Chronic Prostatitis Collaborative Research Network

慢性前列腺炎合作研究网络

• 批准号: 7258421
• 负责人: Michel Pontari
• 金额: $ 23.7万
• 依托单位: TEMPLE UNIV OF THE COMMONWEALTH
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-01 至 2009-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7258421
• 关键词: Ancillary Study; Antidepressive Agents; Basic Science; Categories; Chronic Prostatitis; Clinical; Clinical Trials; Condition; Etiology; Interstitial Cystitis; Investigation; Minority; Numbers; Pathogenesis; Patients; Pharmaceutical Preparations; Population; Qualifying; Randomized Clinical Trials; Recruitment Activity; Research; Research Personnel; Subgroup; Symptoms; Universities; chronic neuropathic pain; chronic pelvic pain; clinically relevant; design; experience; interest; men; novel; prostatitis; randomized placebo controlled trial; urban area; urologic

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.

描述(由申请人提供)： 这项研究旨在形成一个由临床中心组成的互动研究网络，以开发和进行随机临床试验，以评估III型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将调查这两个实体的组织中对间质性膀胱炎(IC)患者进行类似的研究。这是一项建议，将被选为进行这些研究的临床中心之一。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，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留住男性进行慢性前列腺炎/慢性盆腔疼痛综合征(CP/CPPS)的研究。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，有机会接触到大量的少数民族人口。为了实现这项研究的目标，我们提出了一种抗抑郁药物的随机安慰剂对照试验，该药物已显示出对慢性神经病理性疼痛的疗效。我们详细介绍了我们在成功招募和留住男性进行慢性前列腺炎试验方面的经验，以及我们在试验设计中遇到陷阱的经验。提供了分组分析的计划。我们还将参加泌尿外科慢性盆腔疼痛综合征协作组。我们提供了证据，证明了我们对CP/CPPS和IC的比较和表征的持续兴趣和研究。在制定一个临床相关的定义泌尿外科慢性盆腔疼痛综合征的问题进行了讨论。