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The Vivally® System is a wearable neuromodulation system to treat patients with the bladder conditions of urge urinary incontinence and urinary urgency.

The Vivally System is a wearable, non-invasive, bladder control therapy with a mobile application to treat patients with the conditions of urge urinary incontinence and urinary urgency, without the need for surgery, implants, drugs, or needle-electrodes. The Vivally System utilizes neuromodulation to deliver electrical signals to the tibial nerve. The tibial nerve is a mixed (motor and sensory) peripheral nerve that feeds into the sacral plexus which contains the nerves that innervate the detrusor muscle surrounding the urinary bladder. The Vivally System also includes an analog input that measures the electromyogram (EMG) signal from the patient's foot via three additional EMG electrodes embedded on the Garment. The system operates in a combination of closed-loop using EMG as the physiological feedback, as well as in open-loop when the feedback signal is unreliable or unreadable. The main components of the Vivally System include a rechargeable-controller (Stimulator) powered by a rechargeable lithium-ion battery, an ankle worn Garment designed to be used on the left or right ankle, Gel Cushions and charging accessories. The Vivally System also includes a mobile application on the patient's personal device and a HIPAAcompliant cloud database. The Vivally Mobile Application allows the patient to start and manage a therapy session and provides access to condition support tools such as an electronic bladder diary to record symptoms, fluid intake and other factors impacting their condition and a record of therapy compliance. The HIPAA-compliant Vivally Cloud Database collects patient therapy statistics, therapy compliance and symptom tracking over time and can be accessed by the patient and physician as a tool to monitor and manage treatment.