Abstract
You have accessJournal of UrologyCME1 Apr 2023MP79-20 LOW-INTENSITY SHOCKWAVE THERAPY: SUSTAINED IMPROVEMENT IN THE TREATMENT OF ERECTILE DYSFUNCTION Jeunice Owens-Walton, Emmett Kennady, Christopher Ballantyne, Darren Bryk, Marwan Ali, Sarah Ratcliffe, Indika Mallawaarachchi, Bahrom Ostad, Hamza Beano, Matthew Clements, Mikel Gray, David Rapp, Nicolas Ortiz, and Ryan Smith Jeunice Owens-WaltonJeunice Owens-Walton More articles by this author , Emmett KennadyEmmett Kennady More articles by this author , Christopher BallantyneChristopher Ballantyne More articles by this author , Darren BrykDarren Bryk More articles by this author , Marwan AliMarwan Ali More articles by this author , Sarah RatcliffeSarah Ratcliffe More articles by this author , Indika MallawaarachchiIndika Mallawaarachchi More articles by this author , Bahrom OstadBahrom Ostad More articles by this author , Hamza BeanoHamza Beano More articles by this author , Matthew ClementsMatthew Clements More articles by this author , Mikel GrayMikel Gray More articles by this author , David RappDavid Rapp More articles by this author , Nicolas OrtizNicolas Ortiz More articles by this author , and Ryan SmithRyan Smith More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003356.20AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Restorative therapies for erectile dysfunction (ED), such as Low-intensity Shockwave Lithotripsy (LiSWT) have generated substantial interest. Despite growing popularity, there are mixed data as to the efficacy of LiSWT and unanswered questions regarding the appropriate patient population for use. This study is a 2-arm stratified, randomized controlled clinical trial to determine whether LiSWT is superior to a sham control for treatment of ED. METHODS: A total of 32 patients with mild to moderate ED (SHIM ≥8 and ≤21) were randomized to LiSWT or sham. In this single-blinded study, patients on the sham arm were allowed to cross over at one month of treatment. Patients underwent twice weekly LiSWT treatments for 3 weeks (6 total) with the Storz® Duolith™ device each delivering 3000 shockwaves at 0.1 mJ/mm2 to the distal penis, base of penis, and crura. Primary outcomes included absolute and relative changes in SHIM score and EHS from baseline to 1, 3, and 6 months post-treatment. Changes in SHIM scores were evaluated with Student’s t-test, while changes in EHS were evaluated using Wilcoxon rank-sum test. RESULTS: Of the subjects randomized to sham, all elected to cross over to LiSWT at 1 month. At 1, 3, and 6 months post-treatment, the mean absolute changes in SHIM scores were 4.2, 4.7, and 5.4, respectively, in the LiSWT group compared to -0.7 in the sham group at 1 month (p<0.001) (Figure 1A). The percentage improvement in SHIM scores were 51.7%, 54.6%, and 60% at 1, 3, and 6 months post-treatment, respectively (p<0.001). EHS improved in the LiSWT group with median absolute improvements of 0.6, 0.9, and 1.0 (p<0.001) (Figure 1B) and percentage improvements 41.1%, 61.1%, and 68.8% over the same time course (p<0.001). The mean EHS improved from baseline of 2 to 2.9 over the treatment course. No adverse outcomes were reported. CONCLUSIONS: Our analysis demonstrates an absolute and durable improvement in SHIM scores and EHS in men undergoing LiSWT for ED at 1, 3, and 6 months post-treatment compared to sham. SHIM score improvements met criteria for previously established minimal clinically significant differences in the erectile function domain of the SHIM (≥4). While limited by population size, the current study is promising for minimally invasive management of ED symptoms. Source of Funding: No funding to disclose © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1149 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Jeunice Owens-Walton More articles by this author Emmett Kennady More articles by this author Christopher Ballantyne More articles by this author Darren Bryk More articles by this author Marwan Ali More articles by this author Sarah Ratcliffe More articles by this author Indika Mallawaarachchi More articles by this author Bahrom Ostad More articles by this author Hamza Beano More articles by this author Matthew Clements More articles by this author Mikel Gray More articles by this author David Rapp More articles by this author Nicolas Ortiz More articles by this author Ryan Smith More articles by this author Expand All Advertisement PDF downloadLoading ...
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