Registry to evaluate pelvic mesh products for urinary incontinence and prolapse

A Long Term Prospective Observational Post Market Clinical Follow-Up (PMCF) Registry of Ethicon Gynecare Pelvic Mesh Products for The Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse

This study is testing how well certain surgical mesh products work for women having surgery for urinary incontinence and pelvic organ prolapse, while also looking at their safety and any complications after the surgery.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 21 Years and up
• Sex: Female
• Sponsor: Ethicon, Inc. (Industry-sponsored)
• Locations: 10 sites (New Haven, Connecticut and 9 other locations)
• Trial ID: NCT04829175 on ClinicalTrials.gov

What this trial studies

This observational registry aims to assess the performance of the TVT family of products and synthetic mesh used in surgeries for stress urinary incontinence (SUI) and pelvic organ prolapse (POP). It includes women who are undergoing surgical correction for these conditions, with a focus on the effectiveness and safety of the Gynemesh PS Mesh and Artisyn Mesh. Participants will be followed up post-surgery to gather data on outcomes and any complications that may arise. The study is designed to provide insights into the long-term performance of these surgical interventions.

Who should consider this trial

Good fit: Ideal candidates are women aged 21 and older with confirmed stress urinary incontinence or pelvic organ prolapse who are planning to undergo surgical correction.

Not a fit: Patients who do not have stress urinary incontinence or pelvic organ prolapse, or those who are not planning to undergo surgery, may not benefit from this registry.

Why it matters

Potential benefit: If successful, this registry could enhance the understanding of pelvic mesh products, leading to improved surgical outcomes for women with SUI and POP.

How similar studies have performed: Other studies evaluating pelvic mesh products have shown varying degrees of success, but this registry focuses specifically on post-market performance, making it a valuable addition to existing research.

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

Where this trial is running

New Haven, Connecticut and 9 other locations

• Yale University — New Haven, Connecticut, United States (Recruiting)
• Duke University — Durham, North Carolina, United States (Recruiting)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
• Upmc — Pittsburgh, Pennsylvania, United States (Recruiting)
• Krankenhaus der barmherzigen Schwestern — Linz, Austria (Recruiting)
• Herlev Hospital — Hillerød, Denmark (Not_yet_recruiting)
• Hopital Jeanne de Flandres — Lille, France (Not_yet_recruiting)
• Universitatsklinikum Tubingen — Tübingen, Germany (Recruiting)
• Bio-Medical University Rome — Rome, Italy (Recruiting)
• Karolinska Institute — Stockholm, Sweden (Recruiting)

Study contacts

• Study coordinator: Christine Romanowski

Conditions Stress Urinary Incontinence; Pelvic Organ Prolapse; SUI; POP