RecruitingNot ApplicableNCT06797245

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

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


Sponsor

Medstar Health Research Institute

Enrollment

596 participants

Start Date

Mar 17, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Sex: FEMALEMin Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called AUGS Patient Handouts and a medical device called RiSolve App for people with nocturia, overactive bladder (oab), and other related conditions. The study is currently recruiting participants at 10 locations. People eligible for this study include women aged 22 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERiSolve App

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

BEHAVIORALAUGS 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

View Full Details on ClinicalTrials.gov

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NCT06797245


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