Clinical trialNCT04508153CompletedInterventional

Pelvic Floor Muscle Training With a Digital Therapeutic Device to Standard Exercises for Stress Urinary Incontinence

SponsorRenovia, Inc.Enrollment369Stress Urinary Incontinence

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Gena Dunnivan, MD
University of New Mexico
Principal Investigator
clinicaltrials.gov ↗
Holly Richter, MD PhD
University of Alabama at Birmingham
Principal Investigator
clinicaltrials.gov ↗
Milena Weinstein, MD
Massachusetts General Hospital
Principal Investigator
clinicaltrials.gov ↗
Noelani M Guaderrama, MD
Southern California Permanentae
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

3 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Alabama *** Virtual Trial May Be Enrolled From Any Us Location
Birmingham, Alabama, United States
Southern California Permanente Medical Group*** Virtual Trial May Be Enrolled From Any Us Location
Irvine, California, United States
University of New Mexico *** Virtual Trial May Be Enrolled From Any Us Location
Albuquerque, New Mexico, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 1 Oct 2020
Primary completion: 23 Apr 2021
Completion: 1 Sept 2021
Last update posted: 9 Dec 2021
Registered enrollment: 369
Registry id: NCT04508153

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.