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Pelvic Floor Muscle Training With a Digital Therapeutic Device to Standard Exercises for Stress Urinary Incontinence
NCT04508153 · View on ClinicalTrials.gov ↗
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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 369 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Renovia, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04508153 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Alabama, California, New Mexico. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04508153?
The interventions under investigation include: Kegel exercises (OTHER), Leva Pelvic Digital Health System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04508153?
This trial is sponsored by Renovia, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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