NCT04829357 Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System
| NCT ID | NCT04829357 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ethicon, Inc. |
| Condition | Stress Urinary Incontinence |
| Study Type | OBSERVATIONAL |
| Enrollment | 195 participants |
| Start Date | 2021-09-09 |
| Primary Completion | 2033-12-31 |
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 195 participants in total. It began in 2021-09-09 with a primary completion date of 2033-12-31.
⚠ 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 single arm, post market, clinical study is to evaluate the performance of Gynecare TVT ABBREVO® Continence System in women undergoing Mid-urethral sling surgery for Stress Urinary Incontinence (SUI).
Eligibility Criteria
Inclusion Criteria: Subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study: 1. Stress urinary incontinence symptoms 2. Diagnostic evaluation, a positive cough stress rest, to confirm diagnosis of stress urinary incontinence. 3. Female subjects ≥ 21 years of age requiring treatment of SUI 4. Desired surgical correction of stress urinary incontinence using synthetic sub-urethral vaginal slings 5. Planned surgery for primary stress incontinence without concomitant prolapse surgery 6. Patient able and willing to participate in follow-up 7. Subject or authorized representative has signed the approved informed consent Exclusion Criteria Subjects meeting any of the following criteria will be considered not eligible for enrollment in this study: 1. Physical or psychological condition which would impair study participation or are unwilling or unable to participate in all required study 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 study product 3. History of previous synthetic, biologic or fascial sub-urethral sling 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) 8. Contraindication to surgery
Contact & Investigator
Martin Weisberg, MD
STUDY DIRECTOR
Ethicon, Inc.
Frequently Asked Questions
Who can join the NCT04829357 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 NCT04829357 currently recruiting?
Yes, NCT04829357 is actively recruiting participants. Contact the research team at cromanow@its.jnj.com for enrollment information.
Where is the NCT04829357 trial being conducted?
This trial is being conducted at North Wales, United States, Rome, Italy, Rome, Italy, Mendrisio, Switzerland.
Who is sponsoring the NCT04829357 clinical trial?
NCT04829357 is sponsored by Ethicon, Inc.. The principal investigator is Martin Weisberg, MD at Ethicon, Inc.. The trial plans to enroll 195 participants.