Stress Urinary Incontinence Clinical Trial
Official title:
A Long Term Prospective Post Market Clinical Follow-up (PMCF) of the GYNECARE TVT ABBREVO® Continence System for the Treatment of Stress Urinary Incontinence
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).
Status | Recruiting |
Enrollment | 195 |
Est. completion date | February 27, 2036 |
Est. primary completion date | September 30, 2035 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 21 Years and older |
Eligibility | 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. Diagnostic evaluation, a positive cough stress rest, to confirm diagnosis of stress urinary incontinence. 3. Female subjects = 21 years of age requiring treatment of SUI 4. Desired surgical correction of stress urinary incontinence using synthetic sub-urethral vaginal slings 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 sub-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 |
Country | Name | City | State |
---|---|---|---|
Italy | Bio-Medical University Rome | Rome | |
Italy | Ospedale San Pietro Fatebenefratelli | Rome | |
Poland | Zelazna Medical Center | Warsaw | |
Switzerland | Ospedale Regionale Beata Vergine | Mendrisio | |
United States | Institute for Female Pelvic Medicine | North Wales | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Ethicon, Inc. |
United States, Italy, Poland, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cough Stress Test (CST) Assessment Change | Objective cure of Stress Urinary Incontinence (SUI) (treatment success) approximately 5-10 years after surgery, defined as a negative CST | Post-surgery through study completion, approximately 5-10 yrs | |
Secondary | Patient Global Impression of Improvement (PGI-I) | Post-surgery through study completion, approximately 10 yrs | ||
Secondary | International Consultation on Incontinence Questionnaire- Urinary Incontinence Short Form (ICIQ-UI SF) | Baseline and post-surgery through study completion, approximately 10 yrs | ||
Secondary | Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) | Baseline and post-surgery through study completion, approximately 10 yrs | ||
Secondary | Wong-Baker FACES® Pain Rating Scale | To assess pain on a scale from 0 (no pain) to 10 (worst pain) related to study device or procedure. | Post-surgery through study completion, approximately 10 yrs |
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