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

Recruiting

• Conditions: Stress Urinary Incontinence

• Registration Number: NCT04829994
• Lead Sponsor: Ethicon, Inc.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-17
• Study First Submitted QC: 2021-03-31
• Study First Posted: 2021-04-02
• Study Start: 2021-07-08
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-25
• Primary Completion: 2035-09-30
• Study Completion: 2036-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 195

Inclusion Criteria

Subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study:

1. Stress urinary incontinence symptoms
2. Stress urinary incontinence confirmed by diagnostic evaluation of a cough stress test
3. Female subjects ≥ 21 years of age requiring treatment of SUI
4. Desired surgical correction of stress urinary incontinence using a synthetic pubo-urethral vaginal sling
5. Planned surgery for primary stress incontinence without concomitant prolapse surgery
6. Patient able and willing to participate in follow-up
7. Subject or authorized representative has signed the approved informed consent

Exclusion Criteria

Subjects meeting any of the following criteria will be considered not eligible for enrollment in this study:

1. 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
2. Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of study product
3. History of previous synthetic, biologic or fascial pubo-urethral sling
4. Pregnancy or plans for future pregnancy
5. History of bleeding diathesis or current anti-coagulation therapy which cannot be suspended peri-operatively according to site's standard practice.
6. Current genitourinary fistula or urethral diverticulum
7. Reversible cause of incontinence (i.e. drug effect)
8. Contraindication to surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cough Stress Test (CST) Assessment Change	Post-surgery through study completion, approximately 5-10 yrs	Objective cure of Stress Urinary Incontinence (SUI) (treatment success) sproximately 5-10 years after surgery, defined as a negative CST

Secondary Outcome Measures

Name	Time	Method
Patient Global Impression of Improvement (PGI-I)	Post-surgery through study completion, approximately 10 yrs
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)	Baseline and post-surgery through study completion, approximately 10 yrs
Wong-Baker FACES® Pain Rating Scale	Post-surgery through study completion, approximately 10 yrs	To assess pain on a scale from 0 (no pain) to 10 (worst pain) related to study device or procedure
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)	Baseline and post-surgery through study, approximately 10 yrs completion

Trial Locations

Locations (8)

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; 🇩🇰 Hillerod, Denmark

Hopital Jeanne de Flandres; 🇫🇷 Lille, France

Universitatsklinikum Tubingen; 🇩🇪 Tubingen, Germany

Karolinska Institute; 🇸🇪 Stockholm, Sweden