PS-06-007 Low Intensity Extracorporeal Shock Wave Therapy (Li-ESWT) for Erectile Dysfunction: Is it Worthy to Repeat Treatment?

Li-ESWT has been shown to be efficacious and safe for the treatment of erectile dysfunction (ED). Although the possibility of repeated Li-ESWT is often mentioned, the safety and efficacy of repeat Li-ESWT have not been fully explored. The purpose of the present study is to examine the impact of repeating Li-ESWT sessions in patients with vasculogenic ED, who had received Li-ESWT 6 months prior. This is a randomized, 2 parallel arms, 2 phase study, approved by the IRB. The study sample included patients with mild-severe ED, responders to PDE5 inhibitors. At Phase I, all patients received randomly either 6 (Group A) or 12 sessions (Group B) of Li-ESWT, and followed up for 6 months. Completers of phase I were eligible to enter phase II, receiving 6 more Li-ESWT sessions. All patients were treated using the ARIES® device (Dornier MedTech, Germany). Proportion of patients achieving the minimal clinically important difference (MCID) in the EF domain of the IIEF (IIEF-ED) and change in Sexual Encounter Profile question 3 (SEP3) from baseline to the end of phase I and II, were the primary endpoints of the study. Triplex ultrasonography was conducted by the same investigator, at baseline and at 3 months follow-up visit in both phase I and II. This abstract describes the interim analysis at 3 months follow-up of phase II. Differences between Group A and B were evaluated using Fisher’s exact test (MCID) and t-test for independent samples (SEP3).