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

NANot yet recruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

December 31, 2022

Primary Completion Date

April 30, 2024

Study Completion Date

December 31, 2034

Conditions
Stress Urinary Incontinence
Interventions
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"

Trial Locations (3)

28040

Hospital Clinico San Carlos, Madrid

Unknown

Thomayer hospital, Prague

08916

Hospital Germans Trias i Pujol, Barcelona

All Listed Sponsors
collaborator

EVAMED

OTHER

collaborator

Affluent Medical

INDUSTRY

lead

Myopowers Medical Technologies France SAS

INDUSTRY

NCT04827199 - Safety and Clinical Performance Study of the ARTUS® Artificial Urinary Sphincter (AUS) | Biotech Hunter | Biotech Hunter