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.
Contemporary clinical trials. 2016 Nov 23 [Epub ahead of print]
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
The George Washington University Biostatistics Center, George Washington University Milken Institute School of Public Health, 6110 Executive Boulevard, Rockville, MD 20852, United States. Electronic address: ., Department of Emergency Medicine, Thomas Jefferson University Hospital, 1020 Sansom Street, Philadelphia, PA 19107, United States., Department of Emergency Medicine, University of Pittsburgh, Suite 400A Iroquois Building, 3600 Forbes Avenue, Pittsburgh, PA, 15261, United States., Department of Emergency Medicine, University of Alabama at Birmingham, 619 19th Street South, Birmingham, AL 35249, United States., Department of Emergency Medicine, George Washington University Medical Faculty Associates, 2120 L Street NW, Washington, DC 20037, United States., National Institute of Diabetes and Digestive and Kidney Diseases, Division of Kidney, Urologic and Hematologic Diseases, 6707 Democracy Boulevard, Bethesda, MD 20892, United States.