CHRONIC PROSTATITIS CLINICAL RESEARCH CENTER

慢性前列腺炎临床研究中心

• 批准号: 2549779
• 负责人: Michel Pontari
• 金额: $ 17.24万
• 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/2549779
• 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（摘自申请人摘要） 这项研究旨在产生一个互动的临床研究网络， 验证临床调查和实验室诊断工具的中心 III类前列腺炎患者的研究方案。 这是一个建议， 被选为开展这些研究的临床中心之一。 寺 大学是特别合格，由于我们的丰富经验， 下尿路炎性疾病，尤其是间质性 膀胱炎（IC），以及各方面的特定和独特的专业知识 的临床和实验室研究。 为实现本研究的目标，我们提出以下建议： 1. 建立并验证慢性前列腺炎统一症状指数。 2. 设计一个标准协议来评估NIDDK标准， 诊断为III类前列腺炎。 这将通过 结果分析：流行病学问卷、生活质量 普查、四杯尿试验、精液生化分析和培养， III类前列腺炎患者的视频尿动力学与 有症状和无症状的对照。 3. 从会阴前列腺活检中识别隐藏的微生物 非细菌性前列腺炎患者聚合酶链序列分析 反应（PCR）扩增的原核16 S核糖体脱氧核酸 （rDNA）。 使用序列数据，设计“签名”引物， 扩增16 S rDNA序列，所述16 S rDNA序列是生物体特异性的， 在个别患者中发现或通常对非细菌性 前列腺炎患者或各类患者。 使用这些签名引物， 在微创临床中鉴定这些相同原核16 SrDNA序列 来自这些相同患者的样本，例如尿液、前列腺液 分泌物（EPS）或精液标本。 把…的存在或不存在联系起来 精液、尿液或精液EPS中的这些原核16 S rDNA序列， 前列腺炎患者的生化、炎症指标和症状评分 和控制随着时间的推移，以确定其使用作为诊断工具， 作为治疗结果的衡量标准。 4. 进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 和培养结果从4玻璃尿液和精液标本使用传统的 培养技术和16 S rDNA PCR技术。