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 (2015) Distal ureteric stones and tamsulosin: a double-blind, placebo-controlled, randomized, multicenter trial. Annals of Emergency Medicine, 67 1: 86-95e2. doi:10.1016/j.annemergmed.2015.06.001


Author Furyk, Jeremy S.
Chu, Kevin
Banks, Colin
Greenslade, Jaimi
Keijzers, Gerben
Thom, Ogilvie
Torpie, Tom
Dux, Carl
Narula, Rajan
Title Distal ureteric stones and tamsulosin: a double-blind, placebo-controlled, randomized, multicenter trial
Journal name Annals of Emergency Medicine   Check publisher's open access policy
ISSN 1097-6760
0196-0644
Publication date 2015-01-01
Year available 2015
Sub-type Article (original research)
DOI 10.1016/j.annemergmed.2015.06.001
Open Access Status DOI
Volume 67
Issue 1
Start page 86
End page 95e2
Total pages 12
Place of publication Philadelphia, PA United States
Publisher Mosby
Language eng
Subject 2711 Emergency Medicine
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.
Formatted 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.
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2016 Collection
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