INTRAPROSTATIC INJECTOF BOTULINUMTOXIN FOR MGMT OF BENIGN PROSTATIC HYPERPLASIA

前列腺内注射肉毒杆菌毒素治疗良性前列腺增生

• 批准号: 7604406
• 负责人: AL BARQAWI
• 金额: $ 1.21万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-07-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604406
• 关键词: Adverse event; Age; Benign Prostatic Hypertrophy; Botox; Botulinum Toxins; Computer Retrieval of Information on Scientific Projects Database; Dose; Enrollment; Funding; Grant; Injection of therapeutic agent; Institution; Measures; Monitor; Patients; Phase; Phase I Clinical Trials; Prostate; Reporting; Research; Research Design; Research Personnel; Resources; Safety; Sexual Health; Source; Symptoms; United States National Institutes of Health; follow-up; inclusion criteria; men; urinary

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is an investigator initiated Phase I study of the safety and Efficasy of Botulinum toxin (Botox¿) injection into the prostate in patients who have obstructive lower urinary symptoms due to Benign Prostatic Hyperplasia. A phase I design of this study refers to an escalating dose increase of Botulinum toxin to measure the maximal tolerated doze. 24 men over the age of 50, who match the inclusion criteria, will be enrolled prospectively in the study with a median follow up of 12 months. The safety will be assessed by close follow up on 2 weekly interval and recording any reported adverse events. The efficacy will be assessed by monitoring changes in urinary symptoms and sexual health parameters. Changes in Uroflowmetry and prostate volume will also be recorded

该副本是使用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这是调查员的机构。 这是研究者对肉毒杆菌毒素（肉毒杆菌素（肉毒杆菌）（肉毒杆菌毒素）注射到前列腺的安全性和有效性的开始，这是由于良性前列腺增生性增生而导致的阻塞性较低泌尿症状的患者。这项研究的第一阶段设计是指肉毒杆菌毒素的剂量增加，以测量最大耐受性的打ze。符合纳入标准的50岁以上的24名男性将被前瞻性地参与研究，中位随访时间为12个月。安全将通过2个每周间隔进行仔细随访，并记录任何报告的不良事件。该效率将通过监测尿症状和性健康参数的变化来评估。还将记录尿流仪和前列腺体积的变化