Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry

Launched by ETHICON, INC. · Mar 31, 2021

Keywords

ClinConnect Summary

The Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry is a study designed to evaluate how well certain surgical products work for women with stress urinary incontinence (SUI) and pelvic organ prolapse (POP). Specifically, the trial is looking at the performance of mesh products used during surgery to help correct these conditions. If you are a woman aged 21 or older, have symptoms of SUI or POP, and are planning to have surgery using a specific type of synthetic mesh, you may be eligible to participate.

Participants in this trial can expect to undergo standard surgical procedures and will need to agree to follow-up visits to monitor their progress. It’s important to know that certain conditions, such as having had previous pelvic surgeries or being pregnant, would make someone ineligible for the study. The goal of this registry is to gather information that may help improve future treatments for SUI and POP, ultimately benefiting many women facing these issues.

Gender

FEMALE

Eligibility criteria

• 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