Stress Urinary IncontinenceNCT04829357
Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System
An observational study of Stress Urinary Incontinence, run by Ethicon, Inc. at 4 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Intervention
- Type of treatment
- Medical device
- How many people
- 195 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 9 Sep 2021to 31 Dec 2038
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female subjects ≥ 21 years of age with a diagnosis of SUI, resulting from urethral hypermobility and/or intrinsic sphincter deficiency
Who may be able to join
- Subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study:
- 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
Who cannot join
- Subjects meeting any of the following criteria will be considered not eligible for enrollment in this study:
- 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.
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- Current genitourinary fistula or urethral diverticulum
- Reversible cause of incontinence (i.e. drug effect)
- Contraindication to surgery
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
Italy2 sites, 2 recruiting
- Recruiting
Bio-Medical University Rome
Rome
- Recruiting
Ospedale San Pietro Fatebenefratelli
Rome
United States1 site, 1 recruiting
- Recruiting
Institute for Female Pelvic Medicine
North Wales, Pennsylvania, 19454
Switzerland1 site, 1 recruiting
- Recruiting
Ospedale Regionale Beata Vergine
Mendrisio
About this study
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
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
- Stress Urinary Incontinence
- Being tested
- Intervention
- Keywords
- Gynecare TVT ABBREVO® Continence System, SUI
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough Stress Test (CST) Assessment Change
Objective cure of Stress Urinary Incontinence (SUI) (treatment success) approximately 5-10 years after surgery, defined as a negative CST
Measured: Post-surgery through study completion, approximately 5-10 yrs
Secondary outcomes (4)
Patient Global Impression of Improvement (PGI-I)
Measured: Post-surgery through study completion, approximately 10 yrs
International Consultation on Incontinence Questionnaire- Urinary Incontinence Short Form (ICIQ-UI SF)
Measured: Baseline and post-surgery through study completion, approximately 10 yrs
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
Measured: Baseline and post-surgery through study completion, approximately 10 yrs
Wong-Baker FACES® Pain Rating Scale
To assess pain on a scale from 0 (no pain) to 10 (worst pain) related to study device or procedure.
Measured: Post-surgery through study completion, approximately 10 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start9 Sep 2021
- Primary completion31 Dec 2033 (estimated)
- Study completion31 Dec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Weisberg, MD, Study director, Ethicon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829357
- Sponsor's protocol ID
- ESC_2020_04
- Status last verified
- Jul 2026
- First submitted
- 12 Mar 2021
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.