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

Stress Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04829994
• Other study ID #: ESC_2020_05
• Status: Recruiting
• Start date: July 8, 2021
• Est. completion date: February 27, 2035

Study information

• Verified date: June 2024
• Source: Ethicon, Inc.
• Contact: Christine Romanowski
• Phone: 908-808-6219
• Email: cromanow[@]iits.jnj.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 195
• Est. completion date: February 27, 2035
• Est. primary completion date: September 30, 2034
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Austria	Ordensklinikum Linz	Linz
Denmark	Herlev Hospital	Hillerod
France	Hopital Jeanne de Flandres	Lille
Germany	Universitatsklinikum Tubingen	Tubingen
Sweden	Karolinska Institute	Stockholm
United States	Duke University	Durham	North Carolina
United States	Institute for Female Pelvic Medicine	North Wales	Pennsylvania
United States	UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon, Inc.

Countries where clinical trial is conducted

United States,  Austria,  Denmark,  France,  Germany,  Sweden, 

Outcome

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