Post-Market Clinical Follow-Up onTVT EXACT® Continence System

Launched by ETHICON, INC. · Mar 31, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at the Gynecare TVT EXACT® Continence System, which is a treatment for women with Stress Urinary Incontinence (SUI). SUI is when a woman experiences leaking of urine when she coughs, laughs, or exercises. The study aims to see how well this treatment works for women who are planning to have surgery specifically to fix this issue using a special type of supportive mesh called a sling.

To participate in the trial, women need to be at least 21 years old, have symptoms of SUI confirmed by a test where they cough, and should be planning to have surgery without any other procedures at the same time. It's important that participants are able to attend follow-up appointments and complete questionnaires about their experience. Women who have certain medical conditions or previous surgeries related to this problem may not be eligible. Those who join the trial can expect regular check-ins to see how the treatment is working for them.

Gender

FEMALE

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. 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
• Exclusion Criteria:
• Subjects meeting any of the following criteria will be considered not eligible for enrollment in this study:
• • 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