70
Participants
Start Date
December 31, 2022
Primary Completion Date
April 30, 2024
Study Completion Date
December 31, 2034
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"
Hospital Clinico San Carlos, Madrid
Thomayer hospital, Prague
Hospital Germans Trias i Pujol, Barcelona
Lead Sponsor
Collaborators (1)
EVAMED
OTHER
Affluent Medical
INDUSTRY
Myopowers Medical Technologies France SAS
INDUSTRY