I-Corps: Development of a digital therapeutic device for high tone pelvic floor disorders

I-Corps项目更广泛的影响/商业潜力是开发一种连接的无线设备和应用程序，以指导用户在家中进行盆底物理治疗。在今天的美国，超过3300万女性患有高音调盆底功能障碍（HTPFD），这是一种以盆底肌肉不松弛为特征的盆底神经肌肉疾病，导致排便和排便症状、性功能障碍和盆腔疼痛。由于对病情的认识有限，需要进行详细的骨盆肌筋膜检查进行诊断，患者经常被误诊和治疗不足。在患有HTPFD的女性中，只有500万（不到15%）完成了一线盆底物理治疗。PFPT的潜在障碍是众所周知的，包括高昂的治疗费用/共同支付，远离工作的时间，以及前往经认证的盆腔健康物理治疗师的距离。该装置的商业应用是为了满足市场尚未满足的需求，即在家中进行可能有效的、有指导的自我治疗，这可能减少妇女治疗症状所需的治疗次数，并提高自我治疗的依从性。I-Corps项目的基础是开发一种连接的、无线的骨盆底棒，用于治疗重度盆底功能障碍（HTPFD）。这项提议的技术可能是一种交互式骨盆棒，旨在感知其在阴道内的位置，并与智能手机应用程序实时通信。该项目寻求一种潜在的破坏性解决方案，以解决目前物理治疗远程保健方面的赤字。它可以为HTPFD患者提供与物理疗法合作或单独治疗的机会。将设计专有的空间校准技术，帮助潜在地指导患者通过有针对性的盆底肌肉和指导课程，实时反馈将优化盆底肌肉释放。使用拟议的技术，患者可以跟踪、回顾和分享他们的进展。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this I-Corps project is the potential development of a connected wireless device and app to guide users through pelvic floor physical therapy at home. In the United States today, over 33 million women suffer from high-tone pelvic floor dysfunction (HTPFD), a neuromuscular disorder of the pelvic floor characterized by non-relaxing pelvic floor muscles, resulting in voiding and defecatory symptoms, sexual dysfunction, and pelvic pain. Due to limited awareness of the condition and the need for a detailed myofascial pelvic exam for diagnosis, patients are often underdiagnosed and undertreated. Of women with HTPFD, only 5 million (less than 15%) complete first-line pelvic floor physical therapy treatment. Potential barriers to PFPT are well established and include the high cost/copay of treatment, time away from work, and distances traveled to a certified pelvic health physical therapist. The commercial application of the device is in addressing the unmet market need for a potentially effective, guided, self-treatment performed at home that may reduce the number of therapy sessions necessary for women to treat symptoms and improve self-treatment compliance. This I-Corps project is based on the development of a connected, wireless pelvic floor wand for the treatment of high-tone pelvic floor dysfunction (HTPFD). The proposed technology could be an interactive pelvic wand designed to sense its position intra-vaginally and communicate with a smartphone application in real-time. This project pursues a potentially disruptive solution to the current deficit in physical therapy telehealth. It could broaden the opportunity for HTPFD patients to initiate treatment in collaboration with physical therapy or alone. Proprietary spatial calibration technology will be designed to help potentially guide patients through targeted pelvic floor muscles and coaching sessions and real-time feedback will optimize pelvic floor muscle release. Using the proposed technology, patients may be able to track, review and share their progress over time.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.