Two experts took up that debate during Sunday morning’s Prime Time plenary session in a 20-minute presentation moderated by Ranjith Ramasamy, MD, assistant professor and Director of Reproductive Urology at the University of Miami.
“Current ED treatment options include PDE5 inhibitors (PDE5-i), vacuum erection devices, intracevernosal injections, intraurethral suppositories and penile implants,” said Dr. Ramasamy, setting the stage for the debate. “These treatments attempt to improve erectile function without treating the underlying pathophysiology of ED, leaving us with the question as to whether we can actually heal the penis.”
Shockwave therapy for treating erectile dysfunction, he noted, is quite different from extracorporeal shockwave lithotripsy (ESWL®) used to treat kidney stones.
“ESWL has a smaller focal volume and the energy is concentrated, as opposed to ED, where the shockwaves are radial, the focal volume is larger and the energy is spread over a greater area,” Dr. Ramasamy explained. “In fact, the energy is about 10 percent of what we use for ESWL for kidney stones.”
The case in favor of shockwave therapy for ED was presented by Irwin Goldstein, MD, Director of Sexual Medicine at Alvarado Hospital, clinical professor of Surgery at the University of California, San Diego, Director of San Diego Sexual Medicine and Editor-in-Chief of Sexual Medicine Reviews.
“So, why are we looking at shockwave therapy when we already have everything we need to treat erectile dysfunction?” he asked. “We have pills now that are amazing, although they are not for everyone. They are contraindicated, for example, in people who can’t walk up three flights of stairs. Additionally, the pills don’t work in about 30 percent of people, and half of the people discontinue therapy. So, the search for additional therapies is ongoing.”
While traditional ED therapies are effective at treating the symptoms of ED, they do not change the underlying pathophysiology of the condition.
“Through shockwave therapy, we’re introducing a new paradigm of disease modification to the treatment of ED,” Dr. Goldstein said. “You can take a pill, but you wake up the next day with the same erectile tissue and the same problem. If you undergo shockwave therapy, what we hope it will do is change the health of the tissue. Injections, pills or implants don’t really address pathology reversal, but low intensity shockwave will.”
Although shockwave therapy for treating ED has not received approval from the U.S. Food and Drug Administration, Dr. Goldstein said he is involved in a clinical trial that he hopes will change that.
“I think we have a lot of good clinical data to support shockwave therapy in humans,” he said. “We are now involved in a randomized double-blind, placebo controlled, open label extension of an earlier pilot study we did. We believe this is a revolutionary therapy and we hope that the data we present in the future will get us across the finish line and get this therapy approved.”
Arguing against the use of shockwave therapy for ED, Tom Lue, MD, professor and Vice Chair of Urology at the University of California, San Francisco, said he believes there are still too many unanswered questions regarding the optimal energy range, frequency of treatment and long-term effects that need to be answered before abandoning traditional treatment strategies.
“In shockwave therapy, the energy level is very important. At a certain level, you may have a beneficial effect. But if you gradually go higher, it’s less and less effective,” he said. “In fact, a 2008 study in animals showed that at higher levels, animals actually become impotent and it causes fibrosis. So, there’s some concern that, unless you know the ideal energy level and unless you can calculate the biologic effect, it’s not going to work and it may actually harm the patient.”