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 粪便尿失禁（FI）影响了7个美国人中有1个，其发病率上升，造成了重大的医疗保健负担。 它的病理生理学知之甚少，因此缺乏有效治疗。批判 进步的障碍是缺乏全面的，生理上的诊断测试 用于识别基本机制。当前测试提供不完整或冲突的信息 与症状和治疗结果无关。我们的目标是确定厌食症的作用 保持持续性和促进排便的肌肉，以及启用直肠故障如何导致FI 使用一种称为繁殖力学（电子模拟凳子）的新技术来评估其诊断和 治疗效用。繁殖学具有正常粪便的一致性和形状，可以记录压力，交叉 剖面区域，方向和粘弹性特性。具有大量升级的硬件， 软件和图形用户界面，新的Fecobionics设备在撤离期间绘制了几何配置文件 并将它们与压力（力）和弯曲的同时变化联系起来。我们的核心假设是 繁殖力设备通过肛门运动的运动将提供未知和新的机械见解 关于厌食直肠生理，包括腔内压力变化，肛门肌肉长度张紧关系， 替代凳运动过程中产生的抗性及其可变形性，以及可扩展的性 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 fi。因此，我们的具体目的是：1）确定肛门括约肌的长度张紧特性 在肛门扩张期间和模拟疏散期间，使用正常受试者和FI患者中的繁殖力。 2） 阐明单个肌肉成分的病理生理特征和生物力学特性， 使用粪便装置并比较FI患者 正常受试者控制； 3）评估使用繁殖力作为生物反馈治疗（BT）和 FI患者的监测工具，以确定治疗成功的预测因子，通过执行随机 基于办公室的粪便辅助生物反馈疗法（FBT）的对照试验 生物反馈疗法（ABT）。我们的建议旨在通过测试凳子代理来转移当前的FI研究 进行BT而不是进行稀薄的测量探针并检查多维生理变化 （即压力，可变形性，生物力学，矢量和地形变化）以及临床结果 遵循BT。我们提案的独特方面是使用无线仿生设备和 详细检查健康和FI患者的机械基础。我们项目的影响是 提供对FI中厌食功能和病理生理学的新机械理解并验证临床 一种新颖，高度集成的设备的实用性，用于诊断和促进生物反馈治疗 机械感觉动作患者的前所未有的图形反馈。