Clinical Evaluation & Treatment Center for BPH

临床评价

• 批准号: 6668549
• 负责人: GERALD Louis ANDRIOLE
• 金额: $ 31.32万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-30 至 2009-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6668549
• 关键词: aging; alternative medicine; benign prostate hyperplasia; clinical research; cooperative study; human middle age (35-64); human old age (65+); human therapy evaluation; longitudinal human study; male; medicinal plants; patient oriented research; plant extracts; urinary tract disorder; urinary tract disorder chemotherapy

DESCRIPTION (provided by applicant): Lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) are one of the most common disorders of the aging U.S. male. Over the last decade significant advances have been made in characterizing this abnormality and treating it with medical therapy (such as alpha blockers and 5 alpha reductase inhibitors) and minimally invasive surgical techniques (such as stents, lasers, hyperthermia and others). Despite this, use of non-traditional medical therapies for LUTS has greatly increased in recent years. Most trials evaluating these agents are limited by small size, short study interval and absence of standardized testing instruments. For these reasons there is a need to evaluate non-traditional agents such as saw palmetto and pygeum Africanum in a large scale, randomized, placebo-controlled, long-term trial. In this application, we propose one such study, describe our clinical research environment, including patient population, facilities, personnel, experience with prior studies, and other methods to assure recruitment, protocol compliance, and retention for such a study. We describe our willingness to develop a final protocol and collaborate in performing it.

描述（由申请人提供）： 良性前列腺增生 (BPH) 引起的下尿路症状 (LUTS) 是美国老年男性最常见的疾病之一。在过去的十年中，在表征这种异常并通过药物治疗（例如 α 阻滞剂和 5 α 还原酶抑制剂）和微创手术技术（例如支架、激光、热疗等）进行治疗方面取得了重大进展。尽管如此，近年来非传统药物治疗 LUTS 的使用大大增加。大多数评估这些药物的试验都受到规模小、研究间隔短和缺乏标准化测试仪器的限制。由于这些原因，需要在大规模、随机、安慰剂对照的长期试验中评估非传统药物，例如锯棕榈和非洲臀果木。在此申请中，我们提出了一项此类研究，描述了我们的临床研究环境，包括患者群体、设施、人员、先前研究的经验以及确保此类研究的招募、方案合规性和保留的其他方法。我们描述了我们制定最终协议并合作执行它的意愿。