Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry
Condition(s) studied
Investigational drug(s) / intervention(s)
Intervention: There is no intervention, beyond necessary clinical care, in this registry. The surgical procedures being performed within the registry are identical to the surgical procedures patients would receive as part of SOC.
Study summary
The objective of this post market, clinical registry is to evaluate the performance of the products of the TVT family of products or vaginal vault or uterine prolapse repair (with laparotomic or laparoscopic approach including robotic assisted) using either Gynemesh PS Mesh or Artisyn Mesh in women undergoing surgery for SUI and POP.
Eligibility
Primary outcome measure(s)
- Stress Urinary Incontinence(SUI)- Cough Stress Test(CST) Assessment Change — Post-surgery through registry completion, approximately 5-10 yrs
Objective cure (success) approximately 5-10 years after surgery, defined as a negative standardized cough stress test (CST) - Pelvic Organ Prolapse (POP)- Physical Examination with Pelvic Organ Prolapse Quantification (POP-Q) Assessment Change — Post-surgery through registry completion, approximately 5-10 yrs
Objective cure (success) approximately 5-10 years after surgery, defined as the absence of prolapse beyond the hymen as determined by a physical examination with POP-Q
Trial sites (10)
| Facility | City | Region | Status |
|---|---|---|---|
| Yale University | New Haven | Connecticut | Recruiting |
| Duke University | Durham | North Carolina | Recruiting |
| University of Pennsylvania | Philadelphia | Pennsylvania | Recruiting |
| UPMC | Pittsburgh | Pennsylvania | Recruiting |
| Krankenhaus der barmherzigen Schwestern | Linz | Austria | Recruiting |
| Herlev Hospital | Hillerød | Denmark | Not Yet Recruiting |
| Hopital Jeanne de Flandres | Lille | France | Not Yet Recruiting |
| Universitatsklinikum Tubingen | Tübingen | Germany | Active Not Recruiting |
| Bio-Medical University Rome | Rome | Italy | Recruiting |
| Karolinska Institute | Stockholm | Sweden | 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 NCT04829175 on ClinicalTrials.gov ↗ ← All trials in Italy