MedTrace Logo

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

NCT04508153 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 369

Last updated 2021-12-09

No results posted yet for this 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

  • Stress Urinary Incontinence

Interventions

DEVICE

Leva Pelvic Digital Health System

Pelvic floor muscle training using the pelvic digital health system to treat pelvic floor disorders, specifically stress urinary incontinence.

OTHER

Kegel exercises

Pelvic floor muscle training (PFMT), commonly referred to as "Kegel" exercises, is a first line conservative treatment for pelvic floor disorders, specifically stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence (SMUI).

Sponsors & Collaborators

  • OBVIO HEALTH USA, Inc.

    collaborator UNKNOWN

  • University of Alabama at Birmingham

    collaborator OTHER

  • Renovia, Inc.

    lead INDUSTRY

Principal Investigators

  • Holly Richter, MD PhD · University of Alabama at Birmingham

  • Milena Weinstein, MD · Massachusetts General Hospital

  • Gena Dunnivan, MD · University of New Mexico

  • Noelani M Guaderrama, MD · Southern California Permanentae

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2021-04-23
Completion
2021-09-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04508153 on ClinicalTrials.gov