Urologist Koushik Shaw, MD, of Austin Urology Institute in Austin, TX, said patient demand and the concern that patients are going to non-urologic providers for unproven stem cell treatments is putting pressure on urologists like him to look into offering the therapies. While Dr. Shaw said he offers shock wave treatment for erectile dysfunction but no stem cell treatments, he is considering offering PRP if supported by clinical studies.
“I think it all has to be done with informed consent, with eyes wide open. Make sure the patient understands it’s not FDA approved, studies are limited, and the expectation should be limited,” Dr. Shaw said. “In our city, we have a plastic surgeon and ER physicians who offer shock wave therapy for erectile dysfunction. I see med spas doing it. The whole men’s health movement is ours to lose.”
Stem cell therapies are a different matter, according to Leigh Turner, PhD, associate professor at the Center for Bioethics, School of Public Health and College of Pharmacy at University of Minnesota, Minneapolis. Urologists and others who are concerned with being compliant and operating within evidence-based medical practice should consider steering clear of administering stem cell products, unless it’s in a research setting, according to Dr. Turner.
“And it’s not clear whether down the road these are going to be evidence-based therapies,” said Dr. Turner. A 2016 paper that he co-authored found more than 50 of the 351 U.S. businesses engaged in direct-to-consumer marketing of stem cell interventions offered urologic services. Urologic conditions ranked seventh most common among 29 marketed conditions (Cell Stem Cell 2016; 19:154-7).
Dr. Turner called this risky terrain for urologists.
“They run the risk of violating federal law. If it’s a licensed medical practitioner, people could get in trouble with their state medical boards or the Federal Trade Commission,” Dr. Turner said.
For now, there are less risky and promising stem cell-like approaches to conditions such as erectile dysfunction. One is not to inject stem cells but rather attract stem cells to the penis with low-intensity shock wave therapy, according to Dr. Stahl.
“There’s a fairly large body of basic scientific literature indicating that low-intensity shock wave therapy works by attracting stem cells to the penis and by promoting neo-angiogenesis,” Dr. Stahl said.
Providing the therapy involves using an FDA-cleared device with “genuine” shock waves, according to Irwin Goldstein, MD, a urologist who practices sexual medicine in San Diego and and is director of the nonprofit Institute for Sexual Medicine (SexualMed.org).
“There are a lot of imitation non-shock wave acoustic sound waves that are being scammed and sold to patients who are desperate,” said Dr. Goldstein, who uses a device known as the UroGold 100. “Real shock wave therapy has been shown to activate endogenous stem cells. This specific device is FDA cleared now in the U.S. for increasing blood flow, connective tissue activation, and amelioration of pain, and the FDA has classified this device a non-significant risk (NSR) to humans.”
He said he has recruited patients for a prospective sham-controlled trial he will conduct looking at shock wave therapy with the UroGold 100 device for erectile dysfunction.
Pursuing evidence-based research on stem cell and other therapies for male sexual function is needed, according to Dr. Goldstein, who also offers PRP for erectile dysfunction.
“The construct of erectile dysfunction management by symptomatic treatment... is what we’ve mostly ever had,” he said. “But now with shock wave therapy, PRP, and one day maybe stem cells, the idea is having a disease modification strategy.
“It is the first time in erectile dysfunction history that we might change a primary underlying pathology and make the situation more responsive to symptomatic treatment or to where the person doesn’t even need symptomatic treatment.”
Dr. Turner filed an expert opinion report in a lawsuit filed against The Lung Institute, which markets purported stem cell treatments for lung diseases. Dr. Goldstein’s practice is a site for a trial sponsored by Tissue Genesis that uses stem cells for erectile dysfunction.