"At 1 month, there was a clinically significant improvement in SHIM scoring in men that did receive the treatment vs the sham arm, which didn't," says Jeunice Owens-Walton, MD.
In this interview, Jeunice Owens-Walton, MD, and Emmett Bard Kennady, MD, highlight findings from their study, “Low-intensity shockwave therapy: sustained improvement in the treatment of erectile dysfunction,”1 which was presented at the 2023 American Urological Association Annual Meeting in Chicago, Illinois. Owens-Walton is a first-year resident at the University of Virginia, and Kennady is an incoming intern at the University of Virginia.
Owens-Walton: Our project is a prospective, single-blinded, sham-controlled trial that aims to determine the efficacy of using low intensity of shockwave therapy to restore the organic function of penile tissue. The shockwave therapy induces micro trauma within the tissue, which then releases angiogenic growth factors. It promotes neovascularization, and ideally, what you're doing is restoring penile hemodynamics and ultimately penile function.
Owens-Walton: In our study, we took 33 men with mild to moderate erectile dysfunction, based on a validated erectile dysfunction scoring system, or the SHIM score of 8 to 21. We did a prospective sham-controlled, single-blinded clinical trial, which gave 1 group of men the low-intensity shockwave therapy, and then the other group of men were the sham arm. They received a similar treatment, but the shockwaves were protected by a cap on the device, which did not allow them to receive the therapy.
Ultimately, at 1 month, there was a clinically significant improvement in SHIM scoring in men that did receive the treatment vs the sham arm, which didn't. At that 1 month, the individuals that were in the sham arm were offered to switch over and then receive the treatment. So, they crossed over to the treatment group. We continued at a 1-, 3-, and 6-month time point. In both groups—the group that received the treatment first and the sham arm who then received the treatment thereafter—had clinically significant improvements in their SHIM score of at least 4 points. [That] is the minimal clinically important number to state that this is something that is significant enough to make a change in their lifestyle or their therapy.
In addition, we looked at the erectile hardness scale, which is a 0 to 4 point scale. It looks at the hardness of an erection. About 68% of the men in the group—who had an EHS score of less than 3—were, after the 3- and 6-month time point, above a 3 for their EHS scores.
Kennady: What that means is before, they were unable to achieve an erection sufficient for penetration, and following treatment, 68% of those men who were unable to achieve erection [previously] were able to achieve an erection sufficient for penetration, which is really a marker of practicality in a lot of ways. This is the effect that the men who want this treatment are looking for.
Owens-Walton: From our limited clinical experience as more junior trainees, I think one of the observations that we generally have is that people are looking for less invasive, non-pharmacological solutions to their health problems, and for this it's erectile dysfunction. Shockwave therapy offers that to people. It's not an injection; it's not a pill, both of which can come with some adverse effects or inability to complete treatment. In our study, there were no adverse effects seen, which is a big positive, because it means that people can take their treatment to completion and are able to sustain the therapy.
Kennady: The take-home message here is that 61% of the people in our study reached the minimally clinically important difference in SHIM score, and 68% of the people who were unable to achieve an erection sufficient for penetration were able to following treatment. This says that shockwave therapy is moving out of this category of being an experimental treatment, and more of a treatment that urologists should probably start taking more seriously around the country.
Owens-Walton: I think it would be interesting to look at our study more longitudinally. Currently, we looked at 1, 3, and 6 months. But what does it look like in a year? What does it look like in 2 years? 5 years, 10 years from now? Do we have sustained erectile function? Or does it require that men come back for multiple treatments?
And equally, what does it look like cost-wise? This is something that may, but more than likely not, be covered by insurance, unfortunately. Does that add to the barrier that this is as a treatment? Or is it something that is more cost efficient than some other treatments that are now on the market, despite its current cost at this time?
1. Owens-Walton J, Kennady E, Ballantyne C, et al. Low-intensity shockwave therapy: sustained improvement in the treatment of erectile dysfunction. Presented at: American Urological Association Annual Meeting, April 28-May 1, Chicago. Abstract MP79-20