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APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Sponsor: Medstar Health Research Institute
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
Conditions
Interventions
RiSolve App
Participants randomized to intervention will be given access to the RiSolve PDTx app for 10 weeks after initial activation.
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