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

NACompletedINTERVENTIONAL
Enrollment

77

Participants

Timeline

Start Date

October 24, 2018

Primary Completion Date

August 1, 2019

Study Completion Date

October 1, 2019

Conditions
Stress Urinary IncontinenceMixed Urinary Incontinence
Interventions
DEVICE

Leva

Subjects randomized to Leva will use a vaginal probe containing motion-based sensors to direct the performance of pelvic muscle exercises.

DEVICE

PFDx

All subjects (in both study arms) will be evaluated using a vaginally placed device that will evaluate pelvic floor motion to document change in pelvic floor muscle function resulting from pelvic floor muscle exercises.

Trial Locations (7)

35233

University of Alabama, Birmingham

44195

Cleveland Clinic, Cleveland

60611

Northwestern University, Chicago

73104

Univeristy of Oklahoma, Oklahoma City

78229

Urology San Antonio, San Antonio

90211

Cedars-Sinai Medical Group, Beverly Hills

02114

Massachusetts General Hospital, Boston

All Listed Sponsors
lead

Renovia, Inc.

INDUSTRY

NCT03632447 - Comparing Use of a Digital Health System of Pelvic Floor Exercise Program to Kegel Exercises in Stress Urinary Incontinence | Biotech Hunter | Biotech Hunter