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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 is a NA study that has completed, run by Renovia. The registered enrollment target is 23 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03536923
The ClinicalTrials.gov registry entry for NCT03536923 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Renovia, which has 3 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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