Post-Market Clinical Follow-Up onTVT EXACT® Continence System
United States, Austria, Denmark198 participantsStarted 2021-07-07
Plain-language summary
The objective of this single arm, post market, clinical study is to evaluate the performance of Gynecare TVT EXACT® Continence System in women undergoing retropubic mid-urethral sling surgery for Stress Urinary Incontinence (SUI).
Who can participate
Age range21 Years
SexFEMALE
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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
✓. Stress urinary incontinence confirmed by diagnostic evaluation of a cough stress test
✓. Female subjects ≥ 21 years of age requiring treatment of SUI
✓. Desired surgical correction of stress urinary incontinence using a synthetic pubo-urethral vaginal sling
✓. 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 pubo-urethral sling
✕. Pregnancy or plans for future pregnancy
✕. History of bleeding diathesis or current anti-coagulation therapy which cannot be suspended peri-operatively according to site's standard practice.
What they're measuring
1
Cough Stress Test (CST) Assessment Change
Timeframe: Post-surgery through study completion, approximately 5-10 yrs