Chronic Prostatitis Collaborative Research Network CPCRN

描述(由申请人提供)： RFA特别要求申请者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。女王大学前列腺炎研究小组是大约10年前在加拿大金斯敦由J.Curtis Nickel博士领导成立的。在过去的8年里，J.C.镍博士一直是16项临床试验的首席研究员(或在2个案例中担任主要联合研究员)，这些试验招募了935名患者，用于评估13种治疗方法。女王大学网站招收了357名患者，特别是在临床治疗试验中(这还不包括同一时期招募的数百名病因学和诊断研究患者)。作为第一个NIH CPCRN的一部分，女王大学的网站超过了包括RCT#1在内的所有研究的招生配额。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.Ni)密切相关，后者正在与NIH ICCTG RCT#1合作。IC研究中心也达到了RCT#1的招募配额。这份申请描述了我们参与拟议的NIH CPCRN和拟议的泌尿外科慢性盆腔疼痛综合征协作组(UCPPSCG)的目标。 我们小组提出了一个临床上相关的定义，包括男性慢性盆腔疼痛综合征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/尿急和无尿频/尿急亚类，如果被UCPPSCG采纳，将有助于就要评估的治疗做出决定，并提高CPPS和IC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)来评估阿米替林和加巴喷丁改善临床诊断为CPPS的男性患者症状的有效性和安全性。由Nickel博士担任PI的皇后大学网站拥有设计、实施和招募CPPS患者参加临床研究的经验、专业知识和公认的能力，将是拟议的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.