Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System
Recruiting
Observational Study
Stress Urinary Incontinence
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 21 and older
- Sex
- Female
- Study type
- Observational
- Participants needed
- 195 (estimated)
- Sponsor
- Ethicon, Inc. · Industry
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About This Trial
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).
Trial Locations
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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 ≥…
Contacts