A novel, on-demand therapy for premature ejaculation using a miniature trans-perineal electrical stimulator: a randomized-controlled trial

Abstract

<h3>Objectives</h3> To assess the feasibility, safety, and efficacy of a miniaturized on-demand perineal Transcutaneous Electrical Stimulation (TES) Using the vPatch device, for the treatment of premature ejaculation (PE). <h3>Methods</h3> We designed a bi-center, international, prospective, randomized, double-blind, sham-controlled, clinical study. A total of 59 lifelong PE patients were included. After the screening visit (Visit 1), patients measured their intravaginal ejaculatory latency time (IELT) for a 2-week run-in period and complete the Premature Ejaculation Profile (PEP) questionnaire. At Visit 2, eligible patients tried vPatch to determine the individualized sensory and motor activation thresholds. Patients were randomized into active and sham arms in a 2:1 ratio. At Visit 3, the IELT values and PEP outcomes were recorded again. Clinical Global Impression of Change (CGIC) scores were noted. <h3>Results</h3> Of the patients, 51 completed the study, 34 in the active and 17 in the sham arm. In the active arm the Baseline Geometric Mean IELT (BGMI) was 67 seconds (s) and significantly increased by 56s (standard error (SE) 9s) to 123s (p<.0001). However, in the sham arm the BGMI was 63s and increased insignificantly by 17s (SE 12s) to 80s (p=0.1653). The increase in IELT from base line was 3.22-fold greater in favor of the active arm (p=0.0047). In the active arm 91% (31/34) of the subjects significantly improved their IELT due to treatment compared to baseline. The mean geometric time-fold in IELT, in those positive responders was 2.04 (CI 95% 1.68-2.4). According to the CGIC, patients in the active group were significantly more satisfied with the treatment (74% vs. 41%, p=0.0274). The subjects in the active arm reported significant improvement in all 4 PEP parameters (P<0.05). <h3>Conclusions</h3> IELT values and patient-reported outcome measures can be improved with TES using vPatch. This treatment may become an on-demand, noninvasive, and drug-free therapeutic option for lifelong PE. <h3>Conflicts of Interest</h3> This study was sponsored by Virility Medical Ltd