Interstitial Cystitis Clinical Research Network (ICCRN)

RFA特别要求申请者确认他们有兴趣和能力参加间质性膀胱炎(IC)的临床治疗试验。女王大学间质性膀胱炎研究小组是在加拿大金斯敦的J.Curtis Nickel博士的领导下成立的，最近扩大参加了NIH ICCTG RCT#2。女王大学间质性膀胱炎研究小组招募了255名患者进行12项临床试验，特别是临床IC治疗研究(这还不包括同期招募进行病因学和诊断研究的许多患者)。作为NIH ICCTG的一部分，女王大学网站到目前为止已经超过了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.Niel)关系密切，后者正在与NIH CPCRN(包括CPCRN RCT#1)合作。前列腺炎研究 据我们所知，女王大学前列腺炎研究中心启动了更多的前列腺炎治疗试验，并招募了比世界上任何此类研究小组都多的患者。这份申请描述了我们的目标是参与拟议的NIH ICCRN以及拟议的泌尿外科慢性盆腔疼痛综合征协作组(UCPPSCG)。我们小组提出了一个临床上相关的定义，包括IC和男性慢性盆腔疼痛综合征。这一定义以慢性生殖器-泌尿系统疼痛/不适为基础，包括尿频紧迫度和无尿频紧迫度两个子类，如果被UCPPSCG采纳，将有助于就要评估的治疗做出决定，并提高IC和CPPS研究参与者的应计比率。我们提出了一项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患者症状的有效性和安全性。女王大学。由Nickel博士担任PI的Site拥有设计、实施和招募IC患者参加临床研究的经验、专业知识和公认的能力，并将成为拟议的ICCRN和UCPPSCG的宝贵合作伙伴。

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.