Journal article
The Artificial Urinary Sphincter Clinical Outcomes Trial: Primary Results
The Journal of urology, Vol.215(2), pp.194-202
02/2026
DOI: 10.1097/JU.0000000000004796
PMCID: PMC12794701
PMID: 41042705
Abstract
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.
Details
- Title: Subtitle
- The Artificial Urinary Sphincter Clinical Outcomes Trial: Primary Results
- Creators
- Melissa R Kaufman - Vanderbilt University Medical CenterHadley M Wood - Glickman Urological Institute, Cleveland, OHRyan Terlecki - Atrium Health Wake Forest BaptistDaniel Moon - The Royal Melbourne HospitalJeremy Myers - University of UtahAlex J Vanni - Lahey Medical CenterLeRoy Jones - Urology San AntonioJoshua A Broghammer - University of Kansas Medical CenterGerard Henry - Willis-Knighton Bossier Medical Center, Bossier City, LABenjamin N Breyer - University of California, San FranciscoBradley Erickson - University of IowaArthur L Burnett - Johns Hopkins UniversityNiels V Johnsen - Vanderbilt University Medical CenterLewis Wen Loong Chan - Concord Repatriation General HospitalBrian J Flynn - University of Colorado Anschutz Medical CampusRose Khavari - Cornell UniversityThomas G Smith III - The University of Texas MD Anderson Cancer CenterSean Elliott - University of MinnesotaErin L Chaussee - Boston Scientific (United States)Kaitlyn Rainbow - Boston Scientific (United States)Andrew C Peterson - Duke Medical Center
- Resource Type
- Journal article
- Publication Details
- The Journal of urology, Vol.215(2), pp.194-202
- DOI
- 10.1097/JU.0000000000004796
- PMID
- 41042705
- PMCID
- PMC12794701
- NLM abbreviation
- J Urol
- ISSN
- 1527-3792
- eISSN
- 1527-3792
- Publisher
- LIPPINCOTT WILLIAMS & WILKINS; PHILADELPHIA
- Grant note
- Boston Scientific
This study was supported by Boston Scientific.
- Language
- English
- Electronic publication date
- 10/03/2025
- Date published
- 02/2026
- Academic Unit
- Urology
- Record Identifier
- 9984969110502771
Metrics
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