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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04508153
The ClinicalTrials.gov registry entry for NCT04508153 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 369 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 152-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target (143% higher). The listed sponsor is Renovia, which has 3 total studies on file at ClinicalTrials.gov.
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 3 study locations spanning 3 distinct geographic areas - top geographies include 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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Read our methodology - how this data is sourced, computed, and verified.
Related
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