SBIR Phase I: Design and validation of a novel skin-contacting electrode to provide pelvic floor toning for treatment of female stress urinary incontinence

这个小企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力是加速一种新型非？外科医疗设备和治疗对大约三分之一患有尿失禁的30岁以上妇女的治疗，其中三分之二的人，部分由于明显缺乏可用的解决办法，在症状逐渐恶化的情况下选择不接受治疗。尿失禁，虽然是一个非常私人的问题，但迄今为止？对身体、心理、社会和经济的影响。例如，尿失禁已经被发现与抑郁症一样会降低与健康相关的生活质量，尿失禁是进入养老院的第一大原因，美国医疗保健系统每年的成本估计为250亿美元。通过设计和验证活动，该项目将展示可穿戴设备的功能，该设备提供谨慎，舒适，易于使用的功能。使用治疗女性压力性尿失禁。通过这项工作获得的技术理解为随后开发一种商业上可行的、FDA批准的产品奠定了基础，这将改善数千万美国妇女的生活。拟议的项目为可穿戴疗法提供了一个新的框架，使患者能够通过谨慎的表面电刺激来治疗尿失禁，而不会中断日常活动。目前非?外科治疗通常包括通过阴道内探针进行电刺激，这是大多数女性不愿意采用或维持的治疗方法。该项目的目标是证明在会阴组织附近放置连续的皮肤电极阵列的能力，以提供足够的电肌肉刺激来促进盆底调节，并进一步在持续磨损的情况下保持这种功效。建立在一个成功的证明之上？概念原型，多个候选设计将开发，制造和验证使用台式模型。测试将探索维护电极的挑战。患者活动期间的皮肤接触和体液（即渗漏）的有效管理。在整个项目中，将使用越来越复杂的模型，最后对人体尸体组织进行评估。该项目预计将确定一种首选的候选电极设计，适合未来在人体临床研究、FDA批准和产品商业化中的评估。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is the expedited development of a novel non?]surgical medical device and therapeutic treatment for the approximately 1 in 3 women over the age of 30 who suffer from urinary incontinence, two thirds of whom, in part due to notable deficiencies of available solutions, elect to live without treatment while their symptoms progressively worsen. Urinary incontinence, although a very private concern, has far?]reaching physical, psychological, social, and economic implications. For example, urinary incontinence has been found to reduce health-related quality of life measures on par with depression, incontinence is the number one reason for admittance into nursing homes, and the annual cost to the US healthcare system is estimated at $25 billion. Through design and validation activities this project will demonstrate the functionality of a wearable device that provides discreet, comfortable, easy?]to?]use therapy for female stress urinary incontinence. The technological understanding gained through this work lays the groundwork for subsequent development of a commercially viable, FDA cleared product that will enhance the lives of tens of millions of American women.The proposed project provides a new framework for wearable therapeutics by enabling the patient to treat incontinence via discreet surface electrical stimulation without interruption to daily activity. Current non?]surgical care often involves electrical stimulation via intravaginal probe, a treatment most woman are not willing to adopt or maintain. The goal of this project is to demonstrate the ability of a contiguous array of cutaneous electrodes placed proximate the perineal tissue to deliver sufficient electrical muscle stimulation to promote pelvic floor toning, and further to maintain this efficacy under conditions associated with continuous wear. Building on a successful proof?]of?]concept prototype, multiple candidate designs will be developed, fabricated and validated using benchtop models. Testing will explore challenges with maintaining electrode?]skin contact during patient mobility and effective management of bodily fluids (i.e. leakage). Throughout the project, increasingly complex models will be utilized, concluding with assessment in human cadaveric tissue. The project is expected to identify a preferred candidate electrode design suitable for future evaluation in a human clinical study, FDA clearance and product commercialization.