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

Inclusion Criteria8

Subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study:
Stress urinary incontinence symptoms
Diagnostic evaluation, a positive cough stress rest, to confirm diagnosis of stress urinary incontinence.
Female subjects ≥ 21 years of age requiring treatment of SUI
Desired surgical correction of stress urinary incontinence using synthetic sub-urethral vaginal slings
Planned surgery for primary stress incontinence without concomitant prolapse surgery
Patient able and willing to participate in follow-up
Subject or authorized representative has signed the approved informed consent

Exclusion Criteria9

Subjects meeting any of the following criteria will be considered not eligible for enrollment in this study:
Physical or psychological condition which would impair study participation or are unwilling or unable to participate in all required study visits and are unable to complete the questionnaires
Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of study product
History of previous synthetic, biologic or fascial sub-urethral sling
Pregnancy or plans for future pregnancy
History of bleeding diathesis or current anti-coagulation therapy which cannot be suspended peri-operatively according to site's standard practice.
Current genitourinary fistula or urethral diverticulum
Reversible cause of incontinence (i.e. drug effect)
Contraindication to surgery

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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.