Neural Modulation System for In-Home Treatment of Overactive Bladder

Abstract Overactive bladder is a chronic and devastating condition in the aging populationApproximatelymillion people in the United States suffer from overactive bladderOABand associated urge incontinenceUIa chronic medical condition that drastically impairs quality of life and results in an annual economic burden of $billionThe psychological aspects of this chronic voiding dysfunction are particularly devastatingpatients have increased incidences of depressionsocial isolation and sleep deprivationGiven that the incidence of UI increases with advancing agethe prevalence of the condition and the total economic burden will continue to rise as the baby boomer population agesDespite the high social and economic burdena convenientsafe and effective treatment has yet to be realizedRecentlya minimally invasive neuromodulation device that provides percutaneous posterior tibial nerve stimulationPTNSof the afferent sacral nerveCongentix s Urgent PChas shown clinical successhoweverthis device requires weekly in clinic treatments as well as repeated placement of an electrode into the posterior tibial nerveboth of which are cost prohibitive and challenging for patient adherenceTo address the need for a safeeffectivecomfortableand easy to use treatment for OABTheraNova has developed TranStimTMan inexpensiveconvenient device that enables a non invasivetranscutaneous PTNS for treatment of OABWe have designed TranStim with the following key innovationsProprietary electrical pulse sequence provides comfortable and supramaximal nerve stimulation without inducing tetanyDelivery of transcutaneous electrical stimulation through the plantar surface of the foot eliminates local pain and skin irritation induced by applied currentProper afferent nerve stimulation is monitored in real timeandEasy to use device that enables in home use with patient tailored therapyPreviouslywe have found that transcutaneous PTNS supplied by our TranStim prototype can achieve superior nerve stimulation compared to the commercially available percutaneous PTNS deviceUrgent PCin adult subjectsThe goals of this Phase I proposal are to identify a design that will maximize patient compliance and assess its efficacy in a pilot clinical studyFirstwe will evaluate three different TranStim electrode designs to maximize patient usability while providing tetany freesupramaximal stimulation of the posterior tibial nerve inelderly subjectsSpecific AimSecondwe will determine TranStim s effectiveness at mitigating urinary UI inelderly patients over anweek treatment protocolSpecific AimThe proof of principle data obtained through this proposal will demonstrate the therapeutic effect of non invasive PTNS treatment of UIThis data will also be used to support a Phase II submissionwhich will include a pivotalrandomizedsham controlled clinical study to rigorously demonstrate that TranStim is a safe and effective treatment for UI Narrative Overactive bladder is a chronic medical condition that significantly diminishes the quality of life for many elderly patientsCommercially available neurostimulation therapies for overactive bladder are efficacioushoweverthey are limited in clinical use due to their invasive and cumbersome natureWe propose a novelnoninvasiveperipheral nerve stimulation device for in home treatment of overactive bladder