Chronic Prostatitis Collaborative Research Network

慢性前列腺炎合作研究网络

• 批准号: 7036605
• 负责人: ANTHONY J SCHAEFFER
• 金额: $ 25.91万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-05 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7036605
• 关键词: alternative medicine; chronic disease /disorder; clinical research; clinical trials; cooperative study; disease /disorder etiology; human subject; interstitial cystitis; male; male reproductive system disorder diagnosis; pain; pathologic process; patient oriented research; pelvis; plant extracts; prostatitis; reproductive system disorder chemotherapy; reproductive system pharmacology; saw palmetto; urinary tract disorder chemotherapy

DESCRIPTION (provided by applicant): This proposal is in response to an invitation for a cooperative agreement (contract) for one of ten clinical centers to collaboratively establish, perform, maintain and evaluate multiple therapeutic trials, either sequentially or concurrently for treatments of prostatitis through the collection and analysis of information and clinical samples from patients with the disorder. The long-term objective will be attained by: 1. Developing a protocol(s) and manual of operations through the joint efforts of the Steering Committee consisting of members of the clinical centers, data coordinating center, and the NIDDK project scientist. The investigator from the clinical centers in conjunction with the data coordinating center, will have responsibility in developing the protocol(s). 2. Recruiting and admitting patients into the study who have met agreed upon diagnostic entry criteria, have standard demographic information, symptoms related to prostatitis and who will provide clinical samples collected at established intervals will be enrolled. Northwestern's proposed clinical trial is to conduct a prospective multi-center randomized blinded placebo controlled trial of Saw palmetto (SP) or Pygeum africanum (PA) or placebo in patients with symptoms of chronic pelvic pain syndrome (CPPS). Because of the widespread use of these medications for the treatment of CPPS and lower urinary tract symptoms in men, and the neat total lack of well-performed studies on the efficacy and long-term effects, a placebo controlled trial is needed as defined using the CPCRN criterion.

描述（由申请人提供）： 该提案是为了响应十个临床中心之一的合作协议（合同）邀请，以合作建立、执行、维护和评估多项治疗试验，通过收集和分析前列腺炎患者的信息和临床样本，顺序或同时治疗前列腺炎。长期目标将通过以下方式实现： 1. 由临床中心、数据协调中心和NIDDK项目科学家组成的指导委员会共同努力制定方案和操作手册。临床中心的研究者与数据协调中心一起负责制定方案。 2. 招募和接纳符合商定的诊断进入标准、具有标准人口统计信息、与前列腺炎相关的症状并且愿意提供按规定时间间隔收集的临床样本的患者将被纳入研究。 西北大学拟议的临床试验是对有慢性盆腔疼痛综合征（CPPS）症状的患者进行锯棕榈（SP）或非洲臀果木（PA）或安慰剂的前瞻性多中心随机盲安慰剂对照试验。由于这些药物广泛用于治疗男性 CPPS 和下尿路症状，并且完全缺乏关于疗效和长期影响的良好研究，因此需要根据 CPRN 标准进行安慰剂对照试验。