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Low-intensity Shockwave Therapy (LiSWT) Program
The Men’s Health Program in the Department of Urology is in a unique position to offer men with erectile dysfunction a rapidly evolving therapeutic option. Erectile dysfunction is a multi-factorial problem with the common pathways of endothelial cell dysfunction and neurovascular compromise. Those patients affected are frequently identified by their cardiologists, endocrinologists, sleep specialists, and primary care physicians. These providers are particularly attuned to this personal, significant medical problem. Erectile dysfunction affects 30-40 million men in the United States, and is commonly associated with aging, chronic neurovascular disease, and diabetes. It also can be a side effect of treatments for diseases such as prostate cancer.
The concept of shockwave therapy as a medical treatment has been with us for many years. In orthopedics, extracorporeal shock wave therapy has been used for at least 20 years to treat injuries to bones, joints, and ligaments. In urology, it is commonly associated with the treatment of kidney stones known as ESWL or extracorporeal shock wave lithotripsy. ESWL technology uses high-energy shock waves to break up kidney stones and usually requires general anesthesia. With the concept of delivering shock waves as a treatment similar in concept, the applications are very different. Low-intensity shockwave therapy (LiSWT) uses a much lower energy that does not require anesthesia. LiSWT involves the use of a small, handheld probe that delivers low-intensity shockwaves to tissues in the penis. In its most basic terms, the treatment is thought to primarily involve microtrauma that results in neovascularization of the structures within the penis. While there is no standardized treatment, in general the LiSWT is administered in six or more weekly sessions.
BASIC SCIENCE SUPPORTING LISWT IN ERECTILE DYSFUNCTION
Normal erectile function depends on an intact penile neurovascular and corporal body function. Conventional therapy for erectile dysfunction (ED) has relied on oral PDE5 inhibitor medications, vacuum erection devices, intra-cavernous injection therapy, and surgical implantation of penile prosthesis. Early intervention with these methods often offers dependable treatments that bypass the pathophysiology of abnormal function, but does not address the underlying pathophysiology of ED, nor does it allow for achieving natural, spontaneous erections. Ideally, the optimal treatment for ED should include a restorative and regenerative approach to penile functioning. Studies over the past decade have shown that LiSWT offers promising outcome efficacy by addressing the basic causes of neurovascular deficiency. Meta-analysis studies of LiSWT have shown functional improvement in men with vasculogenic ED. From extensive animal studies, the salutary effects of LiSWT have rested on multiple mechanisms of action. Its micro-vascular effect is initiated by the creation of endothelial microtrauma with shear stress activating endothelial nitric oxide synthase and the nitric oxide/cGMP
pathway, promoting neo-angiogenesis and improving the microcirculation in corporal tissue. The putative effects on the corpus cavernosal tissue are increased smooth muscle/collagen ratio and decreased lipid formation in erectile vascular tissue. In the interstitial compartment, studies have shown the pro-erectile effects of progenitor/stem cell proliferation and reduction of oxidative stress and inflammation leading to increased smooth muscle cell survival and tissue repair. Additionally, a neurologic advantage has been proposed by demonstrating the effects of LiSWT on Schwann cell activation, nerve repair, regeneration and re-innervation. These multiple effects are summarized in Figure 1. Research is ongoing to determine how well it works long-term, and whether it can replace or be offered along with other proven ED treatments
BUILDING A LOW-INTENSITY SHOCKWAVE THERAPY (LiSWT) RESEARCH PROGRAM
We have started a LiSWT program in the Men’s Health program at Jefferson utilizing the UroGold 100 (SoftWave Tissue Regeneration Technologies, Kennesaw, GA) as shown in Figure 2 (see page 6). This is an electrohydraulic unfocused shockwave delivery system that is FDA-approved for treatment of
plantar fasciitis, lateral epicondylitis, and foot ulcers and is FDA-cleared for improved blood flow, pain amelioration, and connective tissue activation and wound healing. In general, impulses are administered to the penile shaft, hilum, and crura for 6-12 sessions over a period of 6-12 weeks with varying intensity and numbers of impulses. Due to the number of machines available and heterogeneity of protocols, there is no one agreed upon manner to deliver LiSWT impulses, which is one of the challenges of LiSWT at this time. We plan to contribute to the field of knowledge by launching two IRB-approved randomized control trials in early 2023, which will evaluate 1) men with mild to moderate ED of vascular origin, which will be a validation study of a previously described protocol and 2) men
Figure 1. Putative mechanism of action of Li-ESWT for ED. Sokolakis I, Dimitriadis F, Teo P, et al. The Basic Science Behind Low-intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction: A Systematic Scoping Review of Pre-Clinical Studies. J Sex Med. 2019 Feb;16(2):168-194. (Reproduced with permission)
Low-intensity Shockwave Therapy Research Program...Continued from page 5
with mild to moderate ED, who are undergoing radical prostatectomy (Jefferson IRB Approval iRISID-2022-0980).
