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NCT04985799 · ClinicalTrials.gov registry record · NA
Comparing KIM to TVT Exact Sling
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 147
- Enrollment target
NCT04985799: Completed NA study, sponsored by University of North Carolina, Chapel Hill.
NCT04985799 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 147 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04985799, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 147 participants
- Enrollment target
Study Summary
To assess to the non-inferiority of the retropubic Neomedic Knotless Incontinence Mesh (KIM) sling compared to the Gynecare Tension-free Vaginal Tape (TVT) Exact sling. Participants: Women 21 years or older with a diagnosis of stress urinary incontinence (SUI) or mixed urinary incontinence (MUI) with objective evidence of SUI planning surgery for stress urinary incontinence. Procedures (methods): Patients will be randomized to receive either the Gynecare TVT Exact sling or the retropubic Neomedic KIM sling. Patients will be followed for 1 year postoperatively.
Primary Outcome
Treatment success is defined by a composite outcome of 1) response of No or "no bother" to question #3 on urogenital distress inventory-6 (UDI-6) validated questionnaire AND no retreatment of stress incontinence.
Interventions
- DEVICE Gynecare TVT Exact Continence System
- DEVICE Neomedic KIM (Knotless Incontinence Mesh)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 147 participants |
| Start Date | 2021-08-11 |
| Est. Completion | 2024-06-28 |
| Phase | NA |
What the finished NCT04985799 record still lists
NCT04985799 is an interventional study that assigns participants to a tested intervention. The registered 147 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Gynecare TVT Exact Continence System is the first listed.
NCT04985799 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04985799 about?
NCT04985799 is a clinical study titled "Comparing KIM to TVT Exact Sling". To assess to the non-inferiority of the retropubic Neomedic Knotless Incontinence Mesh (KIM) sling compared to the Gynecare Tension-free Vaginal Tape (TVT) Exact sling. Participants: Women 21 years or older with a diagnosis of stress urinary incontinence (SUI) or mixed urinary incontinence (MUI) wi...
What is the current status of trial NCT04985799?
This trial is currently completed. It is a NA study. The enrollment target is 147 participants. The study started on 2021-08-11. Estimated completion is 2024-06-28.
What interventions are being tested in trial NCT04985799?
The interventions under investigation include: Gynecare TVT Exact Continence System (DEVICE), Neomedic KIM (Knotless Incontinence Mesh) (DEVICE).
Who is sponsoring clinical trial NCT04985799?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04985799's enrollment target sits among peer trials
147 703rd of 2000 higher than 1,297 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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