Three options on the table
Low-intensity shock wave therapy is currently one of three experimental disease modification strategies to help restore erectile tissue health. The other two are stem cell infusion and the use of platelet-rich plasma (PRP).
Dr. Goldstein said his site will begin recruiting in December for a trial looking at use of stem cells for erectile dysfunction. The treatment, which uses mesenchymal stem cells, requires liposuction to obtain needed fat cells and a trip to the operating room for the stem cell infusion. PRP, he said, is widely used in sports medicine and orthopedics. The problem is, the therapy is largely uncontrolled in the U.S.
“It’s the Wild West. But that shouldn’t distract from the fact that PRP is a fabulous material. It should be undergoing FDA trials with a robust placebo arm, but it isn’t,” Dr. Goldstein said.
Enter shock wave therapy
The movement to make shock wave therapy a credible and widespread ED option is well on its way.
In a systematic review and meta-analysis published in 2017, Dr. Ramasamy and colleagues analyzed the use of low-intensity extracorporeal shock wave therapy in seven randomized controlled trials, with a total of 602 patients. They found among men with an average age of 60.7 years and an average follow-up of 19.8 weeks, International Index of Erectile Function score significantly improved an average 6.40 points from baseline in men receiving shock wave treatment, compared to an average 1.65 points in those receiving sham therapy (J Sex Med 2017; 14:27-35).
Devices are being studied in clinical trials, and shock wave therapy to treat ED is already being marketed. Aventura, FL-based Sexual MD Solutions markets the GAINSWave therapy brand to enhance sexual performance and optimize erection quality through a network of more than 100 trained providers. According to the company, certified GAINSWave providers must follow specific protocols and are required to use a medical device that is FDA cleared for other indications, including localized improvement of blood flow.
Bruce Sloane, MD, a urologist in private practice in Philadelphia, whose solo practice focuses on men’s health, offers the GAINSWave procedure and said it has shown good results in treating ED.
“I’ve had some men in their 30s who are diabetic and men in their 80s. Some [responses] are more dramatic than others. But every man has improvement in the quality of their erections,” said Dr. Sloane, who had treated about 50 patients when interviewed by Urology Times. “I have a couple men with severe erectile dysfunction who were only getting erections after penile injection therapy. I treated them with 12 sessions of the GAINSWave therapy, and they now only have to use medication. They’re off the injections.”