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NCT04508153 · ClinicalTrials.gov registry record · NA
Pelvic Floor Muscle Training With a Digital Therapeutic Device to Standard Exercises for Stress Urinary Incontinence
A NA study of Stress Urinary Incontinence, sponsored by Renovia.
- Completed
- Registry status
- NA
- Development phase
- 369
- Enrollment target
- 3
- Study locations
NCT04508153: Completed NA study of Stress Urinary Incontinence, sponsored by Renovia.
NCT04508153 is a NA study of Stress Urinary Incontinence that has completed, run by Renovia. The registered enrollment target is 369 participants, above the 152-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target (143% higher). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04508153, a NA study of Stress Urinary Incontinence, has completed, sponsored by Renovia.
- COMPLETED
- Registry status
- NA
- Development phase
- 369 participants
- Enrollment target
- 3
- Study locations
Study Summary
A virtual prospective randomized controlled study to evaluate the efficacy of using the leva® Pelvic Digital Health System (PDHS) to perform PFMT compared to a standard home exercise home program for the treatment of SUI/SMUI. The treatment part of the study lasts eight weeks and has two arms. One group will receive routine care consisting of at-home Kegel exercises, and the other will be provided with a leva® device and instructions for use. Subjects in both groups will be assessed at baseline, then at 4 and 8 weeks for change and improvement of their symptoms. They will also be assessed at 6 and12 months after study completion.
Primary Outcome
UDI-6 is a validated questionnaire assessing symptom presence and degree of bother. It will be used to compare the degree of symptom change in the leva arm vs the Kegel arm within and between groups.
Conditions Studied
Interventions
- OTHER Kegel exercises
- DEVICE Leva Pelvic Digital Health System
Study Locations (3)
Alabama
- University of Alabama *** Virtual Trial May be enrolled from any US Location - Birmingham
California
- Southern California Permanente Medical Group*** Virtual Trial May be enrolled from any US Location - Irvine
New Mexico
- University of New Mexico *** Virtual Trial May be enrolled from any US Location - Albuquerque
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 369 participants |
| Start Date | 2020-10-01 |
| Est. Completion | 2021-09-01 |
| Phase | NA |
What the finished NCT04508153 record still lists
NCT04508153 is an interventional study that assigns participants to a tested intervention. The registered 369 participants enrollment target is mid-sized for trials with a published cap, above the 152-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target (143% higher).
The record links to 1 condition, with Stress Urinary Incontinence appearing as the primary indexed condition, and to 2 interventions - of which Kegel exercises is the first listed.
NCT04508153 reports a single indexed study location in Alabama, California, New Mexico.
Frequently Asked Questions
What is clinical trial NCT04508153 about?
NCT04508153 is a clinical study titled "Pelvic Floor Muscle Training With a Digital Therapeutic Device to Standard Exercises for Stress Urinary Incontinence". A virtual prospective randomized controlled study to evaluate the efficacy of using the leva® Pelvic Digital Health System (PDHS) to perform PFMT compared to a standard home exercise home program for the treatment of SUI/SMUI. The treatment part of the study lasts eight weeks and has two arms. One g...
What is the current status of trial NCT04508153?
This trial is currently completed. It is a NA study. The enrollment target is 369 participants. The study started on 2020-10-01. Estimated completion is 2021-09-01.
What conditions does trial NCT04508153 study?
This clinical trial studies the following conditions: Stress Urinary Incontinence.
What interventions are being tested in trial NCT04508153?
The interventions under investigation include: Kegel exercises (OTHER), Leva Pelvic Digital Health System (DEVICE).
Who is sponsoring clinical trial NCT04508153?
This trial is sponsored by Renovia, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04508153 being conducted?
This trial has 3 study locations across Alabama, California, New Mexico. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04508153's enrollment target sits among peer trials
369 4th of 35 higher than 32 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.
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