NEW prospective data have reinforced the role of the artificial urinary sphincter (AUS) as the standard-of-care treatment for male stress urinary incontinence, demonstrating high rates of continence recovery and meaningful improvements in quality of life with an acceptable safety profile.
Artificial Urinary Sphincter Trial Design and Objectives
The Artificial Urinary Sphincter Clinical Outcomes Trial represents one of the largest multicentre prospective evaluations of AUS outcomes to date. The study enrolled 115 men with primary stress urinary incontinence across 17 centres, addressing limitations of prior evidence that was largely derived from single-centre retrospective series.
Participants received implantation of the American Medical Systems 800 AUS and were followed for up to 12 months after device activation. The primary endpoint was a ≥50% reduction in 24-hour pad weight at 12 months, an objective measure of urinary leakage. Secondary endpoints included pad use, daily incontinence episodes, patient-reported quality of life (QOL), and device satisfaction.
Artificial Urinary Sphincter: Key Trial Results
At 12 months, 94% of evaluable participants achieved the primary endpoint, with a statistically significant reduction in pad weight compared with baseline. Furthermore, 60% of men reported complete continence, requiring no pads. Substantial improvements were also observed in daily incontinence episodes and validated QOL measures, indicating broad functional and psychosocial benefits following AUS implantation.
Safety outcomes were consistent with established expectations for implantable urological devices. Serious adverse events occurred in 15% of participants, with 8.7% deemed device related. Device revision was required in 7.8% of cases, most commonly due to mechanical malfunction or erosion. Notably, no revisions were required due to infection, an important consideration in long-term implant success.
The authors conclude that this prospective, multicentre analysis confirms the AUS as a highly effective intervention for men with mild-to-severe stress urinary incontinence. The trial provides robust, standardised outcome data demonstrating that most patients can achieve substantial, and often complete, continence with significant improvements in patient-reported outcomes.
These findings strengthen the evidence base supporting AUS use and establish a benchmark for future reporting of clinical outcomes in male urinary incontinence management.
Reference
Kaufman M et al. The Artificial Urinary Sphincter Clinical Outcomes Trial: Primary Results. J Urol. 2026. 215(2):194–202.
