Plenary: Next Frontier, Sunday
Plenary: Next Frontier
Presentation Authors: Andrew C. Meltzer*, Washington, DC, Judd E. Hollander, Philadelphia, PA, Allan B. Wolfson, Pittsburgh, PA, Michael C. Kurz, Birmingham, AL, Stephen V. Jackman, Pittsburgh, PA, Ziya Kirkali, John W. Kusek, Bethesda, MD, Pamela K. Burrows, Rockville, MD
Introduction: Urinary stone disease (USD) is common, increasing with many patients first presenting to the emergency department (ED). Use of alpha-adrenergic receptor antagonists (alpha-blockers) has been advocated to promote passage of urinary stones. We conducted a multi-center, double-blind, placebo-controlled clinical trial of the alpha-blocker tamsulosin in ED for ureteral stones less than 9 mm in diameter.
Methods: Patients presenting to five EDs with USD confirmed by non-contrast spiral computed tomography (CT) were randomized equally to receive tamsulosin 0.4 mg daily or placebo. The primary outcome was stone passage, determined by either visualization or capture by the study participant, within 28 days of randomization. The primary outcome analysis compared binomial proportions for each of the two treatment groups using a chi-square test statistic. Secondary outcomes were confirmation of stone passage on follow-up CT in a subgroup (n=237), need for surgical intervention, crossover to open-label tamsulosin, and days of work lost.
Results: We randomized 512 participants. The mean ± standard deviation (SD) age was 40.6 ± 13.3 years. Symptomatic urinary stones were identified in the following locations: 45% ureterovesical junction, 24% distal ureter, 10% mid-ureter, 17% proximal ureter and 3% renal pelvis. The mean ± SD diameter of the symptomatic stone was 3.8 ± 1.4 mm (range, 1 mm to 8 mm). The proportion of study participants who had passed a stone by day 28 (outcome determined in 97% of those randomized) was 52% in the tamsulosin group and 49% in the placebo group (relative risk 1.07, 95% confidence interval 0.90-1.28; p=0.447).
Conclusions: The proportion of patients who had passed their urinary stones at day 28 did not differ significantly between tamsulosin and placebo. The trial was not designed to detect stone passage according to stone location. Our results do not support the use of this drug to promote passage of urinary stones less than 9 mm in diameter.
Source Of Funding: The STONE Study is supported by cooperative agreement U01 DK096037 from the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health (Pilot Study RO1 DK071603, Planning Grant U34 DK090957). The study is registered at clinicaltrials.gov (NCT00382265).
GEORGE WASHINGTON UNIVERSITY
Andrew C. Meltzer MD MS is an Associate Professor of Emergency Medicine at George Washington University and a board-certified emergency physician who focuses on the use of bedside diagnostics and therapeutics to identify, understand and care for patients with emergency urologic and gastrointestinal conditions as well as broad applications of acute care medicine. In addition to his laboratory, clinical, and research leadership and advocacy, Dr. Meltzer has authored over 50 peer-reviewed articles, peer-reviewed presentations and book chapters, and is an active lecturer and educator. Dr. Meltzer attended medical school at the SUNY Downstate School of Medicine in New York City, completed his residency and fellowship training in emergency medicine and clinical research at the University of Maryland Department of Emergency Medicine and Shock Trauma Center, and serves as Director, Division of Clinical Research in the Center for Healthcare Innovation and Policy Research at the George Washington University School of Medicine.