Pathophysiology, diagnosis and biofeedback therapy in fecal incontinence using fecobionics

使用fecobionics治疗大便失禁的病理生理学、诊断和生物反馈治疗

• 批准号: 10670930
• 负责人: Hans Gregersen
• 金额: $ 71.74万
• 依托单位: CALIFORNIA MEDICAL INNOVATIONS INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10670930
• 关键词: 3D ultrasound; Affect; American; Anus; Area; Biofeedback Training; Biomechanics; Bionics; Catheters; Characteristics; Circular layer of muscularis propria of anal canal; Clinical; Constipation; Data; Defecation; Development; Devices; Diagnosis; Diagnostic; Diagnostic Equipment; Diagnostic tests; Dimensions; Disease; Electronics; Fecal Incontinence; Feces; Feedback; Functional disorder; Geometry; Goals; Health; Healthcare; Incidence; Individual; Length; Manometry; Maps; Measurement; Mechanics; Methodology; Methods; Monitor; Movement; Muscle; Outcome; Outcome Assessment; Outcome Measure; Patients; Pattern; Physiological; Physiology; Prediction of Response to Therapy; Predictive Factor; Property; Randomized, Controlled Trials; Research; Resistance; Role; Shapes; Symptoms; System; Testing; Therapeutic; Thinness; Treatment outcome; Vagina; care burden; dynamic system; effective therapy; experimental study; graphical user interface; improved; insight; interactive tool; invention; multidimensional data; new technology; novel; pressure; sphincter ani muscle structure; success; tool; treatment strategy; viscoelasticity; visual feedback; wireless

ABSTRACT Fecal incontinence (FI) affects 1 in 7 Americans with a rising incidence that poses a major healthcare burden. Its pathophysiology is poorly understood and consequently there is dearth of effective treatment(s). A critical barrier to progress has been the lack of comprehensive, physiologically-relevant and practical diagnostic test for identifying the underlying mechanism(s). Current tests provide either incomplete or conflicting information that do not correlate with symptoms and treatment outcomes. Our goal is to determine the role of anorectal muscles in maintaining continence and facilitating defecation, and how anorectal malfunctions can cause FI by using a novel technology called Fecobionics (an electronic simulated stool) to evaluate its diagnostic and therapeutic utility. Fecobionics has the consistency and shape of normal stool that can record pressures, cross- sectional area, orientation, and viscoelastic properties of the anorectum. With heavily upgraded hardware, software and graphical user interface, the new Fecobionics device map the geometric profiles during evacuation and relate them to simultaneous changes in pressures (forces) and bending. Our central hypothesis is that the movement of the Fecobionics device through the anorectum will provide unknown and new mechanistic insights on anorectal physiology including intraluminal pressure changes, anal muscle length-tension relations, resistance generated during movement of the surrogate stool and its deformability, as well as distensibility of the anal sphincters in normal subjects and FI patients. This multidimensional data could facilitate new treatments for FI. Accordingly, our Specific Aims are to: 1) Determine the length-tension properties of the anal sphincters using Fecobionics in normal subjects and FI patients during anal distension and during simulated evacuation. 2) Elucidate the pathophysiological characteristics and biomechanical properties of individual muscle components, external, internal anal sphincter and puborectalis muscle using the Fecobionics device and comparing FI patients with normal subject controls; and 3) Evaluate the use of Fecobionics as a biofeedback treatment (BT) and monitoring tool in FI patients to determine the predictors for treatment success, by performing a randomized controlled trial of Fecobionics-assisted Biofeedback Therapy (FBT) versus conventional Office-based Biofeedback Therapy (OBT). Our proposal seeks to shift current FI research by testing a stool surrogate for performing BT as opposed to a thin manometry probe and examine the multi-dimensional physiologic changes (i.e., pressure, deformability, biomechanics, vectoral and topographic changes) as well as clinical outcome following BT. The unique aspect of our proposal is to simulate stooling with a wireless bionics device and examine in detail the mechanistic underpinnings in health and in FI patients. The impact of our project is to provide new mechanistic understanding of anorectal function and pathophysiology in FI and validate the clinical utility of a novel, highly integrated device for diagnostics and facilitation of biofeedback therapy with an unprecedented graphical feedback to the patient of mechanosensory actions.

抽象的 大便失禁 (FI) 影响着七分之一的美国人，其发病率不断上升，造成了重大的医疗负担。 对其病理生理学知之甚少，因此缺乏有效的治疗方法。一个批评的 进展的障碍是缺乏全面的、生理相关的和实用的诊断测试 用于识别潜在机制。当前的测试提供的信息不完整或相互矛盾 与症状和治疗结果无关。我们的目标是确定肛门直肠的作用 维持节制和促进排便的肌肉，以及肛门直肠功能障碍如何通过以下方式导致 FI 使用一种名为 Fecobionics（电子模拟粪便）的新技术来评估其诊断和 治疗效用。 Fecobionics 具有正常粪便的稠度和形状，可以记录压力、交叉 肛门直肠的截面积、方向和粘弹性。凭借硬件的大幅升级， 软件和图形用户界面，新的 Fecobionics 设备在疏散过程中绘制几何轮廓 并将它们与压力（力）和弯曲的同时变化联系起来。我们的中心假设是 Fecobionics 装置通过肛门直肠的运动将提供未知的新机制见解 肛门直肠生理学，包括腔内压力变化、肛门肌肉长度-张力关系、 代孕大便运动过程中产生的阻力及其变形性和膨胀性 正常受试者和 FI 患者的肛门括约肌。这种多维数据可以促进新的治疗方法 FI。因此，我们的具体目标是： 1) 确定肛门括约肌的长度张力特性 在正常受试者和 FI 患者肛门扩张期间和模拟排便期间使用 Fecobionics。 2） 阐明各个肌肉成分的病理生理学特征和生物力学特性， 使用 Fecobionics 装置观察肛门外括约肌、肛门内括约肌和耻骨直肠肌并比较 FI 患者 具有正常的受试者对照； 3) 评估 Fecobionics 作为生物反馈治疗 (BT) 的用途，以及 FI 患者的监测工具，通过执行随机试验来确定治疗成功的预测因素 Fecobionics 辅助生物反馈疗法 (FBT) 与传统基于办公室的疗法的对照试验 生物反馈疗法（OBT）。我们的提案旨在通过测试粪便替代物来改变当前的 FI 研究 执行 BT（与细测压探头不同）并检查多维生理变化 （即压力、变形性、生物力学、矢量和地形变化）以及临床结果 继BT之后。我们提案的独特之处在于使用无线仿生设备模拟排便， 详细检查健康和 FI 患者的机制基础。我们项目的影响是 提供对 FI 中肛门直肠功能和病理生理学的新机制理解并验证临床 一种新颖的、高度集成的设备的实用性，用于诊断和促进生物反馈治疗 向患者提供前所未有的机械感觉动作图形反馈。