Design and challenges of a randomized clinical trial of medical expulsive therapy (tamsulosin) for urolithiasis in the emergency department
Pamela K Burrows, Judd E Hollander, Allan B Wolfson, Michael C Kurz, Lorna Richards, Sara DiFiore, Phillip Watts, Nivedita Patkar, Jeremy Brown, Stephen Jackman, Ziya Kirkali, John W Kusek, Chloe Michel, Andrew C Meltzer, STONE Study Investigators, Pamela K Burrows, Judd E Hollander, Allan B Wolfson, Michael C Kurz, Lorna Richards, Sara DiFiore, Phillip Watts, Nivedita Patkar, Jeremy Brown, Stephen Jackman, Ziya Kirkali, John W Kusek, Chloe Michel, Andrew C Meltzer, STONE Study Investigators
Abstract
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.
Trial registration: ClinicalTrials.gov NCT00382265.
Keywords: Alpha-blocker; Emergency department; Kidney stones; Medical expulsive therapy; Urinary stone disease; Urolithiasis.
Copyright © 2016 Elsevier Inc. All rights reserved.
Source: PubMed