Interstitial Cystitis Clinical Research Network

间质性膀胱炎临床研究网络

• 批准号: 6794191
• 负责人: CHRISTOPHER K PAYNE
• 金额: $ 25万
• 依托单位: STANFORD UNIVERSITY
• 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 2008-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6794191
• 关键词: chronic pain; clinical research; clinical trials; cooperative study; diagnosis design /evaluation; diagnosis quality /standard; drug screening /evaluation; experimental designs; human subject; human therapy evaluation; interdisciplinary collaboration; interstitial cystitis; mathematical model; methadone; model design /development; outcomes research; patient oriented research; quality of life; urinary tract disorder chemotherapy; urinary tract pharmacology

DESCRIPTION (provided by applicant): This application proposes that Stanford University Center for Female Urology and NeuroUrology participate as one of several National Clinical Centers in a cooperative effort to develop clinical trials for the study of interstitial cystitis (IC). The Principal Investigator intends to participate fully as a member of the steering committee in designing and carrying out multicenter randomized controlled clinical trials (RCTs). The investigative group at Stanford will work in parallel with the centers conducting trials for investigation of chronic prostatitis. A simultaneous application for that effort is being submitted. This is a critical juncture for IC research. While appreciation of the prevalence and impact of the disease is growing, little headway has been made in identifying the underlying etiology or finding reliably effective treatment. More importantly, the very definition of IC and pelvic pain syndromes is under active debate--are all patients with pelvic pain simply varying manifestations of a single underlying disorder or are there important clinical distinctions between IC, vulvadynia, chronic prostatitis, and pelvic floor dysfunction? The relevance of standard diagnostic tools has been challenged. Bladder distention under anesthesia may be neither sensitive nor specific. Neither urodynamic testing nor bladder biopsy provides specific diagnostic information. A simple office trial of intravesical potassium instillation purported to identify IC totally failed to predict response to therapy in a RCT. These and other critical issues will only be settled by carefully designed, large scale RCTs. The ICCRN should focus on the following specific aims: 1) determining the clinical utility of currently diagnostic tests for IC and evaluating new tests 2) developing evidence based algorithms for the work-up of IC patients involved in clinical research 3) developing relevant clinical protocols that involve the entire spectrum of IC patients 4) to test novel therapies for IC as they become available. Stanford is ideally suited for this project due to a long history of interest in IC, a Principal Investigator with recognized expertise in clinical research, an ethnically diverse patient base, and demonstrable success recruiting patients for IC research.

描述（由申请人提供）： 本申请建议斯坦福大学女性泌尿外科和神经泌尿外科中心作为几个国家临床中心之一参与合作开发间质性膀胱炎（IC）研究的临床试验。主要研究者计划作为指导委员会成员全面参与多中心随机对照临床试验（RCT）的设计和实施。斯坦福大学的研究小组将与进行慢性前列腺炎研究试验的中心平行工作。目前正在同时提交这项工作的申请。 这是集成电路研究的关键时刻。虽然人们越来越认识到这种疾病的流行和影响，但在确定根本病因或找到可靠有效的治疗方法方面进展甚微。更重要的是，IC和骨盆疼痛综合征的定义正在积极辩论中-所有骨盆疼痛患者只是单一潜在疾病的不同表现，还是IC，外阴痛，慢性前列腺炎和骨盆底功能障碍之间存在重要的临床区别？标准诊断工具的相关性受到质疑。麻醉下的膀胱扩张可能既不敏感也不特异。尿动力学检查和膀胱活检均不能提供特异性诊断信息。在一项RCT中，一项旨在确定IC的膀胱内钾灌注的简单办公室试验完全无法预测对治疗的反应。 这些和其他关键问题只能通过精心设计的大规模随机对照试验来解决。ICCRN应侧重于以下具体目标： 1)确定目前IC诊断测试的临床效用并评估新测试 2)为参与临床研究的IC患者的检查开发基于证据的算法 3)制定涉及所有IC患者的相关临床方案 4)以测试IC的新疗法，因为它们变得可用。 斯坦福大学非常适合这个项目，因为它对IC的兴趣由来已久，主要研究者在临床研究方面具有公认的专业知识，种族多样化的患者基础，以及为IC研究招募患者的明显成功。