Multi-Center Study of Tamsulosin for Ureteral Stones in the Emergency Department

坦索罗辛治疗急诊输尿管结石的多中心研究

• 批准号: 8348145
• 负责人: JEREMY BROWN
• 金额: $ 107.17万
• 依托单位: GEORGE WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-01 至 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8348145
• 关键词: Absence of pain sensation; Accident and Emergency department; Acute; Affect; Blinded; Calculi; Caring; Chi-Square Tests; Clinic; Clinical; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Consent; Cost Savings; Data Analyses; Diagnosis; Double-Blind Method; Emergency Situation; Employment; Enrollment; Funding; Goals; Health Benefit; Intervention; Kidney Calculi; Length; Lithotripsy; Medical; Monitor; Multi-Institutional Clinical Trial; Narcotics; National Institute of Diabetes and Digestive and Kidney Diseases; Operative Surgical Procedures; Outcome; Outpatients; Pain; Pain-Free; Patients; Pennsylvania; Pharmaceutical Preparations; Phase; Physicians; Pilot Projects; Placebos; Population; Prostate; Randomized; Recovery; Recruitment Activity; Running; Sample Size; Side; Site; Smooth Muscle; Subgroup; Surgical complication; Testing; Therapeutic; Time; United States; Universities; University Hospitals; Ureter; Urologist; Visit; Washington; Work; arm; cost; double-blind placebo controlled trial; follow-up; placebo controlled study; primary outcome; response; tamsulosin; urolithiasis; urologic

DESCRIPTION (provided by applicant): This project will determine if tamsulosin is useful in patients with a kidney stone. Tamsulosin is used for patients with an enlarged prostate gland, but it has other effects, including relaxing the smooth muscle of the ureters. It is thought that through this mechanism tamsulosin may aid patients with kidney stones that are located in the ureters. This study builds on an earlier placebo controlled double blind trial performed at the George Washington University Hospital that successfully enrolled 109 patients with kidney stones. A further 391 patients will be recruited to that a total of 500 patients will be in the stuy. The sites for the study will be the emergency departments at The George Washington University, the Hospital of University of Pennsylvania and University of Pittsburgh. The primary outcome will be the number of patients who have passed the kidney stone by 30 days after diagnosis. We will also determine if the drug causes other benefits such as reduced pain, less time off work, and a reduced need for surgical intervention. PUBLIC HEALTH RELEVANCE: Kidney stones affect about 10% of the population and result in over one million visits every year to the emergency department. Although many stones pass, all cause considerable pain and many require follow up visits to a urologist and surgical intervention. If tamsulosin is shown to increase the rate of stone passage and decrease surgical complications, it will be a major health benefit.

描述（由申请人提供）：该项目将确定坦索罗辛对肾结石患者是否有用。坦索罗辛用于治疗前列腺肥大的患者，但它还有其他作用，包括放松输尿管平滑肌。据认为，通过这种机制，坦索罗辛可以帮助患有输尿管肾结石的患者。这项研究建立在乔治华盛顿大学医院早期进行的一项安慰剂对照双盲试验的基础上，该试验成功招募了 109 名肾结石患者。另外还将招募 391 名患者，总共 500 名患者将参与该研究。研究地点将是乔治华盛顿大学、宾夕法尼亚大学医院和匹兹堡大学的急诊科。主要结果是诊断后 30 天排出肾结石的患者人数。我们还将确定该药物是否会带来其他好处，例如减轻疼痛、减少下班时间以及减少手术干预的需要。 公共健康相关性：肾结石影响着大约 10% 的人口，每年有超过 100 万人到急诊室就诊。尽管许多结石会排出，但都会引起相当大的疼痛，并且许多结石需要泌尿科医生的随访和手术干预。如果坦索罗辛被证明可以增加结石排出率并减少手术并发症，这将是一个重大的健康益处。