STONE
Trial question
What is the effect of tamsulosin on passage of symptomatic ureteral stones < 9 mm in diameter?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
27.0% female
73.0% male
N = 512
512 patients (139 female, 373 male).
Inclusion criteria: adult patients with a symptomatic urinary stone in the ureter < 9 mm in diameter, as demonstrated on CT.
Key exclusion criteria: taking exclusionary medications, prior kidney/ureter surgery, admitted to hospital, stone ≥ 9 mm, bladder stone, concurrent UTI.
Interventions
N=267 tamsulosin (0.4 mg tablet daily for 28 days).
N=245 placebo (identical capsule daily for 28 days).
Primary outcome
Rate of urinary stone passage at the end of 28-day treatment period
49.6%
47.3%
49.6 %
37.2 %
24.8 %
12.4 %
0.0 %
Tamsulosin
Placebo
No significant
difference ↔
No significant difference in the rate of urinary stone passage at the end of 28-day treatment period (49.6% vs. 47.3%; RR 1.05, 95% CI 0.87 to 1.27).
Secondary outcomes
No significant difference in stone passage on follow-up CT (83.6% vs. 77.6%; RR 1.08, 95% CI 0.95 to 1.22).
Safety outcomes
No significant difference in adverse events.
Conclusion
In adult patients with a symptomatic urinary stone in the ureter < 9 mm in diameter, as demonstrated on CT, tamsulosin was not superior to placebo with respect to the rate of urinary stone passage at the end of 28-day treatment period.
Reference
Meltzer AC, Burrows PK, Wolfson AB et al. Effect of Tamsulosin on Passage of Symptomatic Ureteral Stones: A Randomized Clinical Trial. JAMA Intern Med. 2018 Aug 1;178(8):1051-1057.
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