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. · 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).
Female subjects ≥ 21 years of age with a diagnosis of SUI, resulting from utrethral hypermobility and/or intrinsic sphincter deficiency.
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:
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.
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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Ethicon, Inc.