Fecal Incontinence Treatment Study (FIT Study)

大便失禁治疗研究（FIT 研究）

• 批准号: 9975811
• 负责人: ADIL E. BHARUCHA
• 金额: $ 240万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-18 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9975811
• 关键词: Admission activity; Adverse event; Agreement; Algorithms; Anus; Anxiety; Belief; Biofeedback; Characteristics; Clinic; Clinical; Clinical Research; Colorectal Surgery; Combined Modality Therapy; Common Terminology Criteria for Adverse Events; Cost Analysis; Cost Effectiveness Analysis; Data Coordinating Center; Diabetes Mellitus; Digestive System Disorders; Discipline of Nursing; Educational workshop; Electric Stimulation; Enrollment; Esthesia; Evoked Potentials; Expectancy; Fecal Incontinence; Feces; Frequencies; Geographic Locations; Hospitalization; Infection; Injections; Institutes; Intervention; Kidney Diseases; Knowledge; Lead; Liquid substance; Magnetism; Measures; Medical; Medical Care Costs; Mental Depression; Methods; NIH Program Announcements; Neural Conduction; Outcome; Outcome Measure; Participant; Pathway interactions; Patients; Pelvic Pain; Pelvic floor structure; Physiological; Physiology; Policies; Pragmatic clinical trial; Prediction of Response to Therapy; Predictive Factor; Principal Investigator; Quality of life; Quality-Adjusted Life Years; Questionnaires; Randomized; Randomized Controlled Trials; Recommendation; Recording of previous events; Reporting; Research; Sacral nerve; Safety; Self Efficacy; Severities; Site; Solid; Sphincter; Telephone; Time; Ultrasonography; Universities; alternative treatment; base; cell motility; clinical research site; cohort; comparative cost effectiveness; comparative efficacy; compare effectiveness; cost; cost effectiveness; cost estimate; design; experience; follow-up; inclusion criteria; neural stimulation; neurophysiology; predict clinical outcome; premature; pressure; programs; psychologic; psychological outcomes; psychosocial; recruit; rectal; response; safety assessment; secondary analysis; secondary outcome; sex; sphincter ani muscle structure; symposium; treatment comparison; treatment group; treatment responders; treatment response; treatment site; willingness

ABSTRACT This is an initial application for a U01 in response to PAR-15-067. This program announcement grew out of an NIDDK Workshop held in 2013 to identify pathways for promoting research on fecal incontinence (FI). Conference attendees identified gaps in knowledge and the best approaches to progress, and all identified Biofeedback (BIO), Sacral Neural Stimulation (SNS), and Injections of bulking agents (INJ) in the perianal space as treatments supported by controlled trials, but with no clear indication of which is most effective, safest, and least costly. Outcome measures have been variable, and inclusion criteria have also differed. The recommendation was to compare all 3 using the same paradigm. Aims: (1) Compare all 3 treatments on the basis of efficacy, safety, and cost, as well as secondary outcome measures. (2) Identify physiological, clinical, and psychosocial predictors of who will respond to each treatment. (3) Allow patients who do not respond to the randomly assigned treatment to select a second treatment at 3 months. (4) Compare treatment combinations to see which appears best (uncontrolled). (5) Assess the effects of enhanced Medical Management (MM) on efficacy, safety, and cost (uncontrolled). (6) Compare the cost-effectiveness of BIO, SNS, and INJ for FI throughout the two years. Methods: Select 567 patients appropriate to all treatments including >2 per week solid or liquid FI. A treatment responder is someone with >75% reduction in FI frequency. Primary assessment is 3 months after the beginning of randomized treatment. If patients are responders, they will continue to be studied for 24 months, but if they fail to respond they will be offered alternative treatment and followed. Secondary outcomes include the rate of responding with a 50% decrease in FI, continence, changes on the Bristol Stool Severity scale, FI Quality of Life, and validated severity scales (FI Severity Scale, St. Mark’s FI Severity Scale). Psychological outcomes include the PROMIS Anxiety-7, Depression-8, and Self-Efficacy scales. Costs effectiveness analysis will be based on Quality Adjusted Life Years. Moderators will include (1) physiological assessments (anal ultrasound, anorectal motility, and magnetic evoked potentials); (2) a priori beliefs in treatments (Credibility/Expectancy Questionnaire), quality of life (general and FI specific), sex, and type of FI (passive, urge). The 4 clinical site principal investigators (PIs) are Adil Bharucha (Mayo Clinic), Satish Rao (University of Augusta in Georgia), Ann Lowry (Colon and Rectal Surgery in Minneapolis), and William Whitehead (Chapel Hill, NC) – all senior PIs. The PI of the data coordinating center (DCC) is Marie Gantz, also an experienced PI. This is a collaborative agreement with NIDDK, and Frank Hamilton will participate in program management. A successful outcome will guide treatment algorithms and reimbursement policies.

抽象的 这是响应PAR-15-067的U01的初始应用。该计划公告从一个 NIDDK研讨会于2013年举行，以确定促进粪便失禁研究（FI）的途径。 会议参与者确定了知识的差距和最佳进步方法，所有人都确定了 生物反性（BIO），s骨神经刺激（SNS）和散装剂（ING）的注射 空间作为对照试验支持的治疗方法，但没有明确的迹象表明哪些是最有效的， 最安全，成本最低。结果度量是可变的，纳入标准也有所不同。这 建议是使用相同的范式比较所有3个。目的：（1）比较 效率，安全性和成本以及次要结果指标的基础。 （2）确定身体，临床， 以及谁将对每种治疗做出反应的社会心理预测指标。 （3）允许不反应的患者 随机分配的治疗方法在3个月后选择第二种治疗方法。 （4）比较治疗 组合以查看哪个看起来最好（不受控制）。 （5）评估增强医学的影响 管理（MM）关于有效性，安全性和成本（不受控制）。 （6）比较生物的成本效益， 社交媒体，以及在两年中的IND。方法：选择适合所有治疗的567名患者 包括每周> 2个固体或液体FI。治疗响应者是FI降低75％的人 频率。初级评估是在随机治疗开始后3个月。如果患者是 响应者，他们将继续研究24个月，但是如果他们不响应，他们将提供 替代治疗并随之而来。次要结果包括响应率，降低了50％ FI，持续性，Bristol凳子严重程度尺度，FI生活质量和经过验证的严重程度（FI）的变化 严重程度量表，圣马克的FI严重程度量表）。心理成果包括Promis Encorian-7， 抑郁8和自我效能量表。成本有效性分析将基于质量调整的生活 年。主持人将包括（1）物理评估（肛门超声，肛门直肠运动和磁性 诱发潜力）； （2）治疗的先验信念（信誉/预期问卷），生活质量 （特定于一般和FI），性别和fi类型（被动，冲动）。 4个临床现场主要研究人员（PIS）是 Adil Bharucha（Mayo Clinic），Satish Rao（佐治亚州奥古斯塔大学），Ann Lowry（Colon和直肠 明尼阿波利斯的手术）和威廉·怀特海（William Whitehead）（北卡罗来纳州教堂山） - 所有高级PIS。数据的PI 协调中心（DCC）是玛丽·甘茨（Marie Gantz），也是经验丰富的PI。这是与 NIDDK和弗兰克·汉密尔顿（Frank Hamilton）将参加计划管理。成功的结果将指导 处理算法和报销政策。