ALTERNATIVE THERAPIES FOR BENIGN PROSTATIC SYMPTOMS

良性前列腺症状的替代疗法

• 批准号: 7418318
• 负责人: MICHAEL J NASLUND
• 金额: $ 19.88万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 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 2010-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7418318
• 关键词: Acute; Alcohol or Other Drugs use; Alternative Therapies; Benign; Benign Prostatic Hypertrophy; Bladder; Blood; Blood Chemical Analysis; Clinical; Conduct Clinical Trials; Controlled Clinical Trials; Count; Data; Data Collection; Development; Diagnostic; Disease; Double-Blind Method; Enrollment; Europe; Evaluation; Exclusion Criteria; Hormones; Induced Hyperthermia; International; Kidney Failure; Lead; Literature; Manuals; Maryland; Measurement; Operative Surgical Procedures; Outcome; Patients; Pharmaceutical Preparations; Physical Examination; Phytotherapy; Placebo Control; Prostate; Prostatectomy; Prostatic; Prostatic hypertrophy; Protocols documentation; Prunus africana; Publications; Purpose; Quality of life; Questionnaires; Randomized; Randomized Clinical Trials; Rate; Recording of previous events; Recurrence; Research Ethics Committees; Research Personnel; Residual volume; Sabal serrulata; Safety; Score; Serum; Sexual Health; Site; Symptoms; Techniques; Treatment Efficacy; Ultrasonography; United States; Universities; Urinalysis; Urinary Incontinence; Urinary Retention; Urinary tract infection; Urination; Urology; design; experience; men; prevent; prospective; research clinical testing; size; treatment center; urinary

DESCRIPTION (provided by applicant): The purpose of this request is to establish a cooperative group of approximately 10 prostate evaluation and treatment centers nationwide which will develop and conduct a prospective, randomized, double-blind, placebo controlled clinical trial to determine whether Saw Palmetto(SP) and/or Pygeum Africanum(AP) can prevent the clinical progression of benign prostatic hyperplasia (BPH). BPH is a common disease in men over 50 which can lead to bothersome voiding symptoms, urinary retention, permanent bladder damage, renal failure, urinary tract infections, urosepsis or urinary incontinence. Treatment options with documented efficacy include medication, several thermotherapy options, and surgical prostatectomy. Phytotherapy is another treatment option for BPH which is used widely in Europe and is experiencing increasing utilization in the United States. Two common phytotherapeutic agents SP and PA. Despite the widespread use of these substances, there is no convincing data in the literature which demonstrates efficacy for the treatment of BPH. These phytotherapeutic substances do appear to be safe from the patients' perspective. The objective of this trial is to determine if SP and/or PA can prevent the clinical progression of BPH, as defined by the development of: acute urinary retention, renal insufficiency due to BPH, recurrent urinary tract infections, urinary incontinence, or an increase in the international prostate symptom score (IPSS) of 4 or more points over a four year trial. Parameters to be assessed in the subjects enrolled in this trial include IPSS, peak urinary flow rate, post void residual volumes, quality of life and sexual health questionnaires, prostate size determined by prostatic ultrasound, blood count and blood chemistries, urinalysis, serum hormone levels, a history and physical examination. Patients will be assessed every 3 months over a four year trial period. The chosen group of collaborators will meet to design the protocol including diagnostic criteria, inclusion/exclusion criteria, safety measurements and quality of life outcome measurements. The trial will commence after the protocol has been developed, an operations manual has been completed and data collection techniques have been established. Each site will obtain IRB approval of the final protocol. When the study is complete and the data has been analyzed, publication of relevent results will be done.

描述（由申请人提供）： 该请求的目的是建立一个大约10个前列腺评估和治疗中心的合作组，该集团将在全国范围内开发和进行一项前瞻性，随机，双盲，安慰剂对照临床试验，以确定是否Saw Palmetto（SP）和/或Pygeum是否非洲人（AP）可以防止良性前列腺增生（BPH）的临床进展。 BPH是50岁以上男性的一种常见疾病，可能导致造成疾病的症状，泌尿率保留，永久性膀胱损伤，肾脏衰竭，尿路感染，尿道虫或尿失禁。具有证明功效的治疗选择包括药物，几种热药选择和手术前列腺切除术。 植物疗法是BPH的另一种治疗选择，在欧洲广泛使用，并且正在美国的利用率增加。两种常见的植物治疗剂SP和PA。尽管这些物质广泛使用，但文献中没有令人信服的数据证明了BPH治疗的功效。从患者的角度来看，这些植物治疗物质似乎确实是安全的。 该试验的目的是确定SP和/或PA是否可以防止BPH的临床进展，如：急性尿位retention屈，由于BPH而引起的肾脏不足，复发性尿路感染，尿失禁或增加在四年试验中，在国际前列腺症状评分（IPS）中为4分或更多。该试验注册的受试者中要评估的参数包括IPS，峰值尿流量，空隙后残留体积，生活质量和性健康问卷，前列腺超声和血液计数，血液计数和血液化学，尿液分析，血清激素水平确定的前列腺大小，历史和体格检查。在四年试验期间，将每3个月对患者进行一次评估。 选定的合作者将开会以设计协议，包括诊断标准，包含/排除标准，安全测量和生活质量结果测量。该试验将在制定协议后开始，已完成操作手册，并建立了数据收集技术。每个站点将获得最终协议的IRB批准。研究完成并分析数据后，将完成相关结果。