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: 10521701
• 负责人: Hans Gregersen
• 金额: $ 76.28万
• 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/10521701
• 关键词: 3D ultrasound; Affect; American; Anus; Area; Biofeedback Training; Biomechanics; Bionics; Catheters; Characteristics; Circular layer of muscularis propria of anal canal; Clinical; Computer software; Conflict (Psychology); Constipation; Data; Defecation; Development; Devices; Diagnosis; Diagnostic; Diagnostic Equipment; Diagnostic tests; Disease; Fecal Incontinence; Feces; Feedback; Functional disorder; Geometry; Goals; Health; Healthcare; Incidence; Individual; Length; Manometry; Maps; Measurement; Mechanics; Methodology; Methods; Monitor; Movement; Muscle; Outcome; Outcome Measure; Patients; Pattern; Physiological; Physiology; Play; Predictive Factor; Property; Randomized Controlled Trials; Research; Resistance; Role; Shapes; Symptoms; System; Testing; Therapeutic; Thinness; Treatment outcome; Vagina; base; effective therapy; experimental study; graphical user interface; insight; interactive tool; multidimensional data; new technology; novel; pressure; sphincter ani muscle structure; success; symptom treatment; tool; treatment strategy; vector; 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.

摘要 大便失禁（FI）影响着七分之一的美国人，发病率不断上升，造成了重大的医疗负担。 其病理生理机制知之甚少，因此缺乏有效的治疗方法。一个关键 进展的障碍是缺乏全面的、生理相关的和实用的诊断测试 以确定潜在机制。目前的测试提供不完整或相互矛盾的信息 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 肌肉在维持排便和促进排便，以及肛门直肠功能障碍如何导致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。随着硬件的大幅升级， 通过软件和图形用户界面，新的Fecobionics设备可以在疏散过程中绘制几何轮廓图 并将它们与压力（力）和弯曲的同时变化相关联。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和新的机械见解 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， 在替代粪便的运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患者中使用Fecobionics在肛门扩张期间和在模拟排空期间。（二） 阐明单个肌肉成分的病理生理学特征和生物力学特性， 使用Fecobionics装置的肛门外括约肌、肛门内括约肌和耻骨直肠肌，并比较FI患者 与正常受试者对照;以及3）评估Fecobionics作为生物反馈治疗（BT）的使用，以及 FI患者中的监测工具，通过进行随机化 粪生物离子辅助生物反馈治疗（FBT）与传统的基于生物反馈治疗的对照试验 生物反馈疗法（OBT）。我们的建议旨在通过测试粪便替代物来改变目前的FI研究， 执行BT而不是薄测压探头，并检查多维生理变化 (i.e.,压力、变形能力、生物力学、向量和地形变化）以及临床结果 在BT之后我们的提案的独特之处在于用无线仿生设备模拟排便， 详细检查健康和FI患者的机械基础。我们项目的影响是 为FI中的肛门直肠功能和病理生理学提供新的机制理解，并验证临床 用于诊断和促进生物反馈治疗的新型高度集成装置的实用性 前所未有的图形反馈给病人的机械感觉行动。