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APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women

RecruitingNAAges 22 Years - anyFemaleMedstar Health Research Institute
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • RiSolve App
  • AUGS Patient Handouts
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Where

10 sites
University of Alabama at Birmingham
Birmingham, United States
Stanford University
Palo Alto, United States
MedStar Health
Washington D.C., United States
University of Chicago
Chicago, United States
Curavit
Boston, United States
Atrium Health Wake Forest Baptist
Winston-Salem, United States
Allegheny Health
Pittsburgh, United States
Medical University of South Carolina Health
Charleston, United States

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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