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

NCT ID: NCT04829994

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

198 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-08

Study Completion Date

2036-02-28

Brief Summary

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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

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Conditions

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Stress Urinary Incontinence

Keywords

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GYNECARE TVT EXACT® Continence System SUI

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Intervention

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ethicon, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Weisberg, MD

Role: STUDY_DIRECTOR

Ethicon, Inc.

Locations

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Duke University

Durham, North Carolina, United States

Site Status

Institute for Female Pelvic Medicine

North Wales, Pennsylvania, United States

Site Status

UPMC

Pittsburgh, Pennsylvania, United States

Site Status

Ordensklinikum Linz

Linz, , Austria

Site Status

Herlev Hospital

Hillerød, , Denmark

Site Status

Hopital Jeanne de Flandres

Lille, , France

Site Status

Universitatsklinikum Tubingen

Tübingen, , Germany

Site Status

Karolinska Institute

Stockholm, , Sweden

Site Status

Countries

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United States Austria Denmark France Germany Sweden

Other Identifiers

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ESC_2020_05

Identifier Type: -

Identifier Source: org_study_id