Status:
ACTIVE_NOT_RECRUITING
Post-Market Clinical Follow-Up onTVT EXACT® Continence System
Lead Sponsor:
Ethicon, Inc.
Conditions:
Stress Urinary Incontinence
Eligibility:
FEMALE
21+ years
Brief 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 Stre...
Eligibility Criteria
Inclusion
- Subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study:
- 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
- Subjects meeting any of the following criteria will be considered not eligible for enrollment in this study:
- 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.
- Current genitourinary fistula or urethral diverticulum
- Reversible cause of incontinence (i.e. drug effect)
- Contraindication to surgery
Key Trial Info
Start Date :
July 8 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2036
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT04829994
Start Date
July 8 2021
End Date
February 28 2036
Last Update
December 5 2025
Active Locations (8)
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1
Duke University
Durham, North Carolina, United States, 27707
2
Institute for Female Pelvic Medicine
North Wales, Pennsylvania, United States, 19454
3
UPMC
Pittsburgh, Pennsylvania, United States, 15213
4
Ordensklinikum Linz
Linz, Austria