RecruitingNot ApplicableNCT03767595

ProACT Post-Approval Study

Post Approval Study of the ProACT™ Adjustable Continence Therapy for Men

Sponsor

Uromedica

Enrollment

145 participants

Start Date

Feb 19, 2019

Study Type

INTERVENTIONAL

Conditions

Stress Urinary Incontinence

Summary

The ProACT Post Approval Study is a 5-year prospective, open-label, multi-center study designed to evaluate the long-term incidence of urethral stricture and device erosion after ProACT implantation. In addition, the study will evaluate whether treatment with ProACT affects clinical outcomes after subsequent SUI therapies.

Eligibility

Sex: MALEMin Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called ProACT Adjustable Continence Therapy for Men for people with stress urinary incontinence. The study is currently recruiting participants at 6 locations. People eligible for this study include men aged 50 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

DEVICEProACT Adjustable Continence Therapy for Men

The ProACT therapy consists of two small, adjustable silicone balloons connected with tubing to a port. During a minimally invasive outpatient procedure, the balloons are surgically placed in the area where the prostate was removed or resected.