Overactive Bladder Study

Objective

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.

Methodology

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.