An observational study in Stress Urinary Incontinence, sponsored by Ethicon, Inc.. Active, not recruiting at 8 sites in 6 countries. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Ethicon, Inc. (part of Johnson & Johnson) · Observational
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).
651 studies on the registry are indexed under Urinary Incontinence, Stress; 120 are open to participants now.
This study's enrollment of 198 is above the median of 130 across 127 observational studies indexed under Urinary Incontinence, Stress.
Browse Urinary Incontinence, Stress studies →Ethicon, Inc. is the lead sponsor of 66 studies on the registry; 2 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Female subjects ≥ 21 years of age with a diagnosis of SUI, resulting from utrethral hypermobility and/or intrinsic sphincter deficiency.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study:
Exclusion Criteria:
Subjects meeting any of the following criteria will be considered not eligible for enrollment in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
Time frame: Post-surgery through study completion, approximately 5-10 yrs
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
To assess pain on a scale from 0 (no pain) to 10 (worst pain) related to study device or procedure
Time frame: Post-surgery through study completion, approximately 10 yrs
Plan to share: 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.
Data sharing details ↗ · yoda.yale.edu
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Urinary Incontinence, Stress →