RecruitingNot ApplicableNCT04248283

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

A Clinical Investigation of the Adjustable Continence Therapy (ACT) for Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency

Sponsor

Uromedica

Enrollment

167 participants

Start Date

Jan 26, 2021

Study Type

INTERVENTIONAL

Conditions

Urinary Incontinence Urinary Incontinence, Stress

Summary

A prospective, single arm, non-randomized, multicenter, prospective case-series trial. The purpose of this trial is to demonstrate the safety and effectiveness of using the Adjustable Continence Therapy (ACT) to provide a clinically relevant improvement in stress urinary incontinence.

Eligibility

Sex: FEMALEMin Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Adjustable Continence Therapy for Women (ACT) for people with urinary incontinence and urinary incontinence, stress. The study is currently recruiting participants at 2 locations. People eligible for this study include women aged 22 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAdjustable 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).