The Artificial Urinary Sphincter Clinical Outcomes Trial: Primary Results

PURPOSE: The artificial urinary sphincter (AUS) endures as the standard-of-care treatment for mild-to-severe male stress urinary incontinence. Prior studies report outcomes from predominantly single-center retrospective series. In this study, we present data from a multi-institutional analysis of AUS clinical outcomes to assess efficacy, safety, and quality of life (QOL) to standardize result reporting. MATERIALS AND METHODS: Artificial Urinary Sphincter Clinical Outcomes is a single-arm, prospective, multicenter study designed to evaluate the American Medical Systems 800 in men with primary stress urinary incontinence (NCT04088331). One hundred fifteen participants were implanted at 17 sites. The primary end point was ≥ 50% improvement in 24-hour pad weight 12 months post device activation. Secondary end points including pad use, urinary incontinence events per day, QOL, and device satisfaction were measured between 3 and 12 months post device activation and compared with baseline. RESULTS: < .001) and 60% (61/101) reported zero pad use. Participants also reported substantial improvement in QOL scores and incontinence events per day post device activation. Seventeen participants (15%) had serious adverse events, 10 (8.7%) in which the events were device related. Nine participants (7.8%) had revisions: mechanical malfunction (3), erosion (2), lack of efficacy (1), other (3), and zero due to infection. CONCLUSIONS: In this prospective trial, the AUS allowed most men to achieve total continence with a serious adverse event rate less than 15%. Participants experienced significant continence recovery with transformational improvement in patient-reported outcomes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04088331.