CHRONIC PROSTATITIS CLINICAL RESEARCH CENTER

慢性前列腺炎临床研究中心

• 批准号: 2770687
• 负责人: Michel Pontari
• 金额: $ 30.19万
• 依托单位: TEMPLE UNIV OF THE COMMONWEALTH
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-09-30 至 2002-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2770687
• 关键词: antibiotics; anticonvulsants; biopsy; clinical research; diagnosis design /evaluation; health surveys; human subject; human therapy evaluation; nucleic acid sequence; outcomes research; polymerase chain reaction; prostate; prostatitis; quality of life; questionnaires; ribosomal DNA; semen; sign /symptom; urinary tract disorder chemotherapy; urinary tract disorder diagnosis; urine

DESCRIPTION (Taken from the applicant's Abstract) This study is designed to spawn an interactive research network of clinical centers to validate survey and laboratory diagnostic tools for clinical study protocols of men with category III prostatitis. This is a proposal to be chosen as one of the clinical centers carrying out these studies. Temple University is particularly qualified due to our extensive experience with inflammatory disease of the lower urinary tract, especially Interstitial Cystitis (IC), and the combined specific and unique expertise in all aspects of the clinical and laboratory studies. To fulfill the aims of this study we propose the following: 1. Develop and validate a uniform symptom index for chronic prostatitis. 2. Design a standard protocol to assess the NIDDK criteria for the diagnosis of category III prostatitis. This will be accomplished by analysis of results of: epidemiological questionnaire, quality of life survey, four glass urine test, semen biochemical analysis and culture, and videourodynamics of category III prostatitis patients in comparison to symptomatic and asymptomatic controls. 3. Identify occult organisms in perineal prostate biopsies from nonbacterial prostatitis patients by sequence analysis of polymerase chain reaction (PCR) amplified prokaryotic 16S ribosomal deoxy nucleic acid (rDNA). Using the sequence data, design "signature" primers allowing amplification of 16S rDNA sequences that are either specific for organisms found in individual patients or generally specific for nonbacterial prostatitis patients or classes of patients. Use these signature primers to identify these same prokaryotic 16S rDNA sequences in less invasive clinical specimens from these same patients such as urine, expressed prostatic secretions (EPS) or semen specimens. Correlate the presence or absence of these prokaryotic 16S rDNA sequences in semen, urine, or EPS with semen biochemistry, inflammation index and symptom score in prostatitis patients and controls over time to determine their use as either a diagnostic tool or as a measurement of treatment outcome. 4. Perform the following multicenter treatment protocols: a) empiric antibiotic therapy; b) alpha adrenergic antagonists using videourodynamic finding; c) gabapentin for treatment of the associated pain; and d) correlation of thrice weekly prostatic massage with changes in inflammation and culture results from 4-glass urine and semen specimens using traditional culture techniques and PCR for 16S rDNA.

描述(摘自申请人的摘要) 这项研究旨在催生一个互动的临床研究网络 为临床验证调查和实验室诊断工具的中心 研究男性III型前列腺炎的治疗方案。这是一项旨在 被选为进行这些研究的临床中心之一。圣殿 大学特别有资格，因为我们有丰富的经验 下尿路炎症性疾病，尤指间质性 膀胱炎(IC)，以及各方面的特定和独特专业知识相结合 临床和实验室研究。 为了实现本研究的目标，我们提出以下建议： 1.制定和验证慢性前列腺炎的统一症状指数。 2.设计标准协议以评估NIDDK标准 诊断为III型前列腺炎。这将通过以下方式实现 结果分析：流行病学问卷、生活质量 调查，四杯尿检，精液生化分析和培养，以及 III型前列腺炎患者的视频尿流动力学与 有症状和无症状对照。 3.鉴定会阴前列腺活检组织中的隐秘生物 非细菌性前列腺炎患者的聚合酶链测序分析 聚合酶链式反应扩增原核生物16S核糖体脱氧核酸 (RDNA)。利用序列数据，设计允许 扩增生物体特有的16S rDNA序列 发现于个别患者或一般为非细菌性的 前列腺炎患者或各类患者。使用这些签名底漆来 在侵袭性较小的临床中鉴定这些相同的原核16S rDNA序列 从这些患者的尿液等样本中检测出前列腺癌 分泌物(EPS)或精液标本。关联存在或不存在 这些原核生物的16S rDNA序列存在于精液、尿液或精液中 前列腺炎患者生化、炎症指标和症状积分的研究 和控件，以确定它们作为诊断工具或 作为治疗结果的衡量标准。 4.执行以下多中心治疗方案：a)经验性 抗生素治疗；b)使用视频尿动力学的α肾上腺素能拮抗剂 发现；c)加巴喷丁用于治疗相关疼痛；和d) 每周三次前列腺按摩与炎症变化的相关性 培养结果来自4个玻璃杯的尿液和精液样本 16S rDNA培养技术及聚合酶链式反应。