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

NCT04829994 | Active Not Recruiting FDA Device

• 1 other identifier: ESC_2020_05
• Study Type: observational
• Target: 198
• Locations: 6 countries
• Sites: 8

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).

Conditions

Stress Urinary Incontinence

Keywords

GYNECARE TVT EXACT® Continence System; SUI

Outcome Measures

Primary Outcomes (1)

• Cough Stress Test (CST) Assessment Change

  Objective cure of Stress Urinary Incontinence (SUI) (treatment success) sproximately 5-10 years after surgery, defined as a negative CST

  Post-surgery through study completion, approximately 5-10 yrs

Secondary Outcomes (4)

• 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

• Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)

  Baseline and post-surgery through study, approximately 10 yrs completion

• Wong-Baker FACES® Pain Rating Scale

  Post-surgery through study completion, approximately 10 yrs

Interventions

Intervention DEVICE

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 subjects would receive as part of SOC.

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: Female subjects ≥ 21 years of age
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female subjects ≥ 21 years of age with a diagnosis of SUI, resulting from utrethral hypermobility and/or intrinsic sphincter deficiency.

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

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (8)

Duke University

Durham, North Carolina, 27707, United States

Location

Institute for Female Pelvic Medicine

North Wales, Pennsylvania, 19454, United States

Location

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Ordensklinikum Linz

Linz, Austria

Location

Herlev Hospital

Hillerød, Denmark

Location

Hopital Jeanne de Flandres

Lille, France

Location

Universitatsklinikum Tubingen

Tübingen, Germany

Location

Karolinska Institute

Stockholm, Sweden

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Methods

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Martin Weisberg, MD

  Ethicon, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: April 2, 2021
• Study Start: July 8, 2021
• Primary Completion (Estimated): September 30, 2035
• Study Completion (Estimated): February 28, 2036
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

DK (1); DE (1); SE (1); AU (1); FR (1); US (3)