The artificial urinary sphincter after a quarter of a century: a critical systematic review of its use in male non-neurogenic incontinence.

Context: The artificial urinary sphincter (AUS) has historically been considered the gold standard for the surgical management of non-neurogenic stress urinary incontinence (SUI) in men. As new surgical alternatives attempt to offer alternatives to treat male SUI, a contemporary assessment of the evidence supporting the use of AUS appears mandatory for clinical decision making.

Objective: To conduct a critical systematic review of long-term outcomes after AUS implantation in male patients with non-neurogenic SUI.

Evidence Acquisition: A literature search was conducted in PubMed/Medline and Embase databases using the keywords urinary incontinence and urinary sphincter, artificial and male, restricted to articles published in Dutch, English, French, and German between 1989 and 2011. Studies were included if they reported outcomes after AUS implantation in patients with non-neurogenic SUI with a minimum follow-up of 2 yr. Studies with heterogeneous populations were included if information about non-neurogenic patients was displayed separately.

Evidence Synthesis: Twelve reports were identified, gathering data about 623 patients. Only three studies were prospective. Continence, evaluated only by patient-reported pad use and various questionnaires, was achieved in 61-100% of cases (no pad or one pad per day). Dry rates (no pad) were only available in seven studies and varied from 4% to 86%. A pooled analysis showed that infection or erosion occurred in 8.5% of cases (3.3-27.8%), mechanical failure in 6.2% of cases (2.0-13.8%), and urethral atrophy in 7.9% (1.9-28.6%). Reoperation rate was 26.0% (14.8-44.8%). Patient satisfaction was evaluated in four studies with four different tools and seems to improve after AUS implantation.

Conclusions: Quality of evidence supporting the use of AUS in non-neurogenic male patients with SUI is low, based on heterogeneous data, low-quality studies, and mostly out-of-date efficacy outcome criteria. AUS outcomes need to be revisited to be compared with new surgical alternatives, all of which should be prospectively evaluated according to current evidence-based medicine standards.