Chronic Prostatitis Collaborative Research Network

描述（由申请人提供）： 本研究旨在形成一个临床中心的互动研究网络，以开发和实施随机临床试验，以评估III类前列腺炎患者的新疗法。该研究小组将进行辅助研究，以调查慢性前列腺炎的病因和发病机制，并与研究人员一起在一个组织中对间质性膀胱炎（IC）患者进行类似研究，该组织将调查这两种疾病。这是一个被选为将开展这些研究的临床中心之一的建议。坦普尔大学特别有资格这样做，原因有很多。我们在慢性前列腺炎和间质性膀胱炎方面都有丰富的经验，并且是慢性前列腺炎合作研究网络（CPCRN）的参与中心之一。我们在过去的临床试验中非常成功地招募和保留了慢性前列腺炎/慢性骨盆疼痛综合征（CP/CPPS）研究的男性。研究人员在慢性盆腔疼痛的临床和基础科学研究方面都有专业知识。我们位于城市地区，可以接触到大量的少数民族人口。为了实现这项研究的目的，我们提出了一个随机安慰剂对照试验的抗抑郁药物，已显示出疗效的慢性神经性疼痛条件。我们已经详细介绍了我们成功招募和保留慢性前列腺炎试验男性的经验，以及我们在试验设计中遇到的陷阱。提供了亚组分析计划。我们还将参加泌尿系统慢性盆腔疼痛协作组。我们提供的证据，我们正在进行的兴趣和研究的比较和表征CP/CPPS和IC。在制定一个临床相关的定义泌尿系统慢性盆腔疼痛综合征的问题进行了讨论。

DESCRIPTION (provided by applicant): This study is designed to form an interactive research network of clinical centers to develop and conduct randomized clinical trials to evaluate novel therapies in patients with category III prostatitis. The research group will conduct ancillary studies to investigate the etiology and pathogenesis of chronic prostatitis, and also participate with researchers performing similar studies in patients with Interstitial Cystitis (IC) in an organization which will investigate both entities. This is a proposal to be chosen as one of the clinical centers which will be carrying out these studies. Temple University is particularly qualified to do so for a number of reasons. We have extensive experience with both Chronic Prostatitis and Interstitial Cystitis, and were one of the participating centers in the Chronic Prostatitis Collaborative Research Network (CPCRN). We have been very successful in past clinical trials recruiting and retaining men for studies of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). The investigators have expertise in both clinical and basic science investigation in chronic pelvic pain. We are located in an urban area and have access to a large minority population. To fulfill the aims of this study we propose a randomized placebo controlled trial of an antidepressant medication which has shown efficacy in chronic neuropathic pain conditions. We have detailed our experience with successfully recruiting and retaining men for trials of chronic prostatitis, as well as our experience with pitfalls in trial design. Plans for subgroups analyses are provided. We will also participate in the Urologic Chronic Pelvic Pain Syndromes Collaborative Group. We provide evidence of our ongoing interest and studies in the comparison and characterization of both CP/CPPS and IC. Issues in developing a clinically relevant definition of urologic chronic pelvic pain syndromes are discussed.