Peyronie’s disease results underwhelm
Dr. Hatzichristodoulou, who conducted the first placebo-controlled prospective study on shock wave therapy in patients with Peyronie’s disease while he was a medical student about 17 years ago, says there are three placebo-controlled studies available worldwide on this treatment modality and all show that shock wave treatment in Peyronie’s disease is effective to treat penile pain, but it does not improve nor correct penile curvature.
“We know that 90% of patients with Peyronie’s disease will be pain free during the natural disease course. The question arises whether we should treat Peyronie’s disease with extracorporeal shock wave therapy because we know that pain will resolve over time without treatment,” Dr. Hatzichristodoulou said. “The most important and predominant symptom of patients with Peyronie’s disease is penile curvature. And this is the most important symptom because it can lead to the inability of the patient to perform sexual intercourse. And we cannot treat penile curvature with shock wave therapy.”
These data do not stop companies from promoting shock wave devices for treatment for Peyronie’s disease. One manufacturer’s website claims that most men treated for Peyronie’s disease “are able to return to optimal sexual performance after therapy.”
Spotlight on controversies
Tobias Kohler, MD, MPH, professor of urology at Mayo Clinic, Rochester, MN, made a YouTube video about erectile dysfunction treatment scams. On his “unproven” list is the use of shock wave therapy.
“There are two types of shock wave machines,” Dr. Kohler explained. “There’s the SwissWave, which is a class 1 medical device that’s offered throughout the country by chiropractors and the like with claims that it improves erectile dysfunction. Because it’s a class 1 medical device, they can offer this to patients and administer it without a worry from the FDA.
“The question is, why is it a class 1 medical device? Because it doesn’t do anything. It delivers a shock which is very shallow and of insufficient energy to do anything to any kind of scar tissue in the penis. There is zero point zero medical literature supporting the use of this type of shock wave therapy for problems with erection,” Dr. Kohler said.
Another company involved with shock wave therapy for erectile dysfunction is GAINSWave. According to a spokesperson for the company, GAINSWave is a marketing organization that educates consumers and raises public awareness for low-intensity shock wave therapy for erectile dysfunction. According to Dr. Kohler, men are flocking to clinics that offer treatment with the class 1 medical devices, spending thousands of dollars without real evidence that they work.
The class 2 shock wave therapy devices are FDA regulated and cannot be used outside a clinical trial, Dr. Kohler explained.
“That’s the difference. Those are the real machines that actually deliver shocks,” Dr. Kohler said. “There are some good researchers working on studies with those devices. Is there a role for shock wave therapy? Maybe. We need to do more trials, and until more work is done, men should not spend their money on it.”
For now, a lot of urologists are sitting on the sidelines.
Allen D. Seftel, MD, chief of urology at Cooper University Hospital, Camden, NJ, does not offer shock wave therapy for ED or Peyronie’s disease because it’s considered experimental by the AUA guideline panel and his patient population wouldn’t be able to afford the treatment without coverage, he said.
“Nonetheless, it seems that select physicians are offering it for treatment and that patients are paying out of pocket,” Dr. Seftel said. “The good news is that several short-term, suboptimally designed studies have shown promise, which is encouraging. The really good news is that it appears that there is no negative impact reported in these studies for the shock wave for ED treatment. Thus, a large, well-done study may actually provide the data needed to make an informed decision."