Chronic Prostatitis Collaborative Research Network CPCRN

RFA特别要求申请者确认他们有兴趣和能力参加临床 男性慢性盆腔疼痛综合征(CPPS)的治疗试验。女王大学前列腺炎 研究小组在加拿大金斯敦的J.Curtis Nickel博士的领导下成立 大约10年前。在过去的8年里，J.C.Nike博士一直是首席研究员(或在2年内 16项临床试验的病例、首席联合研究员)，招募了935名患者，旨在评估13种治疗方法 医疗模式。女王大学网站已经招收了357名患者，特别是临床治疗试验(这 不包括同期招募进行病因学和诊断研究的数百名患者 句号)。作为第一届NIH CPCRN的一部分，女王大学的网站超过了所有人的招生配额 研究包括随机对照试验1.前列腺炎研究小组与女王大学关系密切 间质性膀胱炎研究小组(J.C.Nike博士)，该小组正在与NIH ICCTG RCT#1合作。 IC研究中心也完成了RCT#1的招聘配额。这份申请描述了我们的目标 参与拟议的NIH CPCRN以及拟议的泌尿外科慢性盆腔疼痛综合征 合作小组(UCPPSCG)。 我们小组提出了一个与临床相关的泌尿系慢性盆腔疼痛综合征的定义 包括男性CPPS和IC。这一定义基于慢性生殖器-泌尿系统疼痛/不适 尿频/急性子类别和无尿频/急性子类别，如果由 UCPPSCG，促进关于接受评估的治疗的决定，并提高研究的应收率 CPPS和IC的参与者。 我们提出了16周随机安慰剂的基本原理、假设和目标。 评价阿米替林疗效和安全性的临床对照试验(采用2×2析因设计) 加巴喷丁用于改善临床诊断为CPPS的男性患者的症状。 女王大学的网站，由Nickel博士担任PI，拥有经验、专业知识和被证明的能力 设计、实施和招募有CPPS的患者参加临床研究，并将成为 拟议的CPCRN和UCPPSCG。

The RFA specifically requests that the applicants confirm their interest and ability to take part in clinical treatment trials in chronic pelvic pain syndrome (CPPS) in men. The Queen's University Prostatitis Research Group was established under the directorship of Dr. J. Curtis Nickel in Kingston, Canada approximately 10 years ago. In the last 8 years, Dr. J.C. Nickel has been the principal investigator (or in 2 cases principal co-investigator) of 16 clinical trials enrolling 935 patients designed to evaluate 13 treatment modalities. The Queen's University site has enrolled 357 patients, specifically in clinical treatment trials (this does not include the hundreds of patients recruited for etiology and diagnostic studies during the same time period). As part of the first NIH CPCRN, the Queen's University site exceeded its enrollment quota for all studies including RCT#1. The prostatitis research group is closely affiliated with the Queen's University Interstitial Cystitis Research Group (PI Dr. J.C. Nickel) which is collaborating in the NIH ICCTG RCT#1. The IC research center is also meeting its recruitment quota in RCT#1. This application describes our aim to participate in the proposed NIH CPCRN 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 male CPPS and IC. 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 CPPS and IC. 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 men with a clinical diagnosis of CPPS. 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 CPPS in clinical strudies and will be a valuable partner in the proposed CPCRN and UCPPSCG.