Tamsulosin for Ureteral Stones in the Emergency Department: A Randomized, Controlled Trial
Presented at the 2007 American College of Emergency Physicians Research Forum, October 2007, Seattle, WA.
Received 9 June 2008; received in revised form 4 November 2008 and 26 November 2008; accepted 19 December 2008. published online 06 February 2009.
Study objective
The α-adrenergic antagonist tamsulosin hydrochloride has become an increasingly common adjunct in the treatment of ureteral calculi; however, its efficacy in a general emergency department (ED) population has not been investigated.
Methods
We conducted a randomized, controlled trial of adult ED patients with distal ureteral calculi diagnosed by computed tomography scan. Patients were randomized to receive either a 10-day course of ibuprofen and oxycodone plus tamsulosin or ibuprofen and oxycodone alone. The primary outcome measure was successful spontaneous ureteral stone expulsion at 14 days. Secondary outcomes included time to stone passage, self-reported pain scores, number of colicky pain episodes, unscheduled return ED/primary care visits, number of days of missed work/usual function, amount of analgesic used, and adverse events.
Results
Eighty subjects were enrolled in the study, with 77 completing the trial. Mean stone size was 3.6 mm (95% confidence interval [CI] 3.4 to 3.9). Successful spontaneous stone expulsion at 14 days was similar between the groups, with 27 (77.1%) subjects in the tamsulosin group and 24 (64.9%) subjects in the standard therapy group reporting spontaneous stone passage, a difference of 12% (95% CI –8.4% to 32.8%). At 2-, 5-, and 14-day follow-up, there were no clinically important (or statistically significant) differences between the groups for any secondary outcome measure. No adverse events were reported in either group.
Conclusion
In this cohort of adult ED patients with distal ureteral calculi, treatment with tamsulosin did not substantially improve any of the studied outcome measures compared with treatment with ibuprofen and oxycodone alone.
aWilford Hall Medical Center, 59th Medical Wing, Lackland Air Force Base, San Antonio, TX
bMaine Medical Center, Department of Emergency Medicine, Portland, ME
Address for correspondence: Tania D. Strout, RN, BSN, MS, Maine Medical Center, Department of Emergency Medicine, 22 Bramhall Street, Portland, ME 04102; 207-662-7049, fax 207-662-7054
Author contributions: RMF, TDS, and ADP conceived the study and designed the trial. JNW and TDS acquired the data. RMF and TDS analyzed the data and interpreted the results. RMF and TDS drafted the article, whereas all authors revised it for intellectual content. TDS provided statistical expertise. All authors take responsibility for the paper as a whole.
Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article that might create any potential conflict of interest. See the Manuscript Submission Agreement in this issue for examples of specific conflicts covered by this statement. This study was funded by an academic grant from the Maine Medical Center Mentored Research Committee.
Reprints not available from authors.
Publication date: Available online February 5, 2009.