Chronic Prostatitis Collaborative Research Network CPCRN

RFA特别要求申请人确认其参与临床研究的兴趣和能力。 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顿成立，由J. Curtis Nickel博士领导 大约十年前在过去的八年里，J.C.镍一直是主要研究者（或在2 16项临床试验，招募了935例患者，旨在评价13种治疗 方式。女王大学的研究中心已经招募了357名患者，特别是在临床治疗试验中（这是一项研究）。 不包括在同一时期招募的数百名用于病因学和诊断研究的患者 期间）。作为第一个NIH CPCRN的一部分，女王大学网站超过了所有人的入学配额。 研究包括RCT#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（PI Dr. J.C. Nickel），该公司正在NIH ICCTG RCT#1中合作。的 IC研究中心也达到了RCT#1的招募配额。本申请描述了我们的目标， 参与拟议的NIH CPCRN以及拟议的泌尿系统慢性盆腔疼痛综合征 协作组（UCPPSCG）。 我们的小组正在提出一个临床相关的定义泌尿系慢性盆腔疼痛综合征 包括男性CPPS和IC。该定义基于慢性泌尿生殖道疼痛/不适， 尿频/尿急和无尿频/尿急的子类别，如果被采用， UCPPSCG，促进对待评价治疗的决策，并提高研究的累积率 参加了CPPS和IC。 我们提出了一个基本原理，假设，目标，提出了一个16周的随机安慰剂 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） 和加巴喷丁用于改善临床诊断为CPPS的男性的症状。 皇后大学的网站与博士.镍作为PI有经验，专业知识和证明的能力， 在临床研究中设计、实施和招募CPPS患者，并将成为 建议的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.