MP79-11 A SHAM-CONTROLLED RANDOMIZED TRIAL OF LOW INTENSITY SHOCKWAVE THERAPY FOR ERECTILE DYSFUNCTION

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You have accessJournal of UrologyCME1 Apr 2023MP79-11 A SHAM-CONTROLLED RANDOMIZED TRIAL OF LOW INTENSITY SHOCKWAVE THERAPY FOR ERECTILE DYSFUNCTION Irwin Goldstein, Sue W. Goldstein, and Noel N. Kim Irwin GoldsteinIrwin Goldstein More articles by this author , Sue W. GoldsteinSue W. Goldstein More articles by this author , and Noel N. KimNoel N. Kim More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003356.11AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: We performed a sham-controlled, randomized prospective trial in men with ED using an electrohydraulic shockwave device FDA cleared for connective tissue activation and improved blood flow. METHODS: This single-blind study was performed in men with ED naïve to acoustic wave and shockwave therapy. Patients were randomized to treatment and assigned to active low intensity shockwave therapy (LiSWT) (4 Hz, 0.12 mJ/mm2) or sham treatment, 2:1. Arm 1 consisted of 3 treatments of 5000 shocks every 3 weeks. Arm 2 consisted of 5000, 3000, and 3000 shocks during weeks 1, 2, and 3, respectively, followed by an identical cycle of treatment 3 weeks later. Doppler ultrasound and grayscale imaging with a 15.4 MHz probe were performed under pharmacologic erection at weeks 20 and 32. Subjects completing sham treatment were unblinded and crossed over to the opposite arm for active treatment. Post-treatment end diastolic velocity (EDV) and peak systolic velocity (PSV) were measured, and visual grading scores were used to assess extent of hypoechoic regions in the corpora cavernosa. Data were analyzed by 2-way repeated measures ANOVA with Geisser-Greenhouse correction. Pairwise comparisons were performed to baseline used Dunnett’s multiple comparison test. Missing data were imputed by “last observation carried forward”. RESULTS: Although powered for 60, recruitment was limited due to COVID and 36 subjects (22 active, 14 sham) were randomized. Sham treatments showed no significant changes in outcome measures. The number of subjects with improved visual grading scores in the proximal region was consistently higher in active LiSWT vs sham (Arm 1=88.9% vs. 11.1%; Arm 2=40.0% vs. 20.0%, respectively) with statistical significance in Arm 1 at weeks 20 (p=0.005) and 32 (p=0.001). Sham subjects rolled over to active LiSWT also had improved grayscale ratings (Arm 1=33.3% vs. 11.1%; Arm 2=40.0% vs. 20.0%). After LiSWT, greater numbers of patients had higher PSV, lower EDV, or no worsening of blood flow parameters relative to baseline. Decrease in EDV was statistically significant in active treatment Arm 2 at Week 32 (p=0.003). Mean IIEF-EF scores were nominally higher in subjects in active treatment who had improved visual grading scores vs those with no improvement. Adverse events were transient. CONCLUSIONS: Flaccid penile LiSWT appears to be safe and efficacious for treating ED based on statistically significant changes from baseline between sham and active treatments in primary outcome measures. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1145 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Irwin Goldstein More articles by this author Sue W. Goldstein More articles by this author Noel N. Kim More articles by this author Expand All Advertisement PDF downloadLoading ...