Clinical Evaluation & Treatment Center for Benign Prostatic Hyperplasia

描述(由申请人提供)： 良性前列腺增生症(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。在过去的十年里，在确定这种异常的特征并用药物治疗(如α-受体阻滞剂和5-α还原酶抑制剂)和微创外科技术(如支架、激光、热疗等)方面取得了重大进展。尽管如此，近年来非传统医学疗法在LUTS中的应用大大增加。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工具的限制。由于这些原因，有必要在大规模、随机、安慰剂对照的长期试验中评估非传统药物，如锯棕榈和非洲鬼臼。在本申请中，我们提出了一项这样的研究，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、方案遵从性和保留性的其他方法。我们描述了我们开发最终协议并合作执行它的意愿。

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.