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

这个小型企业创新研究(SBIR)第一阶段项目的更广泛的影响/商业潜力是加速开发一种新型的非手术医疗设备和治疗方法，用于大约三分之一的30岁以上患有尿失禁的女性，其中三分之二的人，部分由于现有解决方案的显著缺陷，选择在症状逐渐恶化的情况下不接受治疗。尿失禁，虽然是一个非常私人的问题，但具有深远的生理、心理、社会和经济影响。例如，尿失禁被发现与抑郁症一样降低了与健康相关的生活质量指标，失禁是进入疗养院的首要原因，美国医疗体系每年的成本估计为250亿美元。通过设计和验证活动，该项目将展示一种可穿戴设备的功能，为女性压力性尿失禁提供谨慎、舒适、易于使用的治疗方法。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，该产品将改善数千万美国女性的生活。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治疗大小便失禁，而不会中断日常活动。目前的非手术治疗通常包括通过阴道探头进行电刺激，这是大多数女性不愿意采用或维持的治疗方法。该项目的目标是展示放置在会阴组织附近的连续的皮肤电极阵列的能力，以提供足够的肌肉电刺激来促进盆底调理，并进一步在与持续佩戴相关的条件下保持这一功效。在成功的概念原型验证的基础上，将使用台式模型开发、制造和验证多个候选设计。测试将探索在患者活动期间保持电极？]皮肤接触和有效管理体液(即渗漏)方面的挑战。在整个项目中，将使用越来越复杂的模型，最后对人体身体组织进行评估。该项目预计将确定一种适合于未来人类临床研究、FDA批准和产品商业化评估的首选候选电极设计。

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.