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Active, not recruiting Observational

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

NCT04829994 · tracked via the Priya Life Science Denmark tracker
Phase
Observational
Started
2021-07-07
Last updated
2026-07-06

Condition(s) studied

Stress Urinary Incontinence

Investigational drug(s) / intervention(s)

Intervention

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.

Study 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).

Eligibility

Sex
FEMALE
Min age
21 Years
Max age
—
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

Primary outcome measure(s)

  • 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

Trial sites (8)

FacilityCityRegionStatus
Duke University Durham North Carolina
Institute for Female Pelvic Medicine North Wales Pennsylvania
UPMC Pittsburgh Pennsylvania
Ordensklinikum Linz Linz Austria
Herlev Hospital Hillerød Denmark
Hopital Jeanne de Flandres Lille France
Universitatsklinikum Tubingen Tübingen Germany
Karolinska Institute Stockholm Sweden

More Ethicon, Inc. trials in Denmark

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04829994 on ClinicalTrials.gov ↗ ← All trials in Denmark