Urodynamic and Multiethnic Variability of Men Treated b*

接受 b* 治疗的男性的尿动力学和多种族变异性

• 批准号: 6659803
• 负责人: STEVEN A KAPLAN
• 金额: $ 39.26万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 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 2006-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6659803
• 关键词: African American; Hispanic Americans; benign prostate hyperplasia; caucasian American; clinical trials; cooperative study; human subject; human therapy evaluation; hyperthermia therapy; laser therapy; male; outcomes research; patient oriented research; prognosis; racial /ethnic difference; urinary tract motility /pressure; urinary tract obstruction; urinary tract surgery; urination

DESCRIPTION (provided by applicant): Benign prostatic hyperplasia (BPH) is the most common affliction of men over the age of 50. Despite numerous innovations in therapy for BPH including medical and minimally invasive surgical therapies (MIST), transurethral resection of the prostate (TURP) remains the most effective. In part, the shortcomings of MIST have been the lack of uniform baseline study entry criteria, poor elucidation of baseline criteria aid in therapeutic success and paucity of long-term data. Furthermore, there have been no studies that have attempted to stratify response to therapy based on ethnic variability. Recent data suggests that there may be varying distribution of symptoms, objective diagnoses, and functional / morphologic aspects of the prostate among different ethnic groups. Do minimally invasive alternative surgical therapies result in alternating levels of success among different ethnic groups? The Prostate Center at the New York Presbyterian Medical Center evaluates and treats an ethnically diverse group of more than 1,000 men per year with lower urinary tract symptoms secondary to BPH. In addition it has access to and currently employs all FDA approved MIST procedures, including transurethral microwave thermotherapy, TUNA, interstitial laser, water induced thermotherapy, holmium laser prostatectomy and electrovaporization. We propose to examine the role of MISTs designed to treat BPH a multi - ethnic group. The goals of this clinical trial are to determine the urodynamic changes in bladder function and outlet obstruction in patients with BPH treated by MIST. Parameters to be analyzed include peak detrusor pressure during voiding, detrusor pressure during maximal flow, Shafer resistance curves, Abrams - Griffiths contractility index and detrusor contraction duration. These parameters will be assessed to determine prognostic significance and correlated with long term improvement as determined by changes in the American Urologic Association Symptom Score (AUASx), uroflow and post void residual urine. Specifically, this study aims to evaluate in a highly diverse multi - ethnic population: 1. Urodynamic contractility and resistance parameters which change significantly after MIST 2. Baseline urodynamic parameters which may predict improved outcome after MIST 3. The success of various types of MIST in treating BPH in African - American, Hispanic and Caucasian men.

描述（由申请人提供）： 良性前列腺增生（BPH）是男性最常见的疾病 50 岁。尽管 BPH 治疗方法有许多创新，包括 药物和微创手术治疗 (MIST)、经尿道 前列腺切除术（TURP）仍然是最有效的。部分地， MIST 的缺点是缺乏统一的基线研究条目 标准、基线标准的阐明不充分有助于治疗的成功和 缺乏长期数据。此外，目前还没有研究表明 试图根据种族差异对治疗的反应进行分层。最近的 数据表明，症状的分布可能有所不同，客观 不同人群中前列腺的诊断和功能/形态学方面 族裔群体。微创替代手术疗法会导致 不同种族群体之间的成功水平交替吗？ 纽约长老会医学中心的前列腺中心评估并 每年为超过 1,000 名不同种族的男性提供较低的治疗 继发于 BPH 的尿路症状。此外，它还可以访问和 目前采用 FDA 批准的所有 MIST 程序，包括经尿道 微波热疗、TUNA、间质激光、水诱导热疗、 钬激光前列腺切除术和电汽化术。我们建议审查 旨在治疗多种族 BPH 的 MIST 的作用。本次活动的目标 临床试验的目的是确定膀胱功能的尿动力学变化和 MIST 治疗 BPH 患者的出口梗阻。参数为 分析的内容包括排尿期间的峰值逼尿肌压力、逼尿肌压力 最大流量期间，Shafer 阻力曲线，Abrams - Griffiths 收缩力 指数和逼尿肌收缩持续时间。这些参数将被评估为 确定预后意义并与长期改善相关 由美国泌尿外科协会症状评分的变化决定 (AUASx)、尿流量和排尿后残余尿。 具体来说，本研究旨在评估高度多样化的多种族群体。 人口： 1.尿动力收缩力和阻力参数的变化 MIST 后显着 2. 基线尿动力学参数可预测 MIST 后改善的结果 3. 各种类型的MIST在非洲裔美国人中治疗BPH的成功， 西班牙裔和白人男性。