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，女王大学前列腺炎研究小组在 J. Curtis Nickel 博士的领导下在加拿大金斯敦成立。在过去 8 年中，J.C. Nickel 博士一直是 16 项临床试验的主要研究者（或在 2 个案例中是主要联合研究者），这些临床试验招募了 935 名患者，旨在评估 13 种治疗方式。女王大学网站已招募了 357 名患者，特别是临床治疗试验患者（这不包括同一时期招募的数百名患者进行病因学和诊断研究）。作为首届 NIH CPRN 的一部分，女王大学网站超出了包括 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. Nickel）密切相关，该研究小组正在 NIH ICCTG RCT#1 中进行合作。 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与提议的 NIH CPCRN 以及提议的泌尿科慢性盆腔疼痛综合征协作组 (UCPPSCG) 的目标。 我们的小组正在提出泌尿科慢性盆腔疼痛综合征的临床相关定义，包括男性 CPPS 和 IC。这一定义基于慢性泌尿生殖疼痛/不适，并分为尿频/尿急和无尿频/尿急子类别，如果被 UCPPSCG 采用，将有助于评估治疗决策，并提高 CPPS 和 IC 中研究参与者的应计率。 我们提出了必要的基本原理、假设和目标，以提出一项为期 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 的男性症状的有效性和安全性。 Nickel 博士担任 PI 的女王大学网站拥有设计、实施和招募 CPPS 患者参加临床研究的经验、专业知识和经过验证的能力，并将成为拟议的 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.