The Artificial Urinary Sphincter Clinical Outcomes Trial: Primary Results

Purpose: – The artificial urinary sphincter 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. Herein we present data from a multi-institutional analysis of artificial urinary sphincter outcomes (AUSCO) to assess efficacy, safety, and quality of life to standardize result reporting.Materials and Methods: – AUSCO is a single-arm, prospective, multi-center study designed to evaluate the AMS 800™ in men with primary stress urinary incontinence (NCT04088331). One hundred fifteen participants were implanted at 17 sites. The primary endpoint was > 50% improvement in 24-hour pad weight 12 months post device activation. Secondary endpoints including pad use, urinary incontinence events per day, quality of life and device satisfaction were measured between 3- and 12- months post device activation and compared to baseline.Results: – At 12 months, 94% (91/97) participants experienced >50% pad weight reduction (p<0.001) and 60% (61/101) reported zero pad use. Participants also reported substantial improvement in quality of life 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 artificial urinary sphincter 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.