Performance and Safety of the Artificial Urinary Sphincter (AMS 800) for Non-neurogenic Women with Urinary Incontinence Secondary to Intrinsic Sphincter Deficiency: A Systematic Review.

CONTEXT: The use of the artificial urinary sphincter (AUS) for female non-neurogenic severe stress urinary incontinence (SUI) due to sphincter deficiency is either not specifically registered and/or reimbursed in some countries worldwide, as opposed to males, in whom it is considered the gold standard. With waning popularity of synthetic midurethral slings for the treatment of SUI, evidence-based assessment of AUS performance and safety is mandatory for patient counselling. OBJECTIVE: To conduct a systematic review of studies evaluating short- to long-term AUS performance and safety outcomes in non-neurogenic adult females with severe SUI. EVIDENCE ACQUISITION: PubMed/Medline, Embase, and the Cochrane Central Register of Controlled Trials were searched, from 1987 to 2018, without language restriction. Included studies had to report outcomes after AUS implantation in at least five adult women with non-neurogenic SUI, after a minimum follow-up of 6 months. EVIDENCE SYNTHESIS: Twelve articles collecting data from 886 patients were identified, no study being randomised or prospective. The reported zero pad rates ranged from 42% to 86%, revision rates from 6% to 44%, and mechanical failure rates from 2% to 41%. Procedure serious adverse event rates ranged from 2% to 54% and rates of serious adverse device effects such as explantation ranged from 2% to 27%. CONCLUSIONS: The level of evidence supporting the use of an AUS for non-neurogenic SUI in women is very low. AUS outcome assessments necessitate well-designed randomised trials, in accordance with current evidence-based medicine requirements. PATIENT SUMMARY: In this article, reviewing the scientific literature over the last 30 yr, we looked at the short- to long-term efficacy and safety of the artificial urinary sphincter in adult women for the treatment of severe urine leakage. We conclude that the data analysed provide very low evidence and that further well-conducted trials with large populations are required.