Post Market Clinical Follow-up Study on TVT ABBREVO® 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 the 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 ABBREVO® Continence System in women undergoing 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) approximately 5-10 years after surgery, defined as a negative CST
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| Institute for Female Pelvic Medicine | North Wales | Pennsylvania | Recruiting |
| Bio-Medical University Rome | Rome | Italy | Recruiting |
| Ospedale San Pietro Fatebenefratelli | Rome | Italy | Recruiting |
| Ospedale Regionale Beata Vergine | Mendrisio | Switzerland | Recruiting |
More Ethicon, Inc. trials in Italy
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 NCT04829357 on ClinicalTrials.gov ↗ ← All trials in Italy