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NCT04829994 · ClinicalTrials.gov registry record
Post-Market Clinical Follow-Up onTVT EXACT® Continence System
A clinical trial of Stress Urinary Incontinence, sponsored by Ethicon.
- Active
- Registry status
- 198
- Enrollment target
- 8
- Study locations
NCT04829994: Active study of Stress Urinary Incontinence, sponsored by Ethicon.
NCT04829994 is a study of Stress Urinary Incontinence that is active but no longer recruiting, run by Ethicon. The registered enrollment target is 198 participants, above the 157-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target (26% higher). The trial reports 8 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04829994, a study of Stress Urinary Incontinence, is active but no longer recruiting, sponsored by Ethicon.
- ACTIVE NOT RECRUITING
- Registry status
- 198 participants
- Enrollment target
- 8
- Study locations
Study 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).
Primary Outcome
Objective cure of Stress Urinary Incontinence (SUI) (treatment success) sproximately 5-10 years after surgery, defined as a negative CST
Conditions Studied
Interventions
- DEVICE Intervention
Study Locations (8)
Other
- Ordensklinikum Linz - Linz
- Herlev Hospital - Hillerød
- Hopital Jeanne de Flandres - Lille
- Universitatsklinikum Tubingen - Tübingen
- Karolinska Institute - Stockholm
Pennsylvania
- Institute for Female Pelvic Medicine - North Wales
- UPMC - Pittsburgh
North Carolina
- Duke University - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 198 participants |
| Start Date | 2021-07-07 |
| Est. Completion | 2035-09-30 |
What the registry record for NCT04829994 still lists
NCT04829994 is an observational study that tracks outcomes without assigning an intervention. The registered 198 participants enrollment target is mid-sized for trials with a published cap, above the 157-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target (26% higher).
The record links to 1 condition, with Stress Urinary Incontinence appearing as the primary indexed condition, and to 1 intervention - of which Intervention is the first listed.
NCT04829994 lists 8 locations in 3 states (Other, Pennsylvania, North Carolina).
Frequently Asked Questions
What is clinical trial NCT04829994 about?
NCT04829994 is a clinical study titled "Post-Market Clinical Follow-Up onTVT EXACT® Continence System". 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).
What is the current status of trial NCT04829994?
This trial is currently active not recruiting. The enrollment target is 198 participants. The study started on 2021-07-07. Estimated completion is 2035-09-30.
What conditions does trial NCT04829994 study?
This clinical trial studies the following conditions: Stress Urinary Incontinence.
What interventions are being tested in trial NCT04829994?
The interventions under investigation include: Intervention (DEVICE).
Who is sponsoring clinical trial NCT04829994?
This trial is sponsored by Ethicon, which has 38 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04829994 being conducted?
This trial has 8 study locations across North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stress Urinary Incontinence
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04829994's enrollment target sits among peer trials
198 7th of 35 higher than 29 of 35 other Stress Urinary Incontinence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stress Urinary Incontinence trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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ProACT Post-Approval Study
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Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence
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Comparison of Virtual Pelvic Floor Physical Therapy With a Pelvic Floor Trainer in the Treatment of Stress Urinary Incontinence.
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Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry
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