RecruitingNot Applicable

Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System

United States, Italy, Switzerland195 participantsStarted 2021-09-09

Plain-language 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).

Who can participate

Age range

21 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Stress urinary incontinence symptoms
. Diagnostic evaluation, a positive cough stress rest, to confirm diagnosis of stress urinary incontinence.
. Female subjects ≥ 21 years of age requiring treatment of SUI
. Desired surgical correction of stress urinary incontinence using synthetic sub-urethral vaginal slings
. Planned surgery for primary stress incontinence without concomitant prolapse surgery
. Patient able and willing to participate in follow-up
. Subject or authorized representative has signed the approved informed consent

Exclusion criteria

. 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
. Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of study product
. History of previous synthetic, biologic or fascial sub-urethral sling

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cough Stress Test (CST) Assessment Change

Timeframe: Post-surgery through study completion, approximately 5-10 yrs

Trial details

NCT IDNCT04829357

SponsorEthicon, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2033-12-31

Contact for this trial

Christine Romanowski

908-808-6219 cromanow@its.jnj.com

View on ClinicalTrials.gov More Stress Urinary Incontinence trials