Post Market Clinical Follow-up Study on TVT ABBREVO® 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 ABBREVO® Continence System in women undergoing 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) approximately 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 completion, approximately 10 yrs]
- 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:
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Stress urinary incontinence symptoms
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Diagnostic evaluation, a positive cough stress rest, to confirm diagnosis of stress urinary incontinence.
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Female subjects ≥ 21 years of age requiring treatment of SUI
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Desired surgical correction of stress urinary incontinence using synthetic sub-urethral vaginal slings
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Planned surgery for primary stress incontinence without concomitant prolapse surgery
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Patient able and willing to participate in follow-up
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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:
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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
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Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of study product
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History of previous synthetic, biologic or fascial sub-urethral sling
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Pregnancy or plans for future pregnancy
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History of bleeding diathesis or current anti-coagulation therapy which cannot be suspended peri-operatively according to site's standard practice.
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Current genitourinary fistula or urethral diverticulum
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Reversible cause of incontinence (i.e. drug effect)
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Contraindication to surgery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institute for Female Pelvic Medicine | North Wales | Pennsylvania | United States | 19454 |
| 2 | General University Hospital | Prague | Czechia | ||
| 3 | Bio-Medical University Rome | Rome | Italy | ||
| 4 | Zelazna Medical Center | Warsaw | Poland | ||
| 5 | Ospedale Regionale Beata Vergine | Mendrisio | Switzerland |
Sponsors and Collaborators
- Ethicon, Inc.
Investigators
- Study Director: Giovannie A Tommaselli, MD, Ethicon, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ESC_2020_04