Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry
United States, Austria1,000 participantsStarted 2022-04-11
Plain-language 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.
Who can participate
Age range21 Years
SexFEMALE
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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