title: Design and challenges of a randomized clinical trial of medical expulsive therapy (tamsulosin) for urolithiasis in the emergency department.
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.
authors.affiliation: 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: pam_b@bsc.gwu.edu.
authors.forename: Pamela K
authors.initials: PK
authors.lastname: Burrows
authors.affiliation: Department of Emergency Medicine, Thomas Jefferson University Hospital, 1020 Sansom Street, Philadelphia, PA 19107, United States.
authors.forename: Judd E
authors.initials: JE
authors.lastname: Hollander
authors.affiliation: Department of Emergency Medicine, University of Pittsburgh, Suite 400A Iroquois Building, 3600 Forbes Avenue, Pittsburgh, PA, 15261, United States.
authors.forename: Allan B
authors.initials: AB
authors.lastname: Wolfson
authors.affiliation: Department of Emergency Medicine, University of Alabama at Birmingham, 619 19th Street South, Birmingham, AL 35249, United States.
authors.forename: Michael C
authors.initials: MC
authors.lastname: Kurz
authors.affiliation: Department of Emergency Medicine, George Washington University Medical Faculty Associates, 2120 L Street NW, Washington, DC 20037, United States.
authors.forename: Lorna
authors.initials: L
authors.lastname: Richards
authors.affiliation: Department of Emergency Medicine, University of Pittsburgh, Suite 400A Iroquois Building, 3600 Forbes Avenue, Pittsburgh, PA, 15261, United States.
authors.forename: Sara
authors.initials: S
authors.lastname: DiFiore
authors.affiliation: Department of Emergency Medicine, Thomas Jefferson University Hospital, 1020 Sansom Street, Philadelphia, PA 19107, United States.
authors.forename: Phillip
authors.initials: P
authors.lastname: Watts
authors.affiliation: Department of Emergency Medicine, University of Alabama at Birmingham, 619 19th Street South, Birmingham, AL 35249, United States.
authors.forename: Nivedita
authors.initials: N
authors.lastname: Patkar
authors.affiliation: Department of Emergency Medicine, George Washington University Medical Faculty Associates, 2120 L Street NW, Washington, DC 20037, United States.
authors.forename: Jeremy
authors.initials: J
authors.lastname: Brown
authors.affiliation: Department of Emergency Medicine, University of Pittsburgh, Suite 400A Iroquois Building, 3600 Forbes Avenue, Pittsburgh, PA, 15261, United States.
authors.forename: Stephen
authors.initials: S
authors.lastname: Jackman
authors.affiliation: National Institute of Diabetes and Digestive and Kidney Diseases, Division of Kidney, Urologic and Hematologic Diseases, 6707 Democracy Boulevard, Bethesda, MD 20892, United States.
authors.forename: Ziya
authors.initials: Z
authors.lastname: Kirkali
authors.affiliation: National Institute of Diabetes and Digestive and Kidney Diseases, Division of Kidney, Urologic and Hematologic Diseases, 6707 Democracy Boulevard, Bethesda, MD 20892, United States.
authors.forename: John W
authors.initials: JW
authors.lastname: Kusek
authors.affiliation: Department of Emergency Medicine, George Washington University Medical Faculty Associates, 2120 L Street NW, Washington, DC 20037, United States.
authors.forename: Chloe
authors.initials: C
authors.lastname: Michel
authors.affiliation: Department of Emergency Medicine, George Washington University Medical Faculty Associates, 2120 L Street NW, Washington, DC 20037, United States.
authors.forename: Andrew C
authors.initials: AC
authors.lastname: Meltzer
mesh_terms: D000700:Analgesics / Q000627:therapeutic use; D004311:Double-Blind Method; D004636:Emergency Service, Hospital; D006801:Humans; D059408:Pain Management; D013449:Sulfonamides / Q000627:therapeutic use*; D000077409:Tamsulosin; D016896:Treatment Outcome; D052878:Urolithiasis / Q000188:drug therapy*; D064804:Urological Agents / Q000627:therapeutic use*
chemical_list: D000700:Analgesics; D013449:Sulfonamides; D064804:Urological Agents; D000077409:Tamsulosin
keywords: Alpha-blocker; Emergency department; Kidney stones; Medical expulsive therapy; Urinary stone disease; Urolithiasis