Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System
NCT ID: NCT04829357
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
195 participants
OBSERVATIONAL
2021-09-09
2037-02-27
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Intervention
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 the subjects would receive as part of SOC.
Eligibility Criteria
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Inclusion Criteria
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
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
21 Years
FEMALE
No
Sponsors
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Ethicon, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Martin Weisberg, MD
Role: STUDY_DIRECTOR
Ethicon, Inc.
Locations
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Institute for Female Pelvic Medicine
North Wales, Pennsylvania, United States
Bio-Medical University Rome
Rome, , Italy
Ospedale San Pietro Fatebenefratelli
Rome, , Italy
Zelazna Medical Center
Warsaw, , Poland
Ospedale Regionale Beata Vergine
Mendrisio, , Switzerland
Countries
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Central Contacts
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Other Identifiers
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ESC_2020_04
Identifier Type: -
Identifier Source: org_study_id