Systematic review evaluates device longevity and complications in male patients, suggesting significant concerns remain.
Introduction Artificial urinary sphincter (AUS) implantation surgery is a key solution in the management of moderate and severe urinary incontinence. Objective Still, reported AUS outcomes and complications differ widely across published papers, making a systematic review and meta-analysis essential to establish reliable pooled rates from high-volume cohorts and improve clinical decision-making. Methods We performed a systematic review and a series of meta-analyses for AUS device survival, mechanical failures, and complication rates, considering only studies with at least 100 patients (biological men only) and a minimum 1-year follow-up. Results Patients with AUS may experience a broad range of complications, spanning general implant-related issues (for instance, infection or hematoma) and AUS-specific problems such as cuff erosion or fluid loss from the system. Specifically, a pooled prevalence of infection was 4.5% (95% confidence intervals CI 2.3-5.2%). Examples of mechanical malfunction included issues with each of the AUS components (urethral cuff, pressure regulating balloon, and other parts), and a pooled estimated rate of mechanical failure was calculated as 12.3% (CI 10.2-16.4). Among non-infectious complications, the most commonly reported problems were erosion (pooled estimated prevalence 6.8%, CI 4.0-9.2%), urethral atrophy (8.1%, CI 6.2-9.9%), and hematoma (2.0%, CI 0.8-3.5%). In general, long-term AUS device survival declined steadily; pooled estimated survival rates amounted to 72.0% (CI 68.2-75.4%) at 5 years post-implantation and to 56.7% (CI 52.9-58.1%) at 10 years. Conclusions Although the artificial urinary sphincter is highly effective for severe incontinence, postoperative complications and device failures remain clinically relevant. Future studies should focus on long-term performance, device innovation, and evidence-based strategies to reduce reoperation rates. Disclosure No
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Sforza et al. (2026) studied this question.
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