Interstitial Cystitis Clinical Research Network (ICCRN)

RFA特别要求申请人确认其参与间质性膀胱炎（IC）临床治疗试验的兴趣和能力。女王大学间质性膀胱炎研究小组由加拿大金斯顿的J. Curtis Nickel博士领导成立，最近扩大到参加NIH ICCTG RCT #2。女王大学间质性膀胱炎研究小组在12项临床试验中招募了255名患者，特别是在临床IC治疗研究中（这不包括同一时期招募的许多患者进行病因学和诊断研究）。作为NIH ICCTG的一部分，女王大学网站迄今为止已经超过了RCT #2的招生配额。间质性膀胱炎研究小组与女王大学前列腺炎研究小组（PI Dr. J.C. Nickel），其正在NIH CPCRN（包括CPCRN RCT#1）中进行合作。前列腺炎研究 中心也达到了RCT#1的招募配额。据我们所知，女王大学前列腺炎研究中心已经启动了更多的前列腺炎治疗试验，并且招募了比世界上任何此类研究小组更多的患者。本申请描述了我们参加NIH ICCRN和泌尿系统慢性盆腔疼痛综合征协作组（UCPPSCG）的目的。我们的小组提出了一个临床相关的定义泌尿系慢性盆腔疼痛综合征包括IC和男性CPPS。该定义基于慢性泌尿生殖道疼痛/不适，包括尿急和非尿急子类别，如果被UCPPSCG采用，将有助于决定待评价的治疗，并增加IC和CPPS中研究受试者的累积率。我们提出了一个基本原理，假设，必要的目的，提出了一个16周的随机安慰剂对照临床试验（采用2X2析因设计），以评估阿米替林和加巴喷丁改善临床诊断为IC的患者的症状的疗效和安全性。皇后大学以Nickel博士为主要研究者的研究中心拥有设计、实施和招募临床研究中IC患者的经验、专业知识和经证实的能力，将成为拟议的ICCRN和UCPPSCG的重要合作伙伴。

The RFA specifically requests that the applicants confirm their interest and ability to take part in clinical treatment trials in Intersitial Cystitis (IC). The Queen's University Intersitial Cystitis Research Group is established under the directorship of Dr. J. Curtis Nickel in Kingston, Canada and recently expanded to take part in the NIH ICCTG RCT #2. The Queen's University Intersitial Cystitis Research Group has enrolled 255 patients in 12 clinical trials, specifically in clinical IC treatment studies (this does not include the many patients recruited for etiology and diagnostic studies during the same time period). As part of the NIH ICCTG, the Queen's University site has exceeded its enrollment quota to date for RCT #2.. The interstitial cystitis research group is closely affiliated with the Queen's University Prostatitis Research Group (PI Dr. J.C. Nickel) which is collaborating in the NIH CPCRN (including CPCRN RCT#1). The Prostatitis research center is also meeting its recruitment quota in RCT#1. To our knowledge the Queen's University Prostatitis Research Center has initiated more prostatitis treatment trials and has enrolled more patients than any such research group worldwide. This application describes our aim to participate in the proposed NIH ICCRN as well as the proposed urological chronic pelvic pain syndromes collaborative group (UCPPSCG). Our group is proposing a clinically relevant definition of the urologic chronic pelvic pain syndromes encompassing both IC and male CPPS. This definition, based on chronic genito-urinary pain/discomfort with subcategories for urinary frequency urgency and no urinary frequency urgency will, if adopted by the UCPPSCG, facilitate decisions on treatments to be evaluated and increase the accrual rate of study participants in both IC and CPPS. We develop a rationale, hypothesis, objectives necessary to propose a 16 week randomized placebo controlled clinical trial (employing 2X2 factorial design) to evaluate the efficacy and safety of amitriptyline and gabapentin for the amelioration of symptoms in patients with a clinical diagnosis of IC. The Queen's University. site with Dr. Nickel as PI has the experience, expertise and the proven ability to design, implement and enroll patients with IC in clinical strudies and will be a valuable partner in the proposed ICCRN and UCPPSCG.