter to maintain flaccidity and stimulate the adrenergic receptors. In figure 1, the whole neurological pathway is shown.

Sleep related erections (SRE) and REM sleep The relation between REM sleep and SRE was first described in the fifties of the last century. Sleep related erections appear throughout the lives of men, “SRPE are difficult to diagnose even when they are children. The cerebral cortex plays an essential role in the occurrence of SRE. because the patient should sleep only the brainstem is left in rats, SRE with NPT-R measuring equipment.” When disappear but the REM sleep remains intact. It is believed that intermittent nocturnal filling of the Physiology of erections corpora cavernosa provides better penile tissue The erectile process is complex and requires relaxation oxygenation. It may therefore prevent erectile of the smooth muscles in the corpora cavernosa and dysfunction by preventing fibrosis of the penile tissue. In the past, it was assumed that testosterone correct functioning of the parasympathetic plays a role in SRE. Androgens would attenuate the neurovascular bundles which arise from the 2-4th noradrenergic neurons, causing a testosteronesacral spinal cord. The neurotransmitter nitric oxide

Robotic Urology Nursing

Figure 1: Neural pathways controlling human penile erection, as taken from Pathological erections. Historical, pathophysiological and clinical aspects by Dr. Vreugdenhil

related excitatory action to manifest the SRE. It is known that the testosterone level has an important influence on the SRE. The SRE will happen more often and last longer when boys enter puberty. When hypogonadal men receive testosterone replacement therapy, the rigidity of the SRE becomes more intense, lasts longer, and happens more often. Even the level of testosterone in the blood varies from non-REM sleep to REM sleep transition. Sleep-related painful erections (SRPE) The nocturnal penile tumescence and rigidity (NPT-R) can be measured using a Rigiscan® during the night and shows about 4-6 nocturnal episodes of erections. SRPE are difficult to diagnose because the patient should sleep with NPT-R measuring equipment;

Baclofen® Several treatments have been tried over the years, but none shows very good results. Different medical treatment, such as a muscle relaxant (Baclofen®), different antidepressants, benzodiazepines, antipsychotics, anti-epileptic drugs, anti-androgens, beta-blockers, and PDE5-I, have been used. Even combinations of drugs have been tried and described in several case reports. The conclusion of Dr. Vreugdenhil et al. in their meta-analysis of SRPE is that Baclofen has the most promising efficacy and its side effects are acceptable (Vreugdenhil, 2018).

EAUN Board Chair Chair Elect Board member Board member Board member Board member Board member Board member Board member Elect

Susanne Vahr (DK) Paula Allchorne (UK) Jason Alcorn (UK) Jerome Marley (GB) Tiago Santos (PT) Corinne Tillier (NL) Jeannette Verkerk (NL) Giulia Villa (IT) Franziska Geese (CH)

www.eaun.uroweb.org

ERUS-DRUS20 ERUS-EAUN Robotic Urology Nursing Meeting 5-7 November 2020, Dusseldorf, Germany

Robotic nursing update in Dusseldorf Enhance your knowledge of techniques, patient pathway and assistant role There is no harmonised training for nurses and RNFAs at this moment and this meeting aims to fill this gap with a high quality nurses programme. The 2020 edition of the ERUS-EAUN Robotic Urology Nursing Meeting in Dusseldorf is a unique meeting for nurses and RNFAs working in robotic urology. By collaborating with EAU and ERUS we are able to provide an educational programme based on best practice with a very high standard.

Both are completely dedicated to the operating room nurse / assistant role in theory and practice and include state-of-the art lectures on low vs. high risk prostate cancer, how to interpret the MRI, nerve sparing, lymph node dissection, enhanced recovery, amongst others. Team training, trouble shooting, and patient information video presentations as well as novel robotic equipment are some of the other important topics that will be discussed with the audience by highly skilled and experienced speakers.

The aim of the ERUS-EAUN Robotic Urology Nursing Meeting is to become thè educational platform for OR nurses and RNFAs working with robot-assisted urology surgery. The programme will include the latest research in our field of expertise and also look ahead at what the future will bring. The meeting will offer theoretical in-depth knowledge and and will discuss many practical aspects that are important for nurses working in robot-assisted urology surgery.

On the two other days of the ERUS programme nurse delegates that register for the full meeting will attend the lectures and live surgery sessions of the regular ERUS programme, to return home completely updated on the latest developments in the field.

On the first day the English version of the nurses' programme will take place, on the second day the German nurses’ programme.

Photo credit: www.franciscanhealth.org (https://creativecommons.org/licenses/ by-sa/4.0/deed.en)

• Increase awareness of the importance of having the right competences in the operating room • Define the role of the operating room nurse in robotic surgery • Enable the participant to take part in discussions how to handle minor and major complications in robotic assisted urology surgery • Address the importance of a skilled robotic team and team efficiency in the operating room, including crucial knowledge on how robotic surgery affects the patient • Inspire both OR Nurses and RNFA´s in their daily work in the operating room to achieve a higher satisfaction and joy in their field of expertise Don’t miss it!

Aims and objectives • Increase the understanding of the bedside role of the nurse in the operating room • Offer extensive in-depth knowledge of the most common urologic procedures such as prostate cancer, kidney cancer and bladder cancer as performed today • Deepen the knowledge of the patient´s pathway from diagnosis to surgery

Register before 4 August 2020 and benefit from the early fee!

Register now at www.erus20.org

More information: https://erus.uroweb.org/scientific-programme/erus-eaun/ 36

European Urology Today

March/May 2020

Profile for European Association of Urology (EAU)

European Urology Today Vol. 32 No.2 - March/May 2020  

European Urology Today is the official newsletter of the European Association of Urology.

European Urology Today Vol. 32 No.2 - March/May 2020  

European Urology Today is the official newsletter of the European Association of Urology.

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