Post-Market Clinical Follow-Up onTVT EXACT® Continence System
Study Details
Study Description
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 Stress Urinary Incontinence (SUI).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Study Design
Outcome Measures
Primary Outcome Measures
- Cough Stress Test (CST) Assessment Change [Post-surgery through study completion, approximately 5-10 yrs]
Objective cure of Stress Urinary Incontinence (SUI) (treatment success) sproximately 5-10 years after surgery, defined as a negative CST
Secondary Outcome Measures
- Patient Global Impression of Improvement (PGI-I) [Post-surgery through study completion, approximately 10 yrs]
- International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) [Baseline and post-surgery through study completion, approximately 10 yrs]
- Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) [Baseline and post-surgery through study, approximately 10 yrs completion]
- Wong-Baker FACES® Pain Rating Scale [Post-surgery through study completion, approximately 10 yrs]
To assess pain on a scale from 0 (no pain) to 10 (worst pain) related to study device or procedure
Eligibility Criteria
Criteria
Inclusion Criteria:
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 Criteria:
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
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 | ||
5 | Herlev Hospital | Hillerod | Denmark | ||
6 | Hopital Jeanne de Flandres | Lille | France | ||
7 | Karolinska Institute | Stockholm | Sweden |
Sponsors and Collaborators
- Ethicon, Inc.
Investigators
- Study Director: Giovanni A Tommaselli, MD, Ethicon, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ESC_2020_05