Survival Without Reintervention of Second Artificial Urinary Sphincter Implants in Men: A National Healthcare Data System-Based Study in France.

Artificial urinary sphincter (AUS) is the gold standard treatment for severe male stress urinary incontinence (SUI). While survival outcomes after primary implantation are now well established, the prognosis following reintervention remains poorly understood. We aimed to assess long-term reintervention-free survival after a second AUS implantation and to compare outcomes between device replacement and reimplantation after removal. We performed a nationwide, population-based, retrospective cohort study including all men aged ≥18 years in France who underwent a second AUS implantation between 2006 and 2018 for SUI following prostate cancer or benign prostatic hyperplasia treatment. AUS procedures were identified through a unique device identifier. Of 5,132,311 eligible men, 8,475 received a first AUS and 1,619 a second AUS: 1,165 after device replacement and 454 after reimplantation following removal. The primary outcome was reintervention-free survival, estimated by Kaplan-Meier analysis. Secondary outcomes included replacement and removal rates. Predictors of reintervention were identified using multivariable Cox regression. Median follow-up was 53 months (IQR 26-81). Reintervention-free survival after second AUS was 81% (95% CI 79-83) at 2 years, 68% (95% CI 65-71) at 5 years, and 61% (95% CI 57-64) at 10 years. Device replacement achieved significantly better survival than reimplantation after removal (p <0.001). Notably, only 21% of patients whose first AUS was removed underwent reimplantation. Second AUS implantation provides durable long-term outcomes, approaching those of primary implants. The indication for reintervention critically influences prognosis, with replacement outperforming reimplantation after removal. The low reimplantation rate after AUS removal provides a clinically relevant piece of information to counsel patients requiring device removal.