LBA02-11 NOVEL ON-DEMAND TREATMENT FOR LIFELONG PREMATURE EJACULATION USING TRANSCUTANEOUS PERINEAL MINI-PATCH STIMULATOR

Abstract

You have accessJournal of UrologyCME1 May 2022LBA02-11 NOVEL ON-DEMAND TREATMENT FOR LIFELONG PREMATURE EJACULATION USING TRANSCUTANEOUS PERINEAL MINI-PATCH STIMULATOR Ariki Shechter, Nicola Mondaini, Ege Can Serefoglu, Tal Gollan, Boaz Appel, and Ilan Gruenwald Ariki ShechterAriki Shechter More articles by this author , Nicola MondainiNicola Mondaini More articles by this author , Ege Can SerefogluEge Can Serefoglu More articles by this author , Tal GollanTal Gollan More articles by this author , Boaz AppelBoaz Appel More articles by this author , and Ilan GruenwaldIlan Gruenwald More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002670.11AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Background: Premature Ejaculation (PE) is a prevalent sexual dysfunction in men. Available treatments demonstrate limited efficacy and low treatment adherence. Objectives: To assess feasibility, safety, and efficacy of the Mini-patch, an on-demand transcutaneous perineal electrical stimulator, for the treating of PE. METHODS: Design, Setting, and Participants: Bi-center, international, prospective, randomized, double-blind, two-arm, sham-controlled, clinical study. After screening, intravaginal ejaculatory latency time (IELT) of candidates was measured. Eligibility was based on IELT values and medical/sexual history. Patients were randomized to Active and Sham device groups in a 2:1 ratio. Device safety profile was determined by incidence of treatment-emergent adverse events comparison. Outcome Measurements and Statistical Analysis: Clinical Global Impression of Change (CGIC) scores, Premature Ejaculation Profile (PEP) questionnaire outcomes, and Mini-patch safety profile. Statistical power was calculated. Primary endpoints assessed device efficacy by mean fold change in geometric mean IELT (Mini-patch vs. sham treatment compared to baseline values). Adjusted mean difference for treatments, adjusted treatment effects (Mini-patch – sham), 95% confidence intervals (CI), and 2-sided P values were obtained. RESULTS: Of 59 patients randomized, 51 completed the study: 34 in the Active and 17 in the Sham arm. Baseline geometric mean IELT was 67 seconds and significantly increased to 123 seconds (p<0.0001) in the Active group, compared to 63 seconds increasing insignificantly to 81 seconds (p=0.1653) in the Sham group. The IELT significantly increased by 3.22-fold in the Active as compared to the Sham group (p=0.0047). Overall Geometric Mean Time Fold increases of IELT in the Active compared to the Sham group were 1.7 (95% CI 1.5-2.1) vs. 1.2 (95% CI 1.0-1.6), respectively. No serious adverse events were reported. CONCLUSIONS: Mini-patch has the potential to become a leading on-demand, noninvasive, and drug-free treatments for PE. Source of Funding: Virility Medical Ltd; Hod-hasharon, Israel © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e1045 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Ariki Shechter More articles by this author Nicola Mondaini More articles by this author Ege Can Serefoglu More articles by this author Tal Gollan More articles by this author Boaz Appel More articles by this author Ilan Gruenwald More articles by this author Expand All Advertisement PDF DownloadLoading ...