Distal ureteric stones and tamsulosin: a double-blind, placebo-controlled, randomized, multicenter trial

Furyk, Jeremy S., Chu, Kevin, Banks, Colin, Greenslade, Jaimi, Keijzers, Gerben, Thom, Ogilvie, Torpie, Tom, Dux, Carl, and Narula, Rajan (2016) Distal ureteric stones and tamsulosin: a double-blind, placebo-controlled, randomized, multicenter trial. Annals of Emergency Medicine, 67 (1). pp. 86-95.

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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.

Item ID: 42518
Item Type: Article (Research - C1)
ISSN: 1097-6760
Additional Information:

This article is published under the CC-BY-NC-ND 4.0 license.

Funders: Queensland Emergency Medicine Research Foundation (QEMRF)
Date Deposited: 10 Feb 2016 07:31
FoR Codes: 11 MEDICAL AND HEALTH SCIENCES > 1103 Clinical Sciences > 110312 Nephrology and Urology @ 100%
SEO Codes: 92 HEALTH > 9201 Clinical Health (Organs, Diseases and Abnormal Conditions) > 920119 Urogenital System and Disorders @ 100%
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