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

Recruiting now

Conditions studied: Stress Urinary Incontinence

In brief

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).

Key facts

Study ID

NCT04829357

Run by

Ethicon, Inc.

People needed

195

Starts

2021-09-09

Expected to finish

2038-12-31

Last updated by the study team

2026-07-06

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Institute for Female Pelvic Medicine — North Wales, Pennsylvania, United States (enrolling)
• Bio-Medical University Rome — Rome, Italy (enrolling)
• Ospedale San Pietro Fatebenefratelli — Rome, Italy (enrolling)
• Ospedale Regionale Beata Vergine — Mendrisio, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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