Actively Recruiting
Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry
Led by Ethicon, Inc. · Updated on 2026-05-08
1000
Participants Needed
10
Research Sites
833 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 (SUI) confirmed by urodynamic testing
- Planned surgical correction of primary SUI using synthetic pubo-urethral vaginal sling
- Ability and willingness to participate in follow-up and sign informed consent
- Symptoms of uterine or vaginal vault prolapse
- Planned surgery for uterine or vaginal vault prolapse with or without concurrent SUI surgery using synthetic mesh
- Ability and willingness to participate in follow-up and sign informed consent
You will not qualify if you...
- Physical or psychological conditions preventing participation or questionnaire completion
- Pre-operative or intra-operative findings that prevent use of registry products
- History of previous synthetic, biologic, or fascial sub-urethral sling or pelvic mesh surgery
- Current pregnancy or plans for future pregnancy
- History of bleeding disorders or current anticoagulation therapy that cannot be paused
- Current genitourinary fistula or urethral diverticulum
- Reversible causes of incontinence such as drug effects for SUI only
- Severe vaginal atrophy
- History of pelvic irradiation therapy
- Contraindications to surgery
AI-Screening
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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
CONTACT
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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