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 the parent Phase II award are to determine the effectiveness of our system versus a sham control treatment in a home-use, pivotal clinical study. In the parent award, we are conducting a clinical study to identify a well-blinded sham control treatment (Specific Aim 1). We will also validate the treatment effectiveness and durability for mitigating urinary urge incontinence compared to the sham control in a pivotal trial (Specific Aim 2). In the Diversity Supplement, we have assigned TheraNova’s Software Engineer, Ms. Maitreyee Mittal, an engineering leadership role in the project. She will lead the software development efforts for the TranStim device in the pivotal clinical trial, which will be focused on mobile app development. The app will be used by participants to log urinary voiding data, the primary data collection means in the study and a critical component of the study’s success. Ms. Mittal will also oversee all device manufacturing efforts and assist with device troubleshooting. The proposed work for Ms. Mittal will be performed within the overall scope of the parent award.