Actively Recruiting
A Long Term Prospective Observational Post Market Clinical Follow-Up Registry of Ethicon Gynecare Pelvic Mesh Products for Stress Urinary Incontinence and Pelvic Organ Prolapse
Led by Ethicon, Inc. · Updated on 2026-06-05
1000
Participants Needed
10
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the performance of Ethicon Gynecare pelvic mesh products used in surgery for women with stress urinary incontinence (SUI) and pelvic organ prolapse (POP). It is a long-term prospective observational post market clinical registry that follows women undergoing surgical repair with either Gynemesh PS Mesh or Artisyn Mesh, including laparotomic, laparoscopic, or robotic-assisted approaches. The study focuses on women aged 21 years and older undergoing these procedures. The study does not involve any additional interventions beyond standard surgical care. Participants will have surgery using synthetic mesh slings or mesh for repair of SUI or POP, with or without combined procedures as planned by their doctors. The registry captures outcomes over a long period, approximately 5 to 10 years post-surgery, tracking changes in stress urinary incontinence using the cough stress test and pelvic organ prolapse using physical exam and quantification methods. Participants will be involved in follow-up visits where questionnaires assessing urinary symptoms, pelvic floor distress, sexual function, pain, and overall improvement will be completed from baseline through about 10 years after surgery. Researchers will monitor physical exam findings, symptom changes, and patient-reported outcomes to understand the long-term performance of these mesh products. The study also includes safety monitoring and long-term observation without additional treatment beyond standard care.
CONDITIONS
Brief Title
Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 21 years or older
- Symptoms of stress urinary incontinence with confirmed urodynamic testing
- Planned surgical correction of primary stress urinary incontinence using synthetic pubo-urethral vaginal sling
- Symptoms of uterine or vaginal vault prolapse
- Planned surgical correction of pelvic organ prolapse using synthetic mesh, with or without concomitant stress urinary incontinence surgery
- Ability and willingness to participate in follow-up visits
- Signed informed consent by patient or authorized representative
You will not qualify if you...
- Physical or psychological conditions impairing participation or inability to complete all required visits and questionnaires
- Any findings before or during surgery that prevent use of registry mesh products
- History of previous synthetic, biologic, or fascial sub-urethral sling or pelvic mesh surgery
- Pregnancy or plans for future pregnancy
- History of bleeding disorders or use of anticoagulation therapy that cannot be stopped as per site practice
- Current genitourinary fistula or urethral diverticulum
- Reversible causes of incontinence such as medication effects (for stress urinary incontinence only)
- Severe vaginal atrophy
- History of pelvic irradiation therapy
- Contraindication to surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to discharge from hospital
Participants undergo routine surgical procedures with synthetic mesh for stress urinary incontinence or pelvic organ prolapse, followed by immediate post-operative care.
1 surgical visit and immediate recovery period
Duration - Approximately 5 to 10 years
Participants who undergo routine care are observed over approximately 5 to 10 years to assess changes and outcomes related to their surgery using questionnaires and physical exams.
Multiple follow-up visits over 5 to 10 years
Trial Site Locations
Total: 10 locations
1
Yale University
New Haven, Connecticut, United States, 06510
Actively Recruiting
2
Duke University
Durham, North Carolina, United States, 27707
Actively Recruiting
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
4
UPMC
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
5
Krankenhaus der barmherzigen Schwestern
Linz, Austria
Actively Recruiting
6
Herlev Hospital
Hillerød, Denmark
Not Yet Recruiting
7
Hopital Jeanne de Flandres
Lille, France
Not Yet Recruiting
8
Universitatsklinikum Tubingen
Tübingen, Germany
Actively Recruiting
9
Bio-Medical University Rome
Rome, Italy
Actively Recruiting
10
Karolinska Institute
Stockholm, Sweden
Actively Recruiting
Research Team
C
Christine Romanowski
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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