Evaluating Adjustable Continence Therapy Devices for Female Stress Urinary Incontinence Caused by Intrinsic Sphincter Deficiency

What this Trial Is About

This research aims to evaluate the safety and effectiveness of Adjustable Continence Therapy ACT in treating female stress urinary incontinence caused by intrinsic sphincter deficiency. The trial is a prospective, single-arm, non-randomized, multicenter case-series study designed to demonstrate clinically relevant improvement in this condition. Participants will receive implantation of two ACT devices placed near the urethra and bladder neck, with ports under the skin of the labia majora. The balloons are filled with an isotonic solution after implantation using needle injection. The device can be implanted under local, spinal, or general anesthesia with specialized surgical instruments. This is the only intervention during the trial. Throughout the study, participants will be monitored for changes in provocative pad weight over 12 months as the primary outcome. Secondary assessments include quality of life and urogenital distress questionnaires. Participants must comply with follow-up visits and assessments to evaluate treatment effects and safety. The total study duration extends up to 12 months after device implantation.

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