Post-Market Clinical Follow-Up onTVT EXACT® Continence System
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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
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