Alternative Therapies for Benign Prostate Symptoms

良性前列腺症状的替代疗法

• 批准号: 8147503
• 负责人: Karl J Kreder
• 金额: $ 9.89万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-30 至 2011-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8147503
• 关键词: Acute; Alternative Therapies; American; Benign; Benign Prostatic Hypertrophy; Clinical; Clinical Trials; Credentialing; Data; Data Coordinating Center; Data Quality; Data Reporting; Development; Eligibility Determination; Enrollment; Ensure; Goals; Head; Hormonal; Incontinence; Iowa; Kidney Failure; Laboratories; Manuals; Marketing; Measures; Methods; Minority; Multi-Institutional Clinical Trial; Operative Surgical Procedures; Outcome Measure; Participant; Patients; Phytotherapy; Placebos; Play; Population; Preventive Medicine; Prostate; Prostatic; Protocols documentation; Prunus africana; Publications; Randomized; Recruitment Activity; Recurrence; Reporting; Research; Residual state; Role; Sabal serrulata; Schedule; Site; Stanolone; Symptoms; Testosterone; Time; Ultrasonography; United States; Universities; Urinary Retention; Urinary tract infection; Urology; Visit; clinical care; clinical research site; compliance behavior; design; experience; follow-up; indexing; innovation; men; operation; prevent; primary outcome; protocol development; research clinical testing; treatment center; treatment effect; urologic

DESCRIPTION (provided by applicant): The long-term objectives and specific aims of this proposal are to establish the University of Iowa Department of Urology and Preventive Medicine trials group as a Clinical Evaluation and Treatment Center (CETC) in a multi-institutional research consortium. The purpose of this consortium is to study the effect of phytotherapy using Sernoa repens (saw palmetto) and Pygeum africanum in men with benign prostatic hyperplasia (BPH). A large segment of the United States population uses phytotherapy for treatment of symptoms of BPH, yet there is little scientific data regarding long-term treatment with these agents. Our proposal here at the CETC will enroll 300 patients in this trial during the enrollment period and follow them for the duration of the trial for a minimum of four years and a maximum of six years. The primary outcome measure will be the clinical progression of BPH. The recruitment, marketing, and retention strategies outlined in the following sections will ensure this level of participation as well as maximize the center's ability to recruit minority populations. This center has all the clinical and laboratory support required as stated in the protocol. The following sections outline innovative methods to recruit a large number of men with BPH as well as multiple strategies to ensure long-term compliance and completion of all scheduled follow-up visits. In summary, this proposal outlines what we believe are the outstanding credentials of the University of Iowa Department of Urology and Preventive Medicine to serve as a Clinical Evaluation and Treatment Center for this multi-institutional clinical trial.

描述（由申请人提供）： 本提案的长期目标和具体目标是将爱荷华州大学泌尿外科和预防医学试验组建立为多机构研究联盟中的临床评价和治疗中心（CETC）。该联盟的目的是研究使用白草（锯棕榈）和非洲臀果木对良性前列腺增生（BPH）男性的植物治疗效果。美国人口的很大一部分使用植物疗法治疗BPH的症状，但很少有关于这些药物长期治疗的科学数据。我们在CETC的提案将在招募期间招募300名患者参加本试验，并在试验期间对他们进行至少4年和最多6年的随访。主要结局指标将是BPH的临床进展。以下章节中概述的招募、营销和保留策略将确保这一参与水平，并最大限度地提高中心招募少数民族人口的能力。该中心拥有方案中规定的所有临床和实验室支持。以下章节概述了招募大量BPH男性患者的创新方法以及确保长期依从性和完成所有计划随访访视的多种策略。总之，本提案概述了我们认为爱荷华州大学泌尿外科和预防医学系作为本多机构临床试验的临床评价和治疗中心的出色资质。