A Prospective Evaluation of a Prescription Digital Therapeutic for Treatment of Overactive Bladder in Women: The RiSolve Trial

"RiSolve is a Class I device in accordance with Rule 11 of Annex VIII of EU Medical Device Regulation (MDR) 2017/745. The RiSolve App is a smartphone application that users can download following a diagnosis of OAB by a healthcare provider, and following prescription of the RiSolve App. RiSolve consists of an 8-week program including activities to set baselines and assess progress, treatment modules, and modules to enhance engagement.~As part of setting baselines and assessing progress, participants complete a series of clinically validated questionnaires. This data is presented to users to promote self-monitoring of behaviours and a deeper understanding of their symptoms. A patient report is auto-generated at the end of treatment. This is sent to the patient and contains their in-app self-generated data, their questionnaire results and their bladder diary data (see Appendix 1: RiSolve Patient Report). This information is also provided to the prescribing healthcare provider as an object"