Prospective registry for patients undergoing artificial urinary sphincter surgery for female stress urinary incontinence due to intrinsic sphincter deficiency: Study protocol.

BACKGROUND AND OBJECTIVE: Stress urinary incontinence (SUI) is a common yet often undertreated condition. While several treatment options exist for moderate SUI, women with severe incontinence - particularly due to intrinsic sphincter deficiency (ISD) or a fixed urethra - often have limited effective options after failed procedures. The artificial urinary sphincter (AUS) is the gold standard for severe incontinence in men, but its use in women remains limited due to surgical complexity, higher complication rates, and restricted availability to specialized centers. Consequently, high-quality evidence supporting its use in women is lacking. The VENUS registry aims to address this gap by collecting prospective, standardized data across multiple European centers.

METHODS: This is a prospective, non-controlled cohort study evaluating outcomes of AUS implantation in female patients using various surgical approaches (robot-assisted, laparoscopic, open, or other). Data will be collected across European centers (NCT04114266). The primary outcome is the cure rate of AUS implantation for female SUI due to ISD. Secondary outcomes include patient-reported outcomes, urodynamic and uroflowmetric changes, postoperative complications, and revision-free survival. The study aims to recruit 150 patients with a follow-up of 5 years.

CONCLUSION: The VENUS registry will provide real-world evidence on the safety and efficacy of AUS in women. Its findings may support broader adoption and future trials, while identifying clinical and surgical factors associated with successful outcomes, ultimately improving care for women with severe SUI.