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).
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
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
Medstar Health Research Institute
Lead sponsor
Foundation for Female Health Awareness (FFHA)
Collaborator