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

这个I-Corps项目的更广泛的影响/商业潜力是连接无线设备和应用程序的潜在开发，以指导用户在家中进行骨盆底物理治疗。在当今的美国，超过3300万女性患有高张力骨盆底功能障碍（HTPFD），这是一种骨盆底神经肌肉疾病，其特征在于骨盆底肌肉不松弛，导致排尿和排便症状、性功能障碍和骨盆疼痛。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，患者往往诊断不足，治疗不足。在患有HTPFD的女性中，只有500万（不到15%）完成了一线骨盆底物理治疗。PFPT的潜在障碍已经确立，包括治疗的高成本/共付额，远离工作的时间，以及前往经认证的骨盆健康物理治疗师的距离。该器械的商业应用是为了满足未满足的市场需求，即在家中进行潜在有效的、指导性的自我治疗，这可能会减少女性治疗症状所需的治疗次数，并提高自我治疗的依从性。这个I-Corps项目是基于开发一种连接的无线骨盆底棒，用于治疗高音调骨盆底功能障碍（HTPFD）。 拟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的不足。它可以扩大HTPFD患者与物理治疗合作或单独开始治疗的机会。专有的空间校准技术将被设计为帮助潜在地引导患者通过有针对性的骨盆底肌肉和教练课程，实时反馈将优化骨盆底肌肉的释放。使用拟议的技术，患者可能能够跟踪，审查和分享他们的进展随着时间的推移。这个奖项反映了NSF的法定使命，并已被认为是值得通过使用基金会的智力价值和更广泛的影响审查标准进行评估的支持。

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.