(360) Low-Intensity Shockwave Therapy (LiSWT) Appears to Show Improvement in Erectile Function at 1 Month Compared to SHAM in Men with Erectile Dysfunction

Abstract

Abstract Introduction Restorative therapies such as Low-intensity Shockwave Lithotripsy (LiSWT) for erectile dysfunction (ED) have generated substantial interest. Despite growing popularity, a paucity of data exists to confirm efficacy in reversing underlying pathophysiologies of ED. Objective We evaluated the efficacy of the Storz® Duolith™ to determine whether active versus sham treatment is superior for treatment of ED. Methods We performed a two-arm stratified, single-blinded, randomized controlled clinical trial. Inclusion/exclusion criteria are listed in table 1. A total of 31 patients were enrolled, with 15 randomized to the sham group and 16 to the treatment group. Patients underwent LiSWT with the Duolith™ device delivered twice weekly for 3 weeks, comprising 3000 shockwaves at 0.1 mJ/mm2 delivered to the distal penis, base of penis, and crura. Outcomes included absolute change in IIEF/SHIM score and change in EHS score. Changes in SHIM scores were compared between the treatment arms using Student’s t-test, while changes in EHS scores were compared using Wilcoxon rank-sum test. Results Demographic and baseline clinical characteristics were similar between arms. At one-month post-treatment, SHIM scores improved by 3.4 points in the LiSWT arm while no improvement was seen in the sham arm (-3.4 vs. 0.7, p=0.014). This corresponded to a 42.1% improvement in the LiSWT arm and a 0.1% decline in the sham arm. No significant differences were observed in EHS change scores between treatment arms. No adverse outcomes were reported. Conclusions The present interim analysis shows improvement in SHIM scores in men undergoing LiSWT for ED. Additional recruitment and follow-up is in ongoing to further demonstrate efficacy and sustainability of LiSWT in the treatment of ED. Disclosure No