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Recruiting Observational

Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System

NCT04829357 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2021-09-09
Last updated
2026-07-06

Condition(s) studied

Stress Urinary Incontinence

Investigational drug(s) / intervention(s)

Intervention

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.

Study 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).

Eligibility

Sex
FEMALE
Min age
21 Years
Max age
—
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. 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

Primary outcome measure(s)

  • 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

Trial sites (4)

FacilityCityRegionStatus
Institute for Female Pelvic Medicine North Wales Pennsylvania Recruiting
Bio-Medical University Rome Rome Italy Recruiting
Ospedale San Pietro Fatebenefratelli Rome Italy Recruiting
Ospedale Regionale Beata Vergine Mendrisio Switzerland Recruiting

More Ethicon, Inc. trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04829357 on ClinicalTrials.gov ↗ ← All trials in Italy