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.

抽象的 缺乏障碍会影响25％的人口，他们的认可和治疗不佳。发病率 包括慢性便秘在内的缺乏障碍疾病正在上升，并带来了重大的医疗保健负担。这 这些疾病的基本机制通常不太了解。排便阻塞（Dyssynergia） 有几个原因，并以四个亚型细分。尽管患病率和发病率很高，诊断和 治疗选择很少。肛门直肠生理测试中的一个重要问题是缺乏生理学 相关和实用的诊断测试，用于识别基本机制以识别适当的治疗方法。 当前的诊断测试提供了不完整且经常矛盾的信息，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。生物反馈疗法是一种公认​​的排便障碍，但尽管存在很大 潜在的和有希望的结果，生物反馈疗法仅在专业中心进行，应更接近 到护理点。该小型R01提案的目的是监视和预测生物反馈的结果 基于新型模拟粪便设备的史无前例的综合视觉反馈的治疗，称为繁殖力。 该设备是具有正常粪便的一致性和形状的电子模拟粪便。繁殖力会 通过可视化几何形状（横截面 排便前后的模拟粪便的区域，装置的弯曲和形状）和模拟剖面。 中心假设是模仿自然动态排便的繁殖力设备可提供有效 关于缺乏障碍系统的各种组件的直肠排空尝试的数据，例如肛门的音调 括约肌和紫眼肌肌肉以及机械感应性能。目的是监视和预测 基于基于机制和高度集成的数据的生物反馈疗法，可以在期间可视化 肛门直肠神经肌肉运动。对于拟议的研究，我们将选择Dyssynergia患者，他们将是 在生物反馈疗法之前，之中和之后用繁殖物进行监测。假设是繁殖力数据 与传统技术相比，根据便秘评分的症状将更好地关联 数据可用于预测治疗的反应者和非反应者。我们的提议试图改变当前 通过使用新型设备，通过模拟提供机械洞察的新装置，在便秘疗法方面进行研究 在病理生理上排便，并检查机械变化多维的变化：压力， 可变形性，生物力学和地形变化，以监测阻塞患者的潜在缺陷 排便，尤其是在患者中。我们提案的独特方面是用bionics模拟凳子 集成了多个变量的设备，这些变量检查了阻塞排便的机械基础。这 该项目的影响是为便秘提供新的理解并预测响应者。这将有助于 使用繁殖力作为生物反馈治疗工具开发创新的肠道管理计划。