Safety and Effectiveness Study of the UrOActive Artificial Urinary Sphincter for Treating Stress Urinary Incontinence in Men

What this Trial Is About

This research aims to assess the safety and effectiveness of the UrOActive4 Artificial Urinary Sphincter AUS device in men diagnosed with stress urinary incontinence SUI. It is a prospective, multicenter, single-arm clinical study focused on evaluating this device in appropriate surgical candidates. The study is sponsored by UroMems SAS and targets adult men aged 22 years or older who have experienced SUI for at least six months. Participants who meet the eligibility requirements will receive the UroActive AUS implant during the study. The treatment involves surgically implanting the device, which is designed to manage stress urinary incontinence symptoms. There are no comparator groups as this is a single-arm study. The trial focuses on monitoring the safety and effectiveness of the device over time. During the study, participants will be assessed for their response to the implant, with a key measurement being the responder rate at 26 weeks after the device activation. Researchers will evaluate outcomes related to urinary control and any potential safety concerns. The study will continue through 2031, providing long-term observation of participants progress following the implantation.

A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)