Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ethicon, Inc.
Age
21–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study:
1. Stress urinary incontinence symptoms
2. Stress urinary incontinence confirmed by diagnostic evaluation of a cough stress test
3. Female subjects ≥ 21 years of age requiring treatment of SUI
4. Desired surgical correction of stress urinary incontinence using a synthetic pubo-urethral vaginal sling
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
You may not be if
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 pubo-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
Clareo Health | Post-Market Clinical Follow-Up onTVT EXACT® Continence System
