SBIR Phase II: Novel Treatment for Stress Urinary Incontinence

小型企业创新研究(SBIR)第二阶段项目的更广泛影响/商业潜力是加快开发一种新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妇女，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，该设备为女性压力性尿失禁提供谨慎、舒适、易于使用的治疗。通过这项工作获得的技术理解为FDA批准的产品的后续商业化奠定了基础，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采用或维持的治疗方法。该项目建立在成功的第一阶段可行性工作的基础上，在会阴组织附近放置了连续的皮肤电极阵列，以提供足够的电肌肉刺激来促进盆底调理，证明在与持续佩戴相关的条件下仍能保持这一功效。第二阶段的项目目标是开发一种失禁特定的肌肉电刺激器，以与电极阵列一起工作。该系统架构将能够操纵治疗波形，以支持未来的多武装临床研究，旨在测试各种治疗方案的疗效。该系统还将跟踪治疗频率、持续时间和强度，为临床研究人员提供信息。活动将包括设计、原型制造、性能测试、人为因素评估、迭代和电气安全验证。对电极阵列的改进也是预期的。该项目将提供一种适合未来评估的设备，用于人类临床研究、FDA批准和产品商业化。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II 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 commercialization of an 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. This project builds on successful Phase I feasibility work in which a contiguous array of cutaneous electrodes placed proximate the perineal tissue to deliver sufficient electrical muscle stimulation to promote pelvic floor toning were shown to maintain this efficacy under conditions associated with continuous wear. The Phase II project goal is to develop an incontinence specific electrical muscle stimulator to function with the electrode array. The system architecture will enable manipulation of the therapeutic waveform to support future multi-armed clinical studies designed to test the efficacy of various treatment regimens. The system will also track treatment frequency, duration and intensity to provide information to clinical researchers. Activity will include design, prototype fabrication, performance testing, human factors assessments, iteration and electrical safety validation. Refinements to the electrode array are also anticipated. The project will deliver a device suitable for future evaluation a human clinical studies, FDA clearance and product commercialization.