NCT04827199

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

Safety and Clinical Performance Study of the ARTUS® Artificial Urinary Sphincter (AUS) for the Treatment of Stress Urinary Incontinence (SUI) Due to Intrinsic Sphincter Deficiency

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Myopowers Medical Technologies France SAS · Industry
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Artificial Urinary Sphincter implantation	Device preparation (recharge, settings, pairing) Patient preparation Calibration procedure (to verify the device is in full working prior to implantation) Implantation procedure which includes: * Perineal approach and bulbar urethral dissection * Inguinal approach * Cuff implantation around the urethra * Transmission cable passing * Surgery test procedure * Implantation of the Control Unit * Closure of the inguinal incision * Closure of the perineal incision * "Implant disabled mode" activation

Timeline

• Start date: 2022-12-01
• Primary completion: 2024-04-01
• Completion: 2034-12-01
• First posted: 2021-04-01
• Last updated: 2022-09-19

Locations

3 sites across 2 countries: Czechia, Spain