APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Recruiting now · Not applicable
Conditions studied: Overactive Bladder (OAB), Urinary Urgency, Urinary Urge Incontinence (UUI), Nocturia, Urinary Frequency
In brief
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).
Key facts
- Study ID
- NCT06797245
- Run by
- Medstar Health Research Institute
- People needed
- 596
- Starts
- 2025-03-17
- Expected to finish
- 2028-07-01
- Last updated by the study team
- 2025-10-27
Who can join
Age: 22 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Wisconsin — Madison, Wisconsin, United States (enrolling)
- Stanford University — Palo Alto, California, United States (enrolling)
- MedStar Health — Washington D.C., District of Columbia, United States (enrolling)
- University of Chicago — Chicago, Illinois, United States (enrolling)
- University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
- Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States (enrolling)
- Allegheny Health — Pittsburgh, Pennsylvania, United States (enrolling)
- Medical University of South Carolina Health — Charleston, South Carolina, United States (enrolling)
- UT Southwestern Medical Center — Dallas, Texas, United States (enrolling)
- Curavit — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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