Benign prostate hyperplasia: minimally invasive surgery

良性前列腺增生：微创手术

• 批准号: 6439399
• 负责人: ROBERT F DONNELL
• 金额: $ 10万
• 依托单位: MEDICAL COLLEGE OF WISCONSIN
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-30 至 2006-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6439399
• 关键词: adult human (21+); benign prostate hyperplasia; blood tests; clinical trials; cooperative study; disease /disorder prevention /control; human subject; human therapy evaluation; hyperthermia therapy; laser therapy; longitudinal human study; magnetic resonance imaging; male; microwave radiation; outcomes research; patient oriented research; prostate surgery; quality of life; questionnaires; relapse /recurrence; statistics /biometry; ultrasound; urinalysis; urinary catheterization

DESCRIPTION (provided by applicant): The specific aims of this proposal are to establish the Division of Urology, the Medical College of Wisconsin as a clinical center of excellence for the multi-institutional NIDDK trial entitled "Minimally Invasive Surgical Therapies Treatment Consortium for Benign Prostatic Hyperplasia." The planning for this clinical trial center has been performed to ensure the center?s success in meeting the long-term objectives of the multi-center trial. Specifically, this proposal provides detailed information to establish our ability to meet recruitment goals including minority populations. The following sections outline fail-safe mechanisms in this center design to ensure patient eligibility, data accuracy and efficient data reporting. Two additional considerations central to the design of this clinical center have been the need to maintain patient compliance throughout the duration of enrollment and follow-up, and the need to communicate effectively with the Biostatistical Coordinating Center for this multi-institutional trial. These tasks will be performed in a timely, efficient, accurate and professional manner to ensure the validity of the data contributed to the trial. This, together with similar contributions from the other clinical trial centers, should allow the test hypothesis to be answered, specifically to evaluate the safety and long-term efficacy of minimally invasive therapies for lower urinary tract symptoms. Our study center will participate as members of a group of investigators who will conduct multiple randomized clinical trials, either sequentially or concurrently, of minimally invasive devices for the treatment of symptomatic BPH. The investigators from this study center will develop clinical trials and carry out these trails in accordance with centrally approved protocols. The study center at the Medical College of Wisconsin will enroll 180 patients in this clinical trial. The recruitment and marketing strategies outlined in the following sections will ensure this level of participation as well as maximize the center?s ability to recruit minority populations. The center has been designed to provide all the clinical, laboratory and follow-up data required in the protocol. In summary, this proposal outlines what we believe to be the outstanding credentials of the Division of Urology, the Medical College of Wisconsin to serve as a clinical center in this multi-institutional trial.

描述(由申请人提供)： 这项提案的具体目的是设立泌尿外科， 威斯康星州医学院作为临床卓越中心 名为“微创外科疗法”的多机构NIDDK试验 良性前列腺增生症的治疗联盟 临床试验中心已建成，确保了S中心的成功 达到多中心试验的长期目标。具体地说，这 建议书提供了详细信息以确定我们是否有能力满足 招募目标包括少数族裔人口。以下各节 概述该中心设计中的故障保护机制，以确保患者 资格、数据准确性和高效的数据报告。 设计这个临床中心的另外两个考虑因素 一直需要在整个过程中保持患者的依从性 登记和后续行动，以及需要与 这项多机构试验的生物统计协调中心。这些 将及时、高效、准确、专业地执行任务 确保对审判作出贡献的数据的有效性。这, 加上其他临床试验中心的类似贡献， 应该允许回答测试假设，特别是评估 下尿路微创治疗的安全性和远期疗效 肠道症状。 我们的研究中心将作为调查小组的成员参加 将进行多个随机临床试验，顺序或 同时，用于治疗有症状的微创设备 前列腺增生症。来自该研究中心的研究人员将开发临床试验和 根据中央批准的协议执行这些跟踪。这个 威斯康星医学院的研究中心将招募180名患者参加 这项临床试验。有关招聘和市场推广的策略 以下部分将确保这一级别的参与，并最大限度地 中心是什么？S有能力招收少数民族人群。该中心一直是 旨在提供所需的所有临床、实验室和后续数据 协议。总而言之，这项提案概述了我们认为 中华医科大学泌尿外科优秀学历 威斯康星州将在这项多机构试验中担任临床中心。