Pathophysiology, diagnosis and biofeedback therapy in fecal incontinence using fecobionics

摘要 大便失禁(FI)影响着每7个美国人中的1个，发病率不断上升，构成了主要的医疗负担。 其病理生理机制知之甚少，因此缺乏有效的治疗方法(S)。一位批评者 取得进展的障碍是缺乏全面的、与生理相关的和实用的诊断测试 用于确定潜在的机制(S)。目前的测试提供了不完整或相互冲突的信息 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 肌肉在维持可控性和促进排便中的作用，以及肛门直肠功能障碍如何通过 使用一种名为Fecobionics(电子模拟凳子)的新技术来评估其诊断和 治疗效用。生物仿生学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、取向和粘弹性特性。随着硬件的大幅升级， 软件和图形用户界面，新的仿生设备绘制疏散过程中的几何轮廓 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 通过肛门直肠的仿生装置的移动将提供未知的和新的机械学见解 关于肛门直肠生理，包括管腔内压力变化，肛门肌长度-张力关系， 在代用凳子移动过程中产生的阻力及其变形性，以及 正常人和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 菲尔。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患者的肛门扩张和模拟排便过程中使用生物仿生学。2) 阐明单个肌肉成分的病理生理特征和生物力学特性， 外、内肛门括约肌和耻骨直肠肌的应用及对FI患者的比较 与正常的受试者对照；以及3)评估生物仿生学作为生物反馈治疗(BT)的使用和 FI患者监测工具确定治疗成功的预测因素，通过随机进行 生物反馈治疗(FBT)与传统办公室治疗的对照试验 生物反馈疗法(OBT)我们的建议旨在通过测试粪便替代品来转移当前的FI研究 进行BT检查，而不是细小的测压探头，检查多维生理变化 (即压力、变形性、生物力学、矢状和地形变化)以及临床结果 追随英国电信。我们的方案的独特之处在于用无线仿生设备模拟凳子，并 详细检查在健康和FI患者中的机械基础。我们项目的影响是 为FI的肛门直肠功能和病理生理提供新的机制理解，并验证临床 一种新的、高度集成的设备用于诊断和促进生物反馈治疗 前所未有的图形化反馈给患者的机械感官动作。

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.