Artificial Urinary Sphincter Implants in Men: A National Health Care Data System-Based Study to Assess Reinterventions in France

Abstract

Purpose: Significant concerns remain regarding the long-term outcomes of American Medical Systems 800 artificial urinary sphincter (AUS) implants in men. The objective was to assess the long-term AUS reintervention (replacement or removal) rates after a first-ever AUS implantation.

Materials and methods: This population-based retrospective cohort study included all men age ≥ 18 years in France who underwent a first-ever AUS implantation (identified using a unique device identifier) for male stress urinary incontinence (SUI) after prostate cancer or benign prostatic hyperplasia (BPH) treatment, between January 1, 2006, and December 31, 2018. The primary outcome was reintervention-free survival rates (replacements and removals), estimated using the Kaplan-Meier method. Secondary outcomes were replacement and removal. A multivariable Cox proportional hazards model was used to assess associations between patient and hospital factors and the hazard of reintervention.

Results: The study included 8475 men with a median age of 69 years (IQR, 65-74) and a median follow-up time of 6 years (IQR, 3-9). Reintervention-free survival was 71% (95% CI, 70-72) at 2 years, 57% (95% CI, 55-58) at 5 years, and 40% (95% CI, 38-41) at 10 years. Reintervention-free survival was lower after BPH surgery, after radiotherapy combined with radical prostatectomy, and in centers performing fewer implantations. Removal-free survival was 83% (95% CI, 83%-84%) at 2 years, 75% (95% CI, 74%-76%) at 5 years, and 66% (95% CI, 65%-68%) at 10 years.

Conclusions: Among men undergoing AUS implantation for SUI because of prostate cancer or BPH treatment, the probability of reintervention was 29% within 2 years after implantation. The median time to reintervention was 6.6 years (IQR, 6.4-7.1), and the reintervention-free survival rate at 10 years was 40%. These insights can inform therapeutic decision-making for patients and surgeons during the management of male SUI.

Keywords: artificial; device removal; statistics & numerical data; follow-up studies; reoperation; statistics & numerical data; urinary incontinence; stress; surgery; humans/male/retrospective studies; urinary sphincter.