Distal Ureteric Stones and Tamsulosin: A double-blind, placebo-controlled, randomized, multicenter trial

Jeremy S. Furyk, Kevin Chu, Colin Banks, Jaimi H. Greenslade, Gerben Keijzers, Ogilvie Thom, Tom Torpie, Carl Dux, Rajan Narula

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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.

Original languageEnglish
Pages (from-to)86-95e2
JournalAnnals of Emergency Medicine
Volume67
Issue number1
DOIs
Publication statusPublished - 1 Jan 2016

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tamsulosin
Multicenter Studies
Placebos
Tomography
Calculi
Analgesia
Confidence Intervals
Pain
Numbers Needed To Treat

Cite this

Furyk, Jeremy S. ; Chu, Kevin ; Banks, Colin ; Greenslade, Jaimi H. ; Keijzers, Gerben ; Thom, Ogilvie ; Torpie, Tom ; Dux, Carl ; Narula, Rajan. / Distal Ureteric Stones and Tamsulosin : A double-blind, placebo-controlled, randomized, multicenter trial. In: Annals of Emergency Medicine. 2016 ; Vol. 67, No. 1. pp. 86-95e2.
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title = "Distal Ureteric Stones and Tamsulosin: A double-blind, placebo-controlled, randomized, multicenter trial",
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.",
author = "Furyk, {Jeremy S.} and Kevin Chu and Colin Banks and Greenslade, {Jaimi H.} and Gerben Keijzers and Ogilvie Thom and Tom Torpie and Carl Dux and Rajan Narula",
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Furyk, JS, Chu, K, Banks, C, Greenslade, JH, Keijzers, G, Thom, O, Torpie, T, Dux, C & Narula, R 2016, 'Distal Ureteric Stones and Tamsulosin: A double-blind, placebo-controlled, randomized, multicenter trial' Annals of Emergency Medicine, vol. 67, no. 1, pp. 86-95e2. https://doi.org/10.1016/j.annemergmed.2015.06.001

Distal Ureteric Stones and Tamsulosin : A double-blind, placebo-controlled, randomized, multicenter trial. / Furyk, Jeremy S.; Chu, Kevin; Banks, Colin; Greenslade, Jaimi H.; Keijzers, Gerben; Thom, Ogilvie; Torpie, Tom; Dux, Carl; Narula, Rajan.

In: Annals of Emergency Medicine, Vol. 67, No. 1, 01.01.2016, p. 86-95e2.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Distal Ureteric Stones and Tamsulosin

T2 - A double-blind, placebo-controlled, randomized, multicenter trial

AU - Furyk, Jeremy S.

AU - Chu, Kevin

AU - Banks, Colin

AU - Greenslade, Jaimi H.

AU - Keijzers, Gerben

AU - Thom, Ogilvie

AU - Torpie, Tom

AU - Dux, Carl

AU - Narula, Rajan

PY - 2016/1/1

Y1 - 2016/1/1

N2 - 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.

AB - 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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U2 - 10.1016/j.annemergmed.2015.06.001

DO - 10.1016/j.annemergmed.2015.06.001

M3 - Article

VL - 67

SP - 86-95e2

JO - Journal of the American College of Emergency Physicians

JF - Journal of the American College of Emergency Physicians

SN - 0196-0644

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