NCT04829175 Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry
| NCT ID | NCT04829175 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ethicon, Inc. |
| Condition | Stress Urinary Incontinence |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2022-04-11 |
| Primary Completion | 2033-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2022-04-11 with a primary completion date of 2033-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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
Contact & Investigator
Martin Weisberg, MD
STUDY DIRECTOR
Ethicon, Inc.
Frequently Asked Questions
Who can join the NCT04829175 clinical trial?
This trial is open to female participants only, aged 21 Years or older, studying Stress Urinary Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04829175 currently recruiting?
Yes, NCT04829175 is actively recruiting participants. Contact the research team at cromanow@its.jnj.com for enrollment information.
Where is the NCT04829175 trial being conducted?
This trial is being conducted at New Haven, United States, Durham, United States, Philadelphia, United States, Pittsburgh, United States and 6 additional locations.
Who is sponsoring the NCT04829175 clinical trial?
NCT04829175 is sponsored by Ethicon, Inc.. The principal investigator is Martin Weisberg, MD at Ethicon, Inc.. The trial plans to enroll 1,000 participants.