Design and challenges of a randomized clinical trial of medical expulsive therapy (tamsulosin) for urolithiasis in the emergency department

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• 作者：Pamela K Burrows^a ; ^{pam_b@bsc.gwu.edu} ; Judd E Hollander^b ; Allan B Wolfson^c ; Michael C Kurz^d ; Lorna Richards^e ; Sara DiFiore^c ; Phillip Watts^b ; Nivedita Patkar^d ; Jeremy Brown^e ; ¹ ; Stephen Jackman^c ; Ziya Kirkali^f ; John W Kusek^f ; Chloe Michel^e ; Andrew C Meltzer^e ; for the STONE Study Investigators
• 关键词：CT ; computed tomography ; DSMB ; Data and Safety Monitoring Board ; ED ; emergency department ; MET ; medical expulsive therapy ; NIDDK ; National Institute of Diabetes and Digestive and Kidney Diseases ; USD ; urinary stone disease
• 刊名：Contemporary Clinical Trials
• 出版年：2017
• 出版时间：January 2017
• 年：2017
• 卷：52
• 期：Complete
• 页码：91-94
• 全文大小：191 K
• 卷排序：52

文摘

Urolithiasis or urinary stone disease has been estimated to affect about 1 in 11 Americans. Patients with urinary stone disease commonly present to the emergency department for management of their acute pain. In addition to providing analgesia, administration of drug (medical expulsive therapy) is often prescribed to assist passage of the urinary stone. In this methodology paper, we describe the design of a prospective, multi-center, randomized, double-blind placebo controlled clinical trial of the alpha-adrenergic blocker, tamsulosin, to evaluate its effectiveness as medical expulsive therapy. In addition, we describe the unique challenges of conducting a trial of this type within the setting of the emergency department.