Status:
RECRUITING
Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry
Lead Sponsor:
Ethicon, Inc.
Conditions:
Stress Urinary Incontinence
Pelvic Organ Prolapse
Eligibility:
FEMALE
21+ years
Brief 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 lapar...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients who satisfy all of the following criteria will be considered eligible for enrollment in this registry:
- SUI
- Stress urinary incontinence symptoms
- Urodynamic stress incontinence confirmed with urodynamic testing
- Female patient ≥ 21 years of age
- Desired surgical correction of SUI using synthetic pubo-urethral vaginal sling
- Planned surgery for primary SUI
- Patient able and willing to participate in follow-up
- Patient or authorized representative has signed the approved Informed consent POP
- 1\. Uterine or vaginal vault prolapse symptoms 2. Urodynamic testing (optional) 3. Female patient ≥ 21 years of age 4. Desired surgical correction of POP using synthetic mesh 5. Planned surgery for uterine or vaginal vault prolapse with or without concomitant SUI surgery 6. Patient able and willing to participate in follow-up 7. Patient or authorized representative has signed the approved Informed consent
- Exclusion Criteria
- Patients meeting any of the following criteria will be considered not eligible for enrollment in this registry:
- Physical or psychological condition which would impair registry participation or are unwilling or unable to participate in all required registry visits and are unable to complete the questionnaires
- Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of registry products
- History of previous synthetic, biologic or fascial sub-urethral sling (SUI) or pelvic mesh (POP)
- Pregnancy or plans for future pregnancy
- History of bleeding diathesis or current anti-coagulation therapy which cannot be suspended peri-operatively according to site's standard practice
- Current genitourinary fistula or urethral diverticulum
- Reversible cause of incontinence (i.e. drug effect) for SUI only
- Severe vaginal atrophy
- History of pelvic irradiation therapy
- Contraindication to surgery
Exclusion
Key Trial Info
Start Date :
April 13 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 30 2036
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04829175
Start Date
April 13 2022
End Date
August 30 2036
Last Update
December 5 2025
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Yale University
New Haven, Connecticut, United States, 06510
2
Duke University
Durham, North Carolina, United States, 27707
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
4
UPMC
Pittsburgh, Pennsylvania, United States, 15213