Safety and Clinical Performance Study of the ARTUS® Artificial Urinary Sphincter (AUS)

This clinical investigation is designed as an interventional, prospective, non-randomized, open-label, single arm, multicentric and international study for obtaining CE marking. The study will be the first performed with the ARTUS® medical device aiming to assess safety and performance and will be composed of three phases: * pilot phase (with safety analysis on the 10 first included subjects in 3 investigational sites), * pivotal phase (in up to 16 investigational sites with a follow-up until the 12-month post-device activation visit, including an interim analysis at 3-month post-device activation visit on performance and safety), * long-term phase (with a long-term follow-up until 10 years post implantation in up to 16 investigational sites). The objectives is to assess safety and clinical performance of the ARTUS® for the treatment of Stress Urinary Incontinence at short and long-term.

NCT Number	NCT04827199
Lead Sponsor	Myopowers Medical Technologies France SAS Collaborators: EVAMED, Affluent Medical
Conditions	Stress Urinary Incontinence
Enrollment	70 participants
Start Date	2022-12
Primary Completion	2024-04 (estimated)
Study Completion	2034-12 (estimated)
Updated on ClinicalTrials.gov	2022-09-19