High definition pressure mapping and electromyography for female pelvic floor guided therapy

 描述（由申请人提供）：尿失禁（UI）和膀胱过度活动症（OAB）在女性中非常普遍，其患病率随着年龄的增长而增加。在一项具有代表性的美国调查中，据报道UI影响15%至38%的妇女。OAB患病率估计值在不同研究中差异很大，范围从3%到43%。这些条件是社会尴尬，造成重大的发病率和生活质量的影响。的 骨盆底肌肉（PFM）形成女性骨盆盆的底部，并通过在收缩时主动地支撑骨盆器官并通过其前部和头部动作关闭骨盆开口来帮助维持骨盆。在老年人群中，盆底疾病代表神经泌尿病理学、功能和认知障碍以及组织生物力学条件变化的交叉。治疗选择包括手术、植入电极的骶神经调节、药物、骨盆肌肉和膀胱训练以及肌肉电刺激。到目前为止，还没有标准化的、可重复的工具来以解剖学特定的方式准确评估PFM功能，并将引导肌肉刺激应用于UI和OAB治疗。有必要在成像和定量评估的PFM条件的疾病的有效管理。我们建议开发一种名为Restore-IT的新设备，用于PFM强度和EMG活动的真实的实时可视化，以及在指定位置进行引导UI和OAB治疗的靶向肌肉模拟。所提出的方法是基于阴道触觉成像技术，我们最近在5个已发布的专利中披露，以及其与肌电图（EMG）成像在一个探头中的融合，用于引导治疗。在第一阶段，我们计划开发Restore-IT α原型，对其治疗指导所需的成像性能进行实验室验证和临床评估。

 DESCRIPTION (provided by applicant): Urinary incontinence (UI) and overactive bladder (OAB) are highly prevalent in women and their prevalence is increased with the age. In a representative United States survey, UI was reported to affect from 15% to 38% of women. The OAB prevalence estimates vary considerably among studies, ranging from 3% to 43%. These conditions are socially embarrassing, causing significant morbidity and quality of life impact. The pelvic floor muscles (PFM) form the floor of the female pelvic basin and help maintaining continence by actively supporting the pelvic organs and closing the pelvic openings with their anterior and cephalad action when contracting. In the older population, pelvic floor disorders represent the intersection of neuro-urinary pathology, functional and cognitive impairments, and changing biomechanical conditions of tissues. The treatment options include surgery, sacral neuromodulation with implanted electrodes, medications, pelvic muscle and bladder training, and electrical muscle stimulation. To date, there is no standardized, reproducible tool to accurately assess the PFM function in anatomically specific manner, and to apply guided muscle stimulation for UI and OAB therapy. There is a need in imaging and quantitative assessment of PFM conditions for the effective management of the disorders. We propose to develop a new device entitled Restore-IT for real time visualization of PFM strength and EMG activity and targeted muscle simulation at specified locations for guided UI and OAB therapy. The proposed approach is based on the Vaginal Tactile Imaging technology, we disclosed recently in 5 issued patents, and its fusion with electromyographic (EMG) imaging in one probe to be used for the guided therapy. In the Phase I, we plan development of a Restore-IT α-prototype, bench verification and clinical assessment of its imaging performance needed for the therapy guidance.