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

摘要 在老龄化人口中，膀胱过度活动是一种慢性和破坏性的疾病。大约3300万 美国人患有膀胱过度活动症(OAB)和相关的尿急失禁(UUI)， 一种慢性疾病，严重损害生活质量，并导致每年 660亿美元。这种慢性排尿障碍的心理方面尤其具有破坏性；患者 增加了抑郁、社会孤立和睡眠剥夺的发生率。鉴于OAB的发病率 随着年龄的增长，该病的患病率和总的经济负担将继续增加 随着婴儿潮一代人口的老龄化，这一比例也在上升。尽管社会和经济负担沉重，但方便、安全和 有效的治疗方法尚未实现。最近，一种微创神经调节设备提供了 经皮胫神经刺激(PTNS)传入骶神经，Congentix的URGRENT®PC已显示 临床成功；然而，这种装置需要每周的临床治疗以及重复放置一个 将电极插入胫后神经，这两种方法的成本都很高，而且对患者的依从性具有挑战性。 植入式神经刺激器(Renova iStim和eCoin™)也在开发中，但这些设备 需要外科手术，因此，最初的临床研究有很高的并发症发生率， 经常需要二次手术来解决这些不良事件。以满足对安全、有效、 对于OAB，TheraNova开发了一种廉价、方便的治疗方法 这使得在家里进行非侵入性的胫神经刺激成为可能。之前，我们证明了受试者接受了 通过该系统实现了平均空隙数的减少，具有中等到 严重的紧迫性，以及UUI事件的平均数量。母公司第二阶段奖的目标是确定 在一项家庭使用的关键临床研究中，我们的系统与假对照治疗的有效性。在 家长奖，我们正在进行一项临床研究，以确定良好的盲法假对照治疗(特定目的 1)。我们还将验证治疗对缓解急迫性尿失禁的有效性和持久性。 与关键试验中的假对照(特定目标2)进行比较。在多样性副刊中，我们已经分配了 TheraNova的软件工程师Maitreyee Mittal女士在该项目中担任工程领导角色。她会的 在关键的临床试验中领导TranSTim设备的软件开发工作，这将是重点 关于移动应用程序的开发。参与者将使用这款应用程序来记录尿液排尿数据，这是主要数据 收集意味着在研究中，也是研究成功的关键组成部分。米塔尔女士还将监督所有 负责设备制造工作并协助设备故障排除。米塔尔女士的拟议工作将是 在父奖项的总体范围内执行。

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.