Actively Recruiting
Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System
Led by Ethicon, Inc. · Updated on 2026-05-08
195
Participants Needed
4
Research Sites
903 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female subjects aged 21 years or older
- Symptoms of stress urinary incontinence
- Positive cough stress test confirming stress urinary incontinence
- Planned surgical correction of stress urinary incontinence using synthetic sub-urethral vaginal slings
- Surgery planned for primary stress urinary incontinence without prolapse surgery
- Able and willing to participate in follow-up visits
- Signed informed consent or authorized representative consent
You will not qualify if you...
- Physical or psychological conditions impairing participation or unwillingness to attend all study visits and complete questionnaires
- Pre-operative or intra-operative findings preventing use of study product
- History of previous synthetic, biologic, or fascial sub-urethral sling surgery
- Pregnancy or plans for future pregnancy
- History of bleeding disorders or current anti-coagulation therapy that cannot be stopped peri-operatively
- Current genitourinary fistula or urethral diverticulum
- Reversible cause of incontinence such as drug effects
- Contraindications to surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Institute for Female Pelvic Medicine
North Wales, Pennsylvania, United States, 19454
Actively Recruiting
2
Bio-Medical University Rome
Rome, Italy
Actively Recruiting
3
Ospedale San Pietro Fatebenefratelli
Rome, Italy
Actively Recruiting
4
Ospedale Regionale Beata Vergine
Mendrisio, Switzerland
Actively Recruiting
Research Team
C
Christine Romanowski
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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