Post-Market Clinical Follow-Up onTVT EXACT® Continence System

Running, not enrolling

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 EXACT® Continence System in women undergoing retropubic mid-urethral sling surgery for Stress Urinary Incontinence (SUI).

Key facts

Study ID

NCT04829994

Run by

Ethicon, Inc.

People needed

198

Starts

2021-07-07

Expected to finish

2035-09-30

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
• Stress urinary incontinence confirmed by diagnostic evaluation of a cough stress test
• Female subjects ≥ 21 years of age requiring treatment of SUI
• Desired surgical correction of stress urinary incontinence using a synthetic pubo-urethral vaginal sling
• 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 pubo-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

• Duke University — Durham, North Carolina, United States
• Institute for Female Pelvic Medicine — North Wales, Pennsylvania, United States
• UPMC — Pittsburgh, Pennsylvania, United States
• Ordensklinikum Linz — Linz, Austria
• Herlev Hospital — Hillerød, Denmark
• Hopital Jeanne de Flandres — Lille, France
• Universitatsklinikum Tubingen — Tübingen, Germany
• Karolinska Institute — Stockholm, Sweden

Full record on ClinicalTrials.gov

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