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.
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.
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.
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.
The Journal of urology. 2025 Oct 03 [Epub ahead of print]
Melissa R Kaufman, Hadley M Wood, Ryan Terlecki, Daniel Moon, Jeremy Myers, Alex J Vanni, LeRoy Jones, Joshua A Broghammer, Gerard Henry, Benjamin N Breyer, Bradley Erickson, Arthur L Burnett, Niels V Johnsen, Lewis Wen Loong Chan, Brian J Flynn, Rose Khavari, Thomas G Smith, Sean Elliott, Erin L Chaussee, Kaitlyn Rainbow, Andrew C Peterson
Vanderbilt University Medical Center, Nashville, TN; Associate Editor, The Journal of Urology., Glickman Urological Institute, Cleveland, OH., Atrium Health Wake Forest Baptist, Winston-Salem, NC., University of Melbourne, Royal Melbourne Clinical School, Melbourne, VIC, Australia., University of Utah, Salt Lake City, UT., Lahey Hospital and Medical Center, Burlington, MA., Urology San Antonio, San Antonio, TX., University of Kansas Medical Center, Lawrence, KS., Willis-Knighton Bossier Medical Center, Bossier City, LA., University of California San Francisco San Francisco, CA., University of Iowa Hospitals and Clinics Iowa City, IA; North Central Section Representative, The Journal of Urology., Johns Hopkins Medicine Institutions Baltimore, MD., Vanderbilt University Medical Center Nashville, TN; Review Board Member, The Journal of Urology., Concord Repatriation General Hospital Sydney, NSW, Australia., University of Colorado, Anschutz Medical Campus Aurora, CO., Houston Methodist Hospital and Weill Cornell Medicine Houston, TX; Assistant Editor, The Journal of Urology., Anderson Cancer Center Houston, TX., University of Minnesota Minneapolis, MN; Urological Survey Editor, The Journal of Urology., Boston Scientific Minnetonka, MN., Duke University Medical Center Durham, NC; Southeastern Section Representative, The Journal of Urology.