Registry to evaluate pelvic mesh products for urinary incontinence and prolapse

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Bio-Medical University Rome
  Rome, Italy Recruiting

Study contacts

• Study coordinator: Christine Romanowski
• Email: cromanow@its.jnj.com
• Phone: 908-808-6219

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Centered Surgery: Preoperative Counseling to Improve Patient Satisfaction

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.