The Artificial Urinary Sphincter After a Quarter of a Century: A Critical Systematic Review of Its Use in Male Non-neurogenic Incontinence

Abstract

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of AUS in non-neurogenic male patients with SUI is low, based on heterogeneous data, low-quality studies, and mostly out-of-date efficacy outcome criteria.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.

Introduction

The artificial urinary sphincter (AUS) has been used since 1972 for the treatment of severe urinary incontinence [1]. After several technical evolutions that led to significant improvement of surgical and functional results, the device reached maturity in 1987 with the release of the narrow-back cuff (NBC) AMS800 device (AMS, Minnetonka, MN, USA) [2]. The device is largely unchanged in current practice apart from small changes (eg, antibiotic coating). Some innovative devices such as FlowSecure and Zephyr ZSI 375 have been presented as potential alternatives, but only a few preliminary results are available [3], [4]. It is currently estimated that >150 000 patients worldwide have been implanted with an AUS, the vast majority with AMS800 [5]. This large number of cases, potentially with extremely long follow-up, is barely reflected in the literature, and most data on AUS outcomes come from older retrospective cohort studies. Randomized controlled trials (RCTs) were not performed due to the lack of a comparator [5]. Nonetheless, AUS implantation has been the standard of care for refractory male stress urinary incontinence (SUI) for a considerable time.

In recent years, new surgical alternatives claim to be safe and effective [6], [7]. Among these new devices, male slings are increasingly used and have been given the same level of recommendation (grade B) as AUS, according to the 2012 European Association of Urology guidelines [5]. However, given the respective histories of the two techniques and the differing profiles of the most suitable patients, the equivalent grading of their recommendation obscures an uncertain picture.

To clarify this situation and pave the way for a reliable comparison between AUS and other options, our objective was to conduct a systematic review of AUS efficacy and safety outcomes in the context of non-neurogenic male SUI management after a minimum follow-up of 2 yr. Concurrently, we compared the evidence available with the currently active recommendations about clinical research in the field of SUI, to elaborate the apparent strengths and weaknesses of AUS in the contemporary era.