Stress Urinary IncontinenceNCT04829994
Post-Market Clinical Follow-Up onTVT EXACT® Continence System
An observational study of Stress Urinary Incontinence, run by Ethicon, Inc. at 8 sites in 6 countries.
Trial summary
The objective of this single arm, post market, clinical study is to evaluate the performance of Gynecare TVT EXACT® Continence System in women undergoing retropubic 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
- 198 participants
- Where
- 8 sitesin 6 countries
- Study dates
- 7 Jul 2021to 30 Sep 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 utrethral 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
- Stress urinary incontinence confirmed by diagnostic evaluation of a cough stress test
- Female subjects ≥ 21 years of age requiring treatment of SUI
- Desired surgical correction of stress urinary incontinence using a synthetic pubo-urethral vaginal sling
- 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 pubo-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.
Show all 9Show fewer
- Current genitourinary fistula or urethral diverticulum
- Reversible cause of incontinence (i.e. drug effect)
- Contraindication to surgery
Trial locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
United States3 sites
Duke University
Durham, North Carolina, 27707
Institute for Female Pelvic Medicine
North Wales, Pennsylvania, 19454
UPMC
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Long Term Prospective Post Market Clinical Follow-up (PMCF) of the GYNECARE TVT EXACT® 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 EXACT® Continence System in women undergoing retropubic mid-urethral sling surgery for Stress Urinary Incontinence (SUI).
- Conditions
- Stress Urinary Incontinence
- Being tested
- Intervention
- Keywords
- GYNECARE TVT EXACT® 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 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) sproximately 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, approximately 10 yrs completion
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 start7 Jul 2021
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Sep 2035 (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
- 198 participants (actual)
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
- NCT04829994
- Sponsor's protocol ID
- ESC_2020_05
- Status last verified
- Jul 2026
- First submitted
- 17 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long Term Prospective Post Market Clinical Follow-up (PMCF) of the GYNECARE TVT EXACT® Continence System for the Treatment of Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT04829994
- Acronym / sponsor ID
- ESC_2020_05
- Conditions
- Stress Urinary Incontinence
- Keywords
- GYNECARE TVT EXACT® Continence System, SUI
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 30 Sep 2035 (estimated)
- First posted
- 2 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this single arm, post market, clinical study is to evaluate the performance of Gynecare TVT EXACT® Continence System in women undergoing retropubic mid-urethral sling surgery for Stress Urinary Incontinence (SUI).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female subjects ≥ 21 years of age with a diagnosis of SUI, resulting from utrethral hypermobility and/or intrinsic sphincter deficiency.
Key inclusion criteria (8 listed)
- Subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study:
- Stress urinary incontinence symptoms
- Stress urinary incontinence confirmed by diagnostic evaluation of a cough stress test
- Female subjects ≥ 21 years of age requiring treatment of SUI
- Desired surgical correction of stress urinary incontinence using a synthetic pubo-urethral vaginal sling
Key exclusion criteria (9 listed)
- 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 pubo-urethral sling
- Pregnancy or plans for future pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionThere is no intervention, beyond necessary clinical care, in this study. The surgical procedures being performed within the study are identical to the surgical procedures subjects would receive as part of SOC. | Device | – |
Primary outcome
Cough Stress Test (CST) Assessment Change
Time frame: Post-surgery through study completion, approximately 5-10 yrs
Objective cure of Stress Urinary Incontinence (SUI) (treatment success) sproximately 5-10 years after surgery, defined as a negative CST
4 secondary outcomes
Patient Global Impression of Improvement (PGI-I)
Time frame: Post-surgery through study completion, approximately 10 yrs
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
Time frame: Baseline and post-surgery through study completion, approximately 10 yrs
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
Time frame: Baseline and post-surgery through study, approximately 10 yrs completion
Wong-Baker FACES® Pain Rating Scale
Time frame: Post-surgery through study completion, approximately 10 yrs
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Weisberg, MD study director
Ethicon, Inc.
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Urinary Incontinence, run by Ethicon, Inc. at 8 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Austria, Denmark, France, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cough Stress Test (CST) Assessment Change (time frame: Post-surgery through study completion, approximately 5-10 yrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.