Clinical Trial Development in Chronic Pelvic Pain Syndr*

慢性盆腔疼痛综合征的临床试验进展*

• 批准号: 7235712
• 负责人: Daniel Shoskes
• 金额: $ 23.7万
• 依托单位: CLEVELAND CLINIC LERNER COM-CWRU
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-07 至 2010-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7235712
• 关键词: Acupuncture procedure; Ally; Ancillary Study; Basic Science; Biochemical; Categories; Chronic; Chronic Prostatitis; Clinic; Clinical; Clinical Trials; Complementary therapies; Condition; Development; Disease; Enrollment; Erectile dysfunction; Florida; Functional disorder; Genetic Polymorphism; Induced Hyperthermia; Infection; Inflammation; Intervention; Laboratories; Molecular; Neuropsychology; Newly Diagnosed; Oxidative Stress; Pain; Pain management; Patients; Pelvis; Phytotherapy; Polymerase Chain Reaction; Purpose; Randomized Clinical Trials; Rate; Research Design; Spasm; Specialist; Syndrome; Time; United States National Institutes of Health; Water; Work; chronic pain; chronic pelvic pain; cytokine; design; prostatitis; rectal; response; success

DESCRIPTION (provided by applicant): Chronic Pelvic Pain Syndrome (CPPS) is a prevalent multifactorial disorder with variable and often disappointing response to therapy. There is evidence for infection, inflammation and neuromuscular spasm as the underlying cause in different patients despite identical clinical presentation. Large multicenter clinical trials are required to help delineate effective therapies and to identify which patients have the highest chance of success for a particular intervention. The Chronic Prostatitis Clinic at the Cleveland Clinic Florida has a high volume of patients, both newly diagnosed and longstanding. We have done numerous clinical trials in chronic prostatitis with rapid enrolment, 100% accrual of set targets and high rates of retention. We have a team of clinical specialists in allied fields important to the understanding of this condition, including experts in erectile dysfunction, rectal dysfunction, chronic pain management, complementary therapies (acupuncture, phytotherapy) and neuropsychology. We also maintain a basic science laboratory which would be equipped to perform any necessary molecular or biochemical ancillary studies such as real time PCR, oxidative stress markers, cytokines and genetic polymorphisms. Through our participation in the CPCRN and first NIH chronic prostatitis randomized clinical trial, we have demonstrated the ability to work collaboratively and to participate in study design and execution. As an example of a potential clinical trial, a study of water induced thermotherapy is outlined.

描述（由申请人提供）： 慢性骨盆疼痛综合征（CPPS）是一种常见的多因素疾病，对治疗的反应多变且往往令人失望。有证据表明，感染、炎症和神经肌肉痉挛是不同患者的根本原因，尽管临床表现相同。需要大型多中心临床试验来帮助描述有效的治疗方法，并确定哪些患者在特定干预中有最高的成功机会。佛罗里达克利夫兰诊所的慢性前列腺炎诊所有大量的患者，包括新诊断的和长期的。我们在慢性前列腺炎方面进行了大量的临床试验，入组速度快，100%达到设定目标，保留率高。我们拥有一支由相关领域的临床专家组成的团队，这些领域对了解这种疾病非常重要，包括勃起功能障碍，直肠功能障碍，慢性疼痛管理，补充疗法（针灸，植物疗法）和神经心理学专家。我们还拥有一个基础科学实验室，配备设备进行任何必要的分子或生化辅助研究，如真实的时间PCR，氧化应激标记，细胞因子和遗传多态性。通过参与CPCRN和首个NIH慢性前列腺炎随机临床试验，我们证明了合作以及参与研究设计和执行的能力。作为一个潜在的临床试验的例子，水诱导热疗的研究概述。