To evaluate the safety and efficacy of a novel medical device for the treatment of OAB, and test multiple versions of the device's companion app to determine how to best drive compliance to maximize device efficacy.
This is a 52-week at-home, randomized, active control study comparing the device to the current Rx standard of care. Patients will complete screening/enrollment during a home visit from a study nurse.
Over the duration of the study, the ObvioHealth app collects efficacy and safety data that the COACH team will monitor in real-time and proactively address to mitigate safety & compliance concerns.
FDA submission will include valuable data substantiating that the device + companion app is capable of delivering real-world results superior to Rx alone.
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