Stress Urinary Incontinence
Conditions
Keywords
GYNECARE TVT EXACT® Continence System, SUI
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).
Interventions
DEVICEIntervention
There is no intervention, beyond necessary clinical care, in this study. The surgical procedures being performed within the study are identical to the surgical procedures subjects would receive as part of SOC.
Sponsors
Ethicon, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Austria, Denmark, France, Germany, Sweden, United States
Contacts
STUDY_DIRECTORMartin Weisberg, MD
Ethicon, Inc.
Outcome results
None listed