Beaumont Interstitial Cystitis Clinical Research Network

博蒙特间质性膀胱炎临床研究网络

• 批准号: 7235256
• 负责人: KENNETH M PETERS
• 金额: $ 23.7万
• 依托单位: WILLIAM BEAUMONT HOSPITAL RESEARCH INST
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-01 至 2010-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7235256
• 关键词: Adverse event; Ancillary Study; Chronic; Clinical Research; Clinical Research Protocols; Clinical Treatment; Clinical Trials; Clinical Trials Cooperative Group; Clinical trial protocol document; Committee Members; Data Coordinating Center; Dose; Enrollment; Interstitial Cystitis; Measures; Medical; Monitor; Morphine; Newly Diagnosed; Numbers; Outcome; Patients; Rate; Recruitment Activity; Reporting; Research; Role; Sacral nerve; Standards of Weights and Measures; Symptoms; Urine; Urology Department, Hospital; Work; chronic pelvic pain; clinically relevant; implantation; protocol development; response; urologic

DESCRIPTION (provided by applicant): The objective is to work in a collaborative effort with other centers of excellence to develop and execute clinical trials for the treatment of interstitial cystitis. Established mechanisms are in place at William Beaumont Hospital, Department of Urology for enrolling and retaining interstitial cystitis patients into clinical research trials. We will work closely with the Interstitial Cystitis Research Network (ICCRN), the Data Coordinating Center, the Steering committee members, and the Urological Chronic Pelvic Pain Syndromes collaborative group to develop clinical research protocols along with ancillary studies on IC. The specific aims are to determine the role of sacral nerve modulation in treating interstitial cystitis symptoms in established IC patients who have failed traditional medical management or in newly diagnosed IC patients who did not respond to an operative hydro distension and at least 6 months of standard IC therapy. Response rates of sacral nerve modulation in the established IC (> 12 months) and newly diagnosed (<12 months) will be compared. We will use the outcomes criteria already established by the Interstitial Cystitis Clinical Trials Group and in addition, Morphine Dose Equivalents will be monitored before and after permanent implantation of the neuro generator. Adverse events and complications will be monitored. Ancillary studies as agreed upon by the ICCRN will be carried out in conjunction with the clinical trial.

描述（由申请人提供）： 目标是与其他卓越中心合作开发和执行治疗间质性膀胱炎的临床试验。威廉博蒙特医院泌尿科已建立机制，用于招募和保留间质性膀胱炎患者参加临床研究试验。我们将与间质性膀胱炎研究网络 (ICCRN)、数据协调中心、指导委员会成员和泌尿科慢性盆腔疼痛综合征协作小组密切合作，制定临床研究方案以及 IC 的辅助研究。具体目的是确定骶神经调节在治疗传统医疗治疗失败的已确诊 IC 患者或对手术水扩张和至少 6 个月的标准 IC 没有反应的新诊断 IC 患者中治疗间质性膀胱炎症状的作用治疗。将比较已确诊的 IC（> 12 个月）和新诊断的 IC（< 12 个月）的骶神经调节反应率。我们将使用间质性膀胱炎临床试验组已经制定的结果标准，此外，将在神经发生器永久植入之前和之后监测吗啡剂量当量。将监测不良事件和并发症。经 ICCRN 同意的辅助研究将与临床试验一起进行。