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RECRUITING
NCT06797245
NA

APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women

Sponsor: Medstar Health Research Institute

View on ClinicalTrials.gov

Summary

The APPROVE trial is a multi-centered, randomized controlled trial designed to assess differences in symptom improvement, quality of life, bladder symptoms, satisfaction with treatment and continued treatment efficacy in women with overactive bladder (OAB) randomized to a prescription digital therapeutic (PDTx) app called RiSolve compared to standard behavioral education (handouts).

Official title: The APPROVE Trial: A Randomized Controlled Trial Evaluating the Efficacy and Safety of a Prescription Digital Therapeutic for Treatment of Overactive Bladder in Women

Key Details

Gender

FEMALE

Age Range

22 Years - Any

Study Type

INTERVENTIONAL

Enrollment

596

Start Date

2025-03-17

Completion Date

2028-07

Last Updated

2025-10-27

Healthy Volunteers

No

Interventions

DEVICE

RiSolve App

Participants randomized to intervention will be given access to the RiSolve PDTx app for 10 weeks after initial activation.

BEHAVIORAL

AUGS Patient Handouts

AUGS "Overactive Bladder" and "Pelvic Floor Muscles and Bladder Training" Patient Fact Sheets will be provided and reviewed.

Locations (10)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Stanford University

Palo Alto, California, United States

MedStar Health

Washington D.C., District of Columbia, United States

University of Chicago

Chicago, Illinois, United States

Curavit

Boston, Massachusetts, United States

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

Allegheny Health

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina Health

Charleston, South Carolina, United States

UT Southwestern Medical Center

Dallas, Texas, United States

University of Wisconsin

Madison, Wisconsin, United States