RecruitingNCT04829357

Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System

A Long Term Prospective Post Market Clinical Follow-up (PMCF) of the GYNECARE TVT ABBREVO® Continence System for the Treatment of Stress Urinary Incontinence

Sponsor

Ethicon, Inc.

Enrollment

195 participants

Start Date

Sep 9, 2021

Study Type

OBSERVATIONAL

Conditions

Stress Urinary Incontinence

Summary

The objective of this single arm, post market, clinical study is to evaluate the performance of Gynecare TVT ABBREVO® Continence System in women undergoing Mid-urethral sling surgery for Stress Urinary Incontinence (SUI).

Eligibility

Sex: FEMALEMin Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Intervention for people with stress urinary incontinence. The study is currently recruiting participants at 4 locations. People eligible for this study include women aged 21 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

DEVICEIntervention

There is no intervention, beyond necessary clinical care, in this study. The surgical procedures being performed within the study are identical to the surgical procedures the subjects would receive as part of SOC.