Fecobionics monitoring and prediction of biofeedback therapy outcome in patients with obstructed defecation.

Fecobionics 监测和预测排便阻塞患者生物反馈治疗结果。

基本信息

批准号：
10568352
负责人：
Hans Gregersen
金额：
$ 37万
依托单位：
CALIFORNIA MEDICAL INNOVATIONS INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-03-01 至 2026-02-28
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10568352
关键词：
Abdomen Affect Aftercare Aging American Area Ataxia Biofeedback Training Biomechanics Bionics Chronic Classification Clinical Management Clinical Trials Constipation Cost Savings Data Defecation Defecography Defect Development Devices Diagnosis Diagnostic Diagnostic tests Diet Dimensions Disease Electronics Exercise Expenditure Fecal Incontinence Feces Friends Goals Healthcare Healthcare Systems High Prevalence Home Incidence Individual Intestines Lateral Length Liquid substance Magnetic Resonance Imaging Manometry Maps Measurement Medicine Monitor Muscle Outcome Patients Pattern Pelvic Floor Muscle Pelvic floor structure Pelvis Physiological Physiology Play Population Positioning Attribute Posture Procedures Process Property Quality of life Radiation Reaction Records Rectum Research Resolution Rest Risk Role Sensory Shapes Specialized Center Symptoms System Technology Test Result Testing Time Training Treatment outcome Visualization Water anorectal disorder care burden clinical practice cost data integration graphical user interface improved indexing innovation insight laxative neuromuscular new technology novel optimal treatments outcome prediction point of care pressure programs randomized trial rectal responders and non-responders response sphincter ani muscle structure success therapy outcome tool treatment responders visual feedback

项目摘要

ABSTRACT Defecatory disorders affect 25% of the population and they are poorly recognized and treated. The incidence of defecatory disorders including chronic constipation is rising and it poses a major healthcare burden. The underlying mechanisms for these disorders are often not well understood. Obstructed defecation (dyssynergia) has several causes and is subdivided in four subtypes. Despite the high prevalence and incidence, diagnostics and treatment options are sparse. A significant problem in anorectal physiology testing is a lack of physiologically relevant and practical diagnostic test for identifying the underlying mechanisms to identify proper treatment. Current diagnostic tests provide incomplete and often conflicting information because they do not simulate feces or the defecation process. Not surprisingly, results of these tests correlate poorly with symptoms and treatment outcomes. Biofeedback therapy is a well-established therapy for obstructed defecation but despite the substantial potential and promising results, biofeedback therapy is only done at specialized centers and should be advanced closer to the point of care. The objective of this small R01 proposal is to monitor and predict the outcome of biofeedback therapy based on unprecedented integrated visual feedback from the novel simulated feces device termed Fecobionics. The device is electronic simulated feces that has the consistency and shape of normal stool. Fecobionics will provide mechanistic understanding of defecation for the examiner by visualizing the geometric (cross-sectional area, bending and shape of device) and manometric profiles of the simulated feces before and during defecation. The central hypothesis is that the Fecobionics device that mimics natural dynamic defecation provides valid data on rectal emptying attempts for the various components of the defecatory system such as the tone of anal sphincters and puborectalis muscle, and on mechanosensory properties. The objective is to monitor and predict biofeedback therapy based on mechanism-based and highly integrated data that can be visualized during anorectal neuromuscular exercises. For the proposed studies, we will select dyssynergia patients, who will be monitored with Fecobionics before, during and after biofeedback therapy. The hypothesis is Fecobionics data will correlate better to symptoms based on constipation scores than conventional technologies and that such data can be used to predict responders and non-responders to therapy. Our proposal seeks to shift current research in constipation therapy by use of a novel device that provides mechanistic insights by simulating defecation pathophysiologically and examining the mechanistic changes multi-dimensionally: Pressure, deformability, biomechanics, and topographic changes to monitor underlying defects in patients with obstructed defecation, especially in dyssynergia. The unique aspects of our proposal are to simulate stool with a bionics device that integrates multiple variables that examine the mechanistic underpinnings of obstructed defecation. The impact of this project is to shed new understanding of constipation and to predict responders. This will facilitate development of innovative bowel management programs using Fecobionics as the biofeedback therapy tool.

抽象的排便障碍影响着 25% 的人口，但人们对排便障碍的认识和治疗却很差。发病率包括慢性便秘在内的排便障碍正在增加，并构成了重大的医疗负担。这这些疾病的潜在机制通常尚不清楚。排便阻塞（协同失调）有多种原因，可分为四种亚型。尽管患病率和发病率很高，但诊断和治疗选择很少。肛门直肠生理学测试的一个重要问题是缺乏生理学相关且实用的诊断测试，用于确定潜在机制，从而确定适当的治疗方法。当前的诊断测试提供的信息不完整且经常相互矛盾，因为它们不模拟粪便或排便过程。毫不奇怪，这些测试的结果与症状和治疗的相关性很差结果。生物反馈疗法是治疗排便阻塞的一种行之有效的疗法，但尽管有大量的潜在且有希望的结果，生物反馈疗法仅在专门中心进行，并且应该进一步推进到护理点。这个小型 R01 提案的目标是监测和预测生物反馈的结果疗法基于来自名为 Fecobionics 的新型模拟粪便装置的前所未有的综合视觉反馈。该设备是电子模拟粪便，具有正常粪便的稠度和形状。 Fecobionics将通过可视化几何（横截面）为检查者提供对排便的机械理解设备的面积、弯曲度和形状）以及排便前和排便期间模拟粪便的测压曲线。中心假设是模仿自然动态排便的 Fecobionics 装置提供了有效的有关排便系统各个组成部分（例如肛门音调）的直肠排空尝试的数据括约肌和耻骨直肠肌，以及机械感觉特性。目标是监测和预测生物反馈疗法基于基于机制和高度集成的数据，这些数据可以在过程中可视化肛门直肠神经肌肉练习。对于拟议的研究，我们将选择协同失调患者，他们将在生物反馈治疗之前、期间和之后使用 Fecobionics 进行监测。假设是 Fecobionics 数据与传统技术相比，基于便秘评分的症状将更好地相关数据可用于预测对治疗有反应和无反应的人。我们的建议旨在改变当前使用一种新颖的设备进行便秘治疗研究，该设备通过模拟提供机械见解排便病理生理学并多维检查机械变化：压力，变形能力、生物力学和地形变化，以监测阻塞患者的潜在缺陷排便，尤其是协同失调。我们提案的独特之处是用仿生学模拟粪便该设备集成了多个变量，可检查排便阻塞的机制基础。这该项目的影响是加深对便秘的新认识并预测反应者。这将有利于使用 Fecobionics 作为生物反馈治疗工具开发创新的肠道管理计划。