Chronic Prostatitis Collaborative Research Network CPCRN

描述（由申请人提供）： RFA特别要求申请人确认他们有兴趣和能力参加男性慢性盆腔疼痛综合征（CPPS）的临床治疗试验。大约10年前，在加拿大金斯顿的J. Curtis Nickel博士的领导下，女王大学前列腺炎研究小组成立。在过去的八年里，J.C. Nickel是16项临床试验的主要研究者（或2例主要合作研究者），这些试验招募了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）。作为第一个NIH CPCRN的一部分，女王大学研究中心超过了所有研究的招生配额，包括RCT#1。前列腺炎研究小组与女王大学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。IC研究中心也达到了RCT#1的招募配额。本申请描述了我们参加NIH CPCRN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男性CPPS和IC。该定义基于慢性泌尿生殖道疼痛/不适，包括尿频/尿急和无尿频/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CPPS和IC中研究受试者的累积率。 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CPPS的男性症状的疗效和安全性。Nickel博士作为PI的女王大学研究中心拥有设计、实施和招募临床研究中CPPS患者的经验、专业知识和经证实的能力，将成为拟议的CPCRN和UCPPSCG的宝贵合作伙伴。

DESCRIPTION (provided by applicant): 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 studies and will be a valuable partner in the proposed CPCRN and UCPPSCG.