Status:
RECRUITING
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Lead Sponsor:
Medstar Health Research Institute
Collaborating Sponsors:
Foundation for Female Health Awareness (FFHA)
Conditions:
Overactive Bladder (OAB)
Urinary Urgency
Eligibility:
FEMALE
22+ years
Phase:
NA
Brief 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 t...
Detailed 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 grea...
Eligibility Criteria
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 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
Key Trial Info
Start Date :
March 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
596 Patients enrolled
Trial Details
Trial ID
NCT06797245
Start Date
March 17 2025
End Date
July 1 2028
Last Update
October 27 2025
Active Locations (10)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
2
Stanford University
Palo Alto, California, United States, 94304
3
MedStar Health
Washington D.C., District of Columbia, United States, 20010
4
University of Chicago
Chicago, Illinois, United States, 60637