The ‘Ugly Side’ of ED Care: Sex Medicine Docs Warn of ‘Restorative’ Therapies

SCOTTSDALE, Ariz. — Amid a lucrative boom in experimental alternative treatments for erectile dysfunction (ED), sexual medicine physicians are reiterating that three forms of “restorative therapy” — shockwave, platelet-rich plasma, and stem cell — aren’t ready for use outside of clinical trials.

“There’s a very ugly side to restorative therapies,” since they’re being offered without enough evidence to support their use, said Trinity Bivalacqua, MD, PhD, of the University of Pennsylvania in Philadelphia, during a presentation at the annual scientific meeting of the Sexual Medicine Society of North America (SMSNA).

“These are simply experimental and should not be conducted unless under research protocols, and we should not be charging our patients,” he said.

He noted that the society published a position statement on restorative therapies earlier this year. The statement, an update of a 2019 paper, said that “restorative therapies should be reserved for clinical trials and not offered in routine clinical practice” until adequate studies have demonstrated efficacy and safety.

Similarly, the latest guidelines on ED treatment from the American Urological Association, from 2018, stated that shockwave and stem cell therapy should be considered investigational, while platelet-rich plasma therapy should be considered experimental.

Low-intensity extracorporeal shockwave therapy for ED is especially popular in the U.S., with clinics offering the treatment nationwide. “It can be provided in a lot of non-medical settings. Med spas, anti-aging clinics, basically anybody that has some kind of medical license — and a shockwave machine and a credit card machine — can offer these treatments,” T. Mike Hsieh, MD, of the University of California San Diego, told MedPage Today.

A Utah clinic managed by a physician assistant, for example, touts the “latest natural shockwave therapy for ED.” In Phoenix, an anti-aging clinic run by an internist offers an “all natural, pain-free, non-invasive” therapy for ED via shockwaves: “This protocol allows the penis to accept more blood, leading to better quality erections … Shockwave therapy is the safest ED treatment available to men.”

In his presentation, Bivalacqua — who co-wrote the recent SMSNA position statement — said high-quality studies into shockwave therapy for ED aren’t yet available. “In order for us to show that this is effective and more than just a placebo effect, we need to use a crossover design where patients who receive a sham treatment then receive the active treatment, and those who receive an active treatment then receive the sham treatment.”

However, the SMSNA statement did note that evidence has suggested that the low-intensity shockwave therapy, “within the parameters of studies performed, is safe.”

According to Hsieh, shockwave therapy can cost $400 to $500 per treatment, with patients receiving as many as nine treatments. “Shockwave is so attractive because it’s non-invasive. It feels like a gentle vibration, and you walk in and out in about 15 minutes with no recovery time and no bruising. You can see why that might be very popular compared to other treatments. It’s probably OK to try it, but people should not buy into the promise.”

In regard to platelet-rich plasma and stem cell treatments, the SMSNA position statement noted that there have only been a small number of studies examining these therapies for ED: “At the moment … the cumulative body of clinical trials for restorative therapies is largely incomplete, and many questions remain unanswered.”