Adjustable Continence Therapy (ACT) for the Treatment of Female SUI

NARecruitingINTERVENTIONAL
Enrollment

167

Participants

Timeline

Start Date

January 26, 2021

Primary Completion Date

September 30, 2025

Study Completion Date

December 30, 2025

Conditions
Urinary IncontinenceUrinary Incontinence,Stress
Interventions
DEVICE

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).

Trial Locations (2)

68124

RECRUITING

CHI Health Research Center, Omaha

80045

RECRUITING

University of Colorado, Denver

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Uromedica

INDUSTRY

NCT04248283 - Adjustable Continence Therapy (ACT) for the Treatment of Female SUI | Biotech Hunter | Biotech Hunter