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
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