What this study is
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).
What's being tested
- Intervention
Intervention · DEVICE
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 details
- 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
- Sponsor
- Ethicon, Inc.
- Conditions
- Stress Urinary Incontinence
- Enrolling
- 195 people
- Starts
- 2021-09-09
- Est. completion
- 2038-12-31
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 21 Years and overSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- Stress urinary incontinence symptoms
- Diagnostic evaluation, a positive cough stress rest, to confirm diagnosis of stress urinary incontinence.
- Female subjects ≥ 21 years of age requiring treatment of SUI
- Desired surgical correction of stress urinary incontinence using synthetic sub-urethral vaginal slings
- Planned surgery for primary stress incontinence without concomitant prolapse surgery
- Patient able and willing to participate in follow-up
- Subject or authorized representative has signed the approved informed consent
You can't join if
- 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
- Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of study product
- History of previous synthetic, biologic or fascial sub-urethral sling
- Pregnancy or plans for future pregnancy
- History of bleeding diathesis or current anti-coagulation therapy which cannot be suspended peri-operatively according to site's standard practice.
- Current genitourinary fistula or urethral diverticulum
- Reversible cause of incontinence (i.e. drug effect)
- Contraindication to surgery
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (4)
4 openInstitute for Female Pelvic Medicine
North Wales, Pennsylvania, United States
Recruiting
3 sites outside the US
Bio-Medical University Rome
Rome, Italy
RecruitingOspedale San Pietro Fatebenefratelli
Rome, Italy
RecruitingOspedale Regionale Beata Vergine
Mendrisio, Switzerland
Recruiting
Study team
Sponsor
Ethicon, Inc.
Study ID ESC_2020_04
Study director
Martin Weisberg, MD
Ethicon, Inc.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.