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
Medstar Health Research Institute
596 participants
Mar 17, 2025
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
Inclusion Criteria5
- 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 Criteria14
- 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 the past two weeks
- Currently using intermittent or indwelling catheter
- History of bladder/urethral, colon/anal, or cervical cancer
- Current or prior use of sacral neuromodulation, tibial stimulation or onabotulinum toxin type A intradetrusor injection
- Currently taking antibiotics/drugs for urinary tract infection\^
- Currently undergoing or unwilling to forego pelvic floor physical therapy with a physical therapist or prescription device for the 8-week intervention period
- Planning surgery for pelvic organ prolapse within 12 months of randomization
- Pelvic surgery within the past 6 months
- Planning to undergo pessary fitting °
- Those on antibiotics for urinary tract infection will be eligible for enrollment 2 weeks after completing antibiotic therapy with subjective resolution of UTI symptoms °Will be eligible after completing pessary fitting
- https://researchdata.medstar.net/redcap/surveys/?s=MM7WN7EXACX4PNXJ
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Interventions
Participants randomized to intervention will be given access to the RiSolve PDTx app for 10 weeks after initial activation.
AUGS "Overactive Bladder" and "Pelvic Floor Muscles and Bladder Training" Patient Fact Sheets will be provided and reviewed.
Locations(10)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06797245