Observational studyThe Journal of urology2026
The Artificial Urinary Sphincter Clinical Outcomes Trial: Primary Results.
Observational study in The Journal of urology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04088331 (Artificial Urinary Sphincter Clinical Outcomes), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Artificial Urinary Sphincter Clinical Outcomes
Who cites it
5 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Acupuncture combined with biofeedback electrical stimulation for female stress urinary incontinence: a systematic review and meta-analysis.Frontiers in medicine · 2026Pooled it
- One-Year Functional Satisfaction and Quality of Life Outcomes of Patients With a History of Radiotherapy With Artificial Urinary Sphincters.Neurourology and urodynamics · 2026Article
- An Unexpected Cause of De Novo Urge Incontinence Following Artificial Urinary Sphincter Placement: A Case Report.Journal of clinical medicine · 2026Article
- Modifications of Anti-Incontinence Procedures for Radiated Patients: A Narrative Review.Current urology reports · 2026Review
- AdVance™ XP male sling implantation for stress urinary incontinence after orthotopic ileal neobladder reconstruction.Archive of clinical cases · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
21 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe 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
methodsArtificial 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.
resultsAt 12 months, 94% (91/97) participants experienced ≥ 50% pad weight reduction (
conclusionsIn 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 registrationClinicalTrials.gov Identifier: NCT04088331.
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Registered trials
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