A Non-Invasive Neuromodulation Device for In-Home Treatment of Overactive Bladder

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Abstract Overactive bladder is a chronic and devastating condition in the aging population. Approximately 33 million people in the United States suffer from overactive bladder (OAB) and associated urinary urge incontinence (UUI), a chronic medical condition that drastically impairs quality of life and results in an annual economic burden of $66 billion. The psychological aspects of this chronic voiding dysfunction are particularly devastating; patients have increased incidences of depression, social isolation and sleep deprivation. Given that the incidence of OAB increases with advancing age, the prevalence of the condition and the total economic burden will continue to rise as the baby boomer population ages. Despite the high social and economic burden, a convenient, safe and effective treatment has yet to be realized. Recently, a minimally invasive neuromodulation device that provides percutaneous tibial nerve stimulation (PTNS) of the afferent sacral nerve, Congentix’s Urgent® PC, has shown clinical success; however, this device requires weekly in-clinic treatments as well as repeated placement of an electrode into the posterior tibial nerve, both of which are cost prohibitive and challenging for patient adherence. Implantable neurostimulators (RENOVA iStim and eCoin™) are also under development, but these devices require a surgical procedure and, accordingly, initial clinical studies have had high complication rates, with a second surgery often required to address these adverse events. To meet the need for a safe, effective, comfortable, and easy-to-use treatment for OAB, TheraNova has developed an inexpensive, convenient device that enables non-invasive tibial nerve stimulation at home. Previously, we demonstrated that subjects treated with this system achieved reductions in the mean number of voids, the mean number of voids with moderate to severe urgency, and the mean number of UUI events. The goals of this Phase II proposal are to determine the effectiveness of our system versus a sham control treatment in a home-use, pivotal clinical study. First, we will conduct a clinical study to identify a well-blinded sham control treatment (Specific Aim 1). Second, we will validate the treatment effectiveness and durability for mitigating urinary urge incontinence compared to the sham control in a pivotal trial (Specific Aim 2). The data obtained will support FDA 510(k) clearance and will allow us to commercialize the system within 3.5 years of the funding of this proposal.