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

NACompletedINTERVENTIONAL
Enrollment

369

Participants

Timeline

Start Date

October 1, 2020

Primary Completion Date

April 23, 2021

Study Completion Date

September 1, 2021

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)."

Trial Locations (3)

35233

University of Alabama *** Virtual Trial May be enrolled from any US Location, Birmingham

87112

University of New Mexico *** Virtual Trial May be enrolled from any US Location, Albuquerque

92618

Southern California Permanente Medical Group*** Virtual Trial May be enrolled from any US Location, Irvine

All Listed Sponsors
collaborator

OBVIO HEALTH USA, Inc.

UNKNOWN

collaborator

University of Alabama at Birmingham

OTHER

lead

Renovia, Inc.

INDUSTRY

NCT04508153 - Pelvic Floor Muscle Training With a Digital Therapeutic Device to Standard Exercises for Stress Urinary Incontinence | Biotech Hunter | Biotech Hunter