JEFFERSON’S MEN’S HEALTH PROGRAM
The LiSWT trials are the investigator-initiated studies that will be conducted through the Men’s Health Program based in our Department of Urology Navy Yard Clinic. The project is under the direction of Jefferson’s Men’s Health urologists Drs. Paul Chung, Irvin Hirsch, and Perry Weiner, who is the overall Men’s Health program director. We are excited to bring innovative research and clinical benefits to the community. For additional information on the LiSWT program for the treatment of erectile dysfunction, contact Alana Flowers, Men’s Health navigator at 215-890-1090.
Figure 2. UroGold 100 LiSWT device from SoftWave Tissue Regeneration Technologies, Kennesaw, GA.
Erectile dysfunction is more common than you might think.
Here’s what to know about the causes, risk factors, and treatment options.**
About one-fifth of American men older than age 20 will experience erectile dysfunction (ED)—the persistent inability to maintain or achieve an erection for intercourse—within their lifetime. And 50% of those over the age of 40 have some level of ED.
To know how you can prevent and treat ED, it’s important to first understand what causes it. Here are some of the major risk factors.
HIGH BLOOD PRESSURE
One of the most frequent causes of erectile dysfunction is high blood pressure. “Think about how an erection happens: blood rushes to the penis, creating pressure and making it expand. You need healthy blood vessels to get an erection,” says Paul Chung, MD, FACS, Associate Professor in Sidney Kimmel Medical College and a specialist in reconstructive urology, trauma and prosthetics. “If you have narrow, ruptured or leaky blood vessels, this can be a cause of erectile dysfunction.”
Blood vessels in the penis are small, which means if you are experiencing ED because of hypertension, it could be a predictor of more serious health problems later in life. “If the small blood vessels in the penis are becoming damaged, think about what could happen to the larger blood vessels that lead to the heart or brain—if they become clogged, it can lead to a heart attack or stroke,” says Dr. Chung. Therefore, it’s important to not delay care, even if ED feels like a very personal issue.
PROSTATE CANCER
While prostate cancer is often associated with ED, it does not directly cause it. Prostate cancer treatments result in ED on a temporary or permanent basis. A bundle of nerves that lay on the outside of the prostate can be damaged, whether the prostate is being removed or treated by radiation. Colorectal cancer treatment can also result in ED in some people.
OTHER RISK FACTORS
In general, anything that affects the vascular system can cause ED. This includes coronary artery disease, stroke and being a smoker. Other causes of ED include diabetes, taking anti-anxiety or anti-depression medication, low testosterone, and penile curvature. “Every person is different. My job is to help patients understand why they’re experiencing ED, and educate them on the right treatment options for their wants and needs,” says Dr. Chung.
TREATMENT OPTIONS
When seeking treatment, the initial discussion usually evolves around physical and emotional health. As with many of the prevention strategies listed above, lifestyle changes or changes in the medications that you are using are often the first step in creating a treatment plan. If appropriate, losing weight, stopping smoking, or eliminating drugs or alcohol are common recommendations. Emotional problems could come from relationships, work, stress, depression, or anxiety from past problems with ED (performance anxiety). Sometimes, it is appropriate to refer a man to counseling for a more serious mental health concern.
Next are important considerations such as the physical examination and certain laboratory tests. Occasionally specialized testing may be needed such as ultrasonography (Penile Doppler), pelvic x-ray, or sleep testing.
Occasionally, a correctable factor may be discovered through testing such as low testosterone. Often, there is not a specific correctable factor discovered during the evaluation. While the most common initial ED treatment is an oral medication, there are different approaches and treatment options available. Oral treatment options include phosphodiesterase inhibitors, which promote blood vessel dilation to achieve and maintain a rigid erection. If medication doesn’t work, there are other treatments available, including a vacuum erection device, penile injections, intraurethral suppositories, penile implants, and low-intensity shockwave therapy. Penile implants require a surgical procedure. However, men who receive a penile implant have satisfaction rates of more than 90% in most cases.
Dr. Chung states that it’s important for patients to talk to a urologist about the treatment options. “There are many companies now providing prescriptions online through telehealth appointments, as well as companies offering treatment options that are not FDAapproved or proven effective. Seeing a provider in person means we can help you navigate misconceptions and use diagnostic tools to figure out the best solution for your ED.”
Dr. Chung sums it up by saying: “Our Jefferson Men’s Health Team is hopeful that through proper clinical study and application, our penile low-intensity shock wave therapy (described above) may become a uniformly accepted, minimally invasive treatment option for ED in the future.”
**Adapted from What Causes Erectile Dysfunction and How to Prevent and Treat It by Cassie Drumm. Published on line by Jefferson’s THE HEALTH NEXUS www.jeffersonhealth.org/
