Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry
NCT ID: NCT04829175
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2022-04-13
2036-08-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
SUI
1. Stress urinary incontinence symptoms
2. Urodynamic stress incontinence confirmed with urodynamic testing
3. Female patient ≥ 21 years of age
4. Desired surgical correction of SUI using synthetic pubo-urethral vaginal sling
5. Planned surgery for primary SUI
6. Patient able and willing to participate in follow-up
7. 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
1. 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
2. Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of registry products
3. History of previous synthetic, biologic or fascial sub-urethral sling (SUI) or pelvic mesh (POP)
4. Pregnancy or plans for future pregnancy
5. History of bleeding diathesis or current anti-coagulation therapy which cannot be suspended peri-operatively according to site's standard practice
6. Current genitourinary fistula or urethral diverticulum
7. Reversible cause of incontinence (i.e. drug effect) for SUI only
8. Severe vaginal atrophy
9. History of pelvic irradiation therapy
10. Contraindication to surgery
21 Years
FEMALE
No
Sponsors
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Ethicon, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Martin Weisberg, MD
Role: STUDY_DIRECTOR
Ethicon, Inc.
Locations
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Yale University
New Haven, Connecticut, United States
Duke University
Durham, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
UPMC
Pittsburgh, Pennsylvania, United States
Krankenhaus der barmherzigen Schwestern
Linz, , Austria
Herlev Hospital
Hillerød, , Denmark
Hopital Jeanne de Flandres
Lille, , France
Universitatsklinikum Tubingen
Tübingen, , Germany
Bio-Medical University Rome
Rome, , Italy
Żelazna Medical Center
Warsaw, , Poland
Karolinska Institute
Stockholm, , Sweden
Countries
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Central Contacts
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Other Identifiers
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ESC_2020_03
Identifier Type: -
Identifier Source: org_study_id