167
Participants
Start Date
January 26, 2021
Primary Completion Date
September 30, 2025
Study Completion Date
December 30, 2025
Adjustable Continence Therapy for Women (ACT)
Two ACT devices are implanted in each patient. The devices are intended for implantation in the paraurethral space, with the balloons located on each side of the urethra near the bladder neck. The ports are placed subcutaneously in the labia majora. The balloons are filled after implantation with an isotonic solution via needle injection into the port. The ACT implant can be placed using local, spinal or general anesthesia with the surgical instruments (provided separately).
RECRUITING
CHI Health Research Center, Omaha
RECRUITING
University of Colorado, Denver
Lead Sponsor
Uromedica
INDUSTRY