The APPROVE Trial: A Randomized Controlled Trial Evaluating the Efficacy and Safety of a Prescription Digital Therapeutic for Treatment of Overactive Bladder in Women
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).
Description
In this trial, we will employ a randomized controlled trial design to determine if women with overactive bladder (OAB) treated with the RiSolve prescription digital therapeutic (PDTx) demonstrate greater improvement in OAB-related health as compared to standard behavioral education with informational handouts. RiSolve is a digital therapeutic device intended to provide behavioral therapy and cognitive behavioral therapy (CBT) for adult women who have been diagnosed with OAB, which includes urinary urgency with or without urge urinary incontinence (UUI), urinary frequency, nocturia, and mixed i…
Eligibility
- Age range
- 22+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Women ≥ 22 years old * Bothersome OAB symptoms (defined as bother rating ≥ 5 on ICIQ-FLUTS question #3b or #9b) * English-speaking * Willing to forego other treatment outside of medications for the 8-week trial period * Use of at least one mobile App Exclusion Criteria: * Stress-predominant mixed urinary incontinence (defined as QUID stress score \> QUID urge score) * Voiding dysfunction defined as response ≥ 2 on ICIQ-FLUTS question #7a * Bladder pain defined as response ≥ 2 on ICIQ-FLUTS question #4a * Use of an OAB medication (anticholinergic or beta-agonist) within…
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 BirminghamBirmingham, Alabama
- Stanford UniversityPalo Alto, California
- MedStar HealthWashington D.C., District of Columbia
- University of ChicagoChicago, Illinois
- CuravitBoston, Massachusetts
- Atrium Health Wake Forest BaptistWinston-Salem, North Carolina