APPROVE Trial Testing a Prescription Digital Therapeutic App for Treating Overactive Bladder in Adult Women

What this Trial Is About

Researchers are evaluating the effectiveness of a prescription digital therapeutic app called RiSolve compared to standard behavioral education through informational handouts for women with overactive bladder OAB. This trial focuses on women diagnosed with OAB, including symptoms like urinary urgency, urge urinary incontinence, urinary frequency, nocturia, and mixed incontinence with predominant OAB symptoms. The study aims to assess improvements in symptoms, quality of life, bladder function, patient satisfaction, and ongoing treatment effects. Participants are randomly assigned to one of two groups one group receives access to the RiSolve app for 10 weeks following activation, which offers behavioral therapy and cognitive behavioral therapy for OAB the other group receives standard behavioral education via patient handouts from the American Urogynecologic Society. After the initial 8 weeks, those in the control group may choose to switch to the RiSolve app treatment. The trial includes follow-up assessments at 6 and 12 months to monitor ongoing symptoms. During the study, participants will complete questionnaires such as the Overactive Bladder Questionnaire short-form OAB-q SF to measure symptom severity and quality of life, bladder diaries, and other validated tools to assess urinary symptoms and treatment satisfaction. Researchers will also track treatment adherence, accessibility, adverse events, and use of other therapies. The primary outcome is measured after 8 weeks, with continued symptom evaluation throughout the 12-month follow-up period to gather comprehensive data on treatment effects and patient experience.

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