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Ann Emerg Med. 2016 Jan;67(1):86-95.e2. doi: 10.1016/j.annemergmed.2015.06.001. Epub 2015 Jul 17.

Distal Ureteric Stones and Tamsulosin: A Double-Blind, Placebo-Controlled, Randomized, Multicenter Trial.

Author information

1
Department of Emergency Medicine, The Townsville Hospital, Townsville, Queensland, Australia; School of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia; School of Medicine, University of Queensland, Brisbane, Queensland, Australia. Electronic address: Jeremy.Furyk@health.qld.gov.au.
2
School of Medicine, University of Queensland, Brisbane, Queensland, Australia; Department of Emergency Medicine, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.
3
Department of Emergency Medicine, The Townsville Hospital, Townsville, Queensland, Australia.
4
Department of Emergency Medicine, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.
5
Gold Coast Health Service District (Gold Coast University Hospital and Robina Hospital, Griffith University, Bond University), Gold Coast, Queensland, Australia.
6
School of Medicine, University of Queensland, Brisbane, Queensland, Australia; Department of Emergency Medicine, Nambour General Hospital, Nambour, Queensland, Australia.
7
Department of Emergency Medicine, Princess Alexandra Hospital, Brisbane, Queensland, Australia.
8
Department of Surgery, The Townsville Hospital, Townsville, Queensland, Australia; School of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia.

Abstract

STUDY OBJECTIVE:

We assess the efficacy and safety of tamsulosin compared with placebo as medical expulsive therapy in patients with distal ureteric stones less than or equal to 10 mm in diameter.

METHODS:

This was a randomized, double-blind, placebo-controlled, multicenter trial of adult participants with calculus on computed tomography (CT). Patients were allocated to 0.4 mg of tamsulosin or placebo daily for 28 days. The primary outcomes were stone expulsion on CT at 28 days and time to stone expulsion.

RESULTS:

There were 403 patients randomized, 81.4% were men, and the median age was 46 years. The median stone size was 4.0 mm in the tamsulosin group and 3.7 mm in the placebo group. Of 316 patients who received CT at 28 days, stone passage occurred in 140 of 161 (87.0%) in the tamsulosin group and 127 of 155 (81.9%) with placebo, a difference of 5.0% (95% confidence interval -3.0% to 13.0%). In a prespecified subgroup analysis of large stones (5 to 10 mm), 30 of 36 (83.3%) tamsulosin participants had stone passage compared with 25 of 41 (61.0%) with placebo, a difference of 22.4% (95% confidence interval 3.1% to 41.6%) and number needed to treat of 4.5. There was no difference in urologic interventions, time to self-reported stone passage, pain, or analgesia requirements. Adverse events were generally mild and did not differ between groups.

CONCLUSION:

We found no benefit overall of 0.4 mg of tamsulosin daily for patients with distal ureteric calculi less than or equal to 10 mm in terms of spontaneous passage, time to stone passage, pain, or analgesia requirements. In the subgroup with large stones (5 to 10 mm), tamsulosin did increase passage and should be considered.

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