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NCT03536923 · ClinicalTrials.gov registry record · NA
Use of the Leva Incontinence System in Treating Bladder Incontinence.
A NA study, sponsored by Renovia.
- Completed
- Registry status
- NA
- Development phase
- 23
- Enrollment target
NCT03536923: Completed NA study, sponsored by Renovia.
NCT03536923 is a NA study that has completed, run by Renovia. The registered enrollment target is 23 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03536923, a NA study, has completed, sponsored by Renovia.
- COMPLETED
- Registry status
- NA
- Development phase
- 23 participants
- Enrollment target
Study Summary
This open-label proof-of-concept study is designed to evaluate the impact of the leva digital incontinence system on the treatment of stress and mixed urinary incontinence in women over a six week period. Subjects will participate in a 2.5 minute exercise program twice daily (performed at a clinic with therapist assistance 5x weekly, and at home once daily on weekdays and twice daily on weekends. Validated surveys (UDI-6, IIQ-7 and PGI-I) will be used to evaluate symptom relief. A battery of pelvic floor muscle exercises will be performed weekly to evaluate progress in muscle strengthening.
Primary Outcome
A validated, standardized questionnaire (the short form of the urogenital distress inventory, UDI-6) will be used to evaluate change in symptoms of urinary incontinence. Minimum score = 0, Maximum score = 100, lower scores indicate fewer symptoms.
Interventions
- DEVICE Leva Incontinence System For Pelvic Floor Muscle strengthening
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2017-04-10 |
| Est. Completion | 2017-10-20 |
| Phase | NA |
What the finished NCT03536923 record still lists
NCT03536923 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Leva Incontinence System For Pelvic Floor Muscle strengthening is the first listed.
NCT03536923 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03536923 about?
NCT03536923 is a clinical study titled "Use of the Leva Incontinence System in Treating Bladder Incontinence.". This open-label proof-of-concept study is designed to evaluate the impact of the leva digital incontinence system on the treatment of stress and mixed urinary incontinence in women over a six week period. Subjects will participate in a 2.5 minute exercise program twice daily (performed at a clinic w...
What is the current status of trial NCT03536923?
This trial is currently completed. It is a NA study. The enrollment target is 23 participants. The study started on 2017-04-10. Estimated completion is 2017-10-20.
What interventions are being tested in trial NCT03536923?
The interventions under investigation include: Leva Incontinence System For Pelvic Floor Muscle strengthening (DEVICE).
Who is sponsoring clinical trial NCT03536923?
This trial is sponsored by Renovia, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03536923's enrollment target sits among peer trials
23 1755th of 2000 higher than 245 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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