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。

• 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
• 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

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.

摘要 排便障碍影响25%的人口，他们认识和治疗不足。的发生率 包括慢性便秘在内的排便障碍正在增加，并且它构成了主要的医疗负担。的 这些疾病的潜在机制通常还不清楚。排便障碍（协同失调） 有几个原因，并细分为四个亚型。尽管患病率和发病率很高， 治疗选择很少。肛门直肠生理学测试中的一个重要问题是缺乏生理学上的 相关和实用的诊断测试，以确定潜在的机制，以确定适当的治疗。 目前的诊断测试提供的信息不完整，而且往往相互矛盾，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相关性很差 结果。生物反馈疗法是一种成熟的治疗排便障碍的疗法， 潜在的和有希望的结果，生物反馈疗法只在专门的中心进行，应该在更近的地方进行。 到护理点。这个小R01提案的目的是监测和预测生物反馈的结果 基于前所未有的综合视觉反馈的治疗，这种视觉反馈来自称为Fecobionics的新型模拟粪便装置。 该装置是电子模拟粪便，具有正常粪便的稠度和形状。Fecobionics将 通过可视化几何（横截面），为检查者提供排便的机械理解 装置的面积、弯曲和形状）和排便前和排便期间模拟粪便的测压曲线。 中心假设是模拟自然动态排便的Fecobionics装置提供有效的 排便系统各组成部分的直肠排空尝试数据，如肛门张力 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 生物反馈治疗基于基于机制和高度集成的数据，可以在治疗过程中可视化。 肛门直肠神经肌肉锻炼。对于拟议的研究，我们将选择协同失调患者， 在生物反馈治疗之前、期间和之后用Fecobionics监测。假设是Fecobionics数据 与传统技术相比，将更好地与基于便秘评分的症状相关， 数据可用于预测对治疗的应答者和无应答者。我们的建议旨在改变目前 通过使用一种新型设备进行便秘治疗的研究，该设备通过模拟 排便的病理生理和检查机制的变化多维度：压力， 变形性、生物力学和地形变化，以监测阻塞性肺动脉瘤患者的潜在缺损。 排便，特别是在协同失调。我们的提案的独特之处是用仿生学来模拟凳子 一种整合多个变量的设备，可以检查排便障碍的机械基础。的 该项目的影响是摆脱便秘的新的理解和预测反应。这将有利于 利用Fecobionics作为生物反馈治疗工具，开发创新的肠道管理计划。