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NCT04829175Recruiting

Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry

Ethicon, Inc.

Start Date

4/11/2022

Completion Date

3/31/2038

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 Criteria

Age Range: 21 years to No maximum

Inclusion Criteria: Patients who satisfy all of the following criteria will be considered eligible for enrollment in this registry: 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 Patients meeting any of the following criteria will be considered not eligible for enrollment in this registry: 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

Interventions

DEVICE

Intervention

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Conditions

Stress Urinary IncontinencePelvic Organ Prolapse

Locations

Yale University

New Haven, Connecticut 06510

United States

Duke University

Durham, North Carolina 27707

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

UPMC

Pittsburgh, Pennsylvania 15213

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

Karolinska Institute

Stockholm,

Sweden