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

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.…