Clinical trial update on shockwave therapy and future of erectile function restoration.

Our interim analysis of a phase II clinical trial on low-intensity extracorporeal shockwave therapy (Li-ESWT) for men with erectile dysfunction (ED) has demonstrated it is safe with no reported adverse outcomes. Interim analysis has demonstrated Sexual Encounter Profile 3 (ability to maintain erection till completion) was achieved in 60% of men prior to Li-ESWT, which increased to 90% after treatment. Nevertheless, limitations of our clinical trial include the lack of a sham arm and our inability to exclude men with psychogenic ED. We have begun recruitment of our phase III clinical trial that will allow assessment of treatment efficacy against a sham control arm. There exists substantial interest in the use of restorative therapies (i.e., Li-ESWT, stem cells, and platelet rich plasma) for men with ED with the potential to combine therapies to potentially lead to an augmented response.