Comparing Use of a Digital Health System of Pelvic Floor Exercise Program

Status Completed

Clinical Trial Summary

Clinical Trial Description

A randomized controlled trial for patients with stress urinary incontinence or stress-dominant mixed incontinence.Subjects will be randomized to 8-weeks of home kegel exercises or 8 weeks of pelvic floor muscle exercises using the leva digital pelvic health system that includes visual biofeedback via smartphone. Leva subjects will perform guided pelvic floor muscle exercises for 2 1/2 minutes twice daily. Home kegel subjects will perform kegel exercises three times daily. Following 8-weeks of training, subjects will be permitted to continue the exercises or pursue additional therapies as indicated. Subjects randomized to the leva digital health system will be further randomized to receive automated reminders for the remainder of one year, or no additional reminders. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03632447
Study type	Interventional
Source	Renovia, Inc.
Contact
Status	Completed
Phase	N/A
Start date	October 24, 2018
Completion date	October 1, 2019

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Comparing Use of a Digital Health System of Pelvic Floor Exercise Program to Kegel Exercises in Stress Urinary Incontinence

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms