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

Sponsor
Ethicon, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04829994
Collaborator
(none)
195
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139.7
27.9
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Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Intervention

Study Design

Study Type:
Observational
Anticipated Enrollment :
195 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Long Term Prospective Post Market Clinical Follow-up (PMCF) of the GYNECARE TVT EXACT® Continence System for the Treatment of Stress Urinary Incontinence
Actual Study Start Date :
Jul 8, 2021
Anticipated Primary Completion Date :
Sep 30, 2032
Anticipated Study Completion Date :
Feb 27, 2033

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Patient Global Impression of Improvement (PGI-I) [Post-surgery through study completion, approximately 10 yrs]

  2. International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) [Baseline and post-surgery through study completion, approximately 10 yrs]

  3. Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) [Baseline and post-surgery through study, approximately 10 yrs completion]

  4. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke University Durham North Carolina United States 27707
2 Institute for Female Pelvic Medicine North Wales Pennsylvania United States 19454
3 UPMC Pittsburgh Pennsylvania United States 15213
4 Ordensklinikum Linz Linz Austria
5 Herlev Hospital Hillerod Denmark
6 Hopital Jeanne de Flandres Lille France
7 Karolinska Institute Stockholm Sweden

Sponsors and Collaborators

  • Ethicon, Inc.

Investigators

  • Study Director: Giovanni A Tommaselli, MD, Ethicon, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT04829994
Other Study ID Numbers:
  • ESC_2020_05
First Posted:
Apr 2, 2021
Last Update Posted:
Aug 9, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Ethicon, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 9, 2022