The SAFER study (Systematic Assessment of Artificial Urinary Sphincter Failure and Erosion Recovery)

Urinary incontinence is a prevalent and distressing condition that significantly impacts the quality of life of affected patients. The artificial urinary sphincter (AUS) has emerged as a cornerstone in managing moderate to severe urinary incontinence in males. However, despite several incremental improvements over the years, complications such as mechanical failure, suboptimal functional results, infection, and urethral erosion still raise significant challenges.

Wed, 14 Feb 2024 • Asst. Prof. Mikołaj Frankiewicz, Dept. of Urology, Medical University of Gdańsk (PL)
LUTSSAFER Study InitiativeIncontinenceYAU Reconstructive Working Group

Artificial urinary sphincter revisions resulting from atrophy and erosion have outnumbered mechanical AUS failures over the past 20 years and account for up to 5% of patients post-AUS implantation. Addressing this issue is particularly challenging due to the cases' complexity. As expected, durability and continence outcomes after AUS revisions following erosions are worse than for AUS revisions for any other cause.

Moreover, the development of urethral stricture after subsequent repair of the urethral defect further complicates the clinical course of an AUS cuff erosion. Despite the noticeable prevalence of this complication, there is a lack of standardisation of treatment protocols. Given the rise in number of AUS revisions following erosions, it is necessary to develop a standardised approach providing patients the best chance for return to continence and satisfactory urethra patency despite limited amount of healthy urethral tissue.

SAFER study initiative
The SAFER study, an acronym for Systematic Assessment of Artificial Urinary Sphincter Failure and Erosion Recovery, is an initiative of Trauma and Reconstructive Urology Working Party of the European Association of Urology Young Academic Urologists to conduct a retrospective cohort investigation, designed to elucidate the most effective treatment modalities for the erosion of AUS.

Predicated on the analysis of historical patient data, the research seeks to comparatively assess the outcomes of different therapeutic approaches to AUS erosion. By examining a breadth of factors, from patient demographics to post-treatment complications, the SAFER study aims to forge a path towards optimised, evidence-based care strategies that enhance patient quality of life and offer substantial insights into the mitigation of AUS-related complications. Given the challenges and varied approaches in AUS erosion treatment, there is a clear need for standardisation that could lead to more consistent outcomes and improved patient experiences.

Invitations for the multicentre SAFER study will be issued soon. We welcome and encourage interested researchers and institutions to participate in this significant research initiative. If you are keen to contribute, please reach out to us via email for further details and collaboration opportunities.

Artificial urinary sphincter erosion is a significant complication in the management of male stress urinary incontinence. Despite its prevalence, there is a lack of standardisation in its treatment. Following the need for a more standardised approach, future research should focus on developing and validating standardised treatment protocols for AUS erosion.


This article first appeared in the January-February 2024 edition of European Urology Today. Read the full article here.