Fecal Incontinence Treatment Study (FIT Study)

大便失禁治疗研究（FIT 研究）

• 批准号: 10907221
• 负责人: ADIL E. BHARUCHA
• 金额: $ 137.72万
• 依托单位: MAYO CLINIC ROCHESTER
• 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/10907221
• 关键词: Admission activity; Adult; 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; Educational workshop; Electric Stimulation; Enrollment; Esthesia; Evoked Potentials; Expectancy; Fecal Incontinence; Feces; Frequencies; Geographic Locations; Hospitalization; Infection; Injections; Intervention; Kidney Diseases; Knowledge; Liquid substance; Magnetism; Measures; Medical; Medical Care Costs; Mental Depression; Methods; NIH Program Announcements; Neural Conduction; Nursing Homes; Outcome; Outcome Measure; Participant; Pathway interactions; Patients; Pelvic Pain; Pelvic floor structure; Persons; 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; Rectum; Reporting; Research; Sacral nerve; Safety; Self Efficacy; Severities; Site; Solid; Sphincter; Telephone; Time; Universities; alternative treatment; cell motility; clinical research site; cohort; comparative cost effectiveness; comparative efficacy; compare effectiveness; cost; cost comparison; cost effectiveness; cost estimate; cost per quality-adjusted life year; design; efficacy evaluation; experience; follow-up; improved; inclusion criteria; neural stimulation; neurophysiology; predict responsiveness; premature; pressure; programs; psychological distress; 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; ultrasound; 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.

摘要