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|Surgery - Urology|
|Family Medicine (FM)/General Practice (GP)|
|General Internal Medicine-Primary Care(US)|
Importance: Urinary stone disease is a common presentation in the emergency department, and a-adrenergic receptor blockers, such as tamsulosin, are commonly used to facilitate stone passage.
Objective: To determine if tamsulosin promotes the passage of urinary stones within 28 days among emergency department patients.
Design, Setting, and Participants: We conducted a double-blind, placebo-controlled clinical trial from 2008 to 2009 (first phase) and then from 2012 to 2016 (second phase). Participants were followed for 90 days. The first phase was conducted at a single US emergency department; the second phase was conducted at 6 US emergency departments. Adult patients were eligible to participate if they presented with a symptomatic urinary stone in the ureter less than 9 mm in diameter, as demonstrated on computed tomography.
Interventions: Participants were randomized to treatment with either tamsulosin, 0.4 mg, or matching placebo daily for 28 days.
Main Outcomes and Measures: The primary outcome was stone passage based on visualization or capture by the study participant by day 28. Secondary outcomes included crossover to open-label tamsulosin, time to stone passage, return to work, use of analgesic medication, hospitalization, surgical intervention, and repeated emergency department visit for urinary stones.
Results: The mean age of 512 participants randomized to tamsulosin or placebo was 40.6 years (range, 18-74 years), 139 (27.1%) were female, and 110 (22.8%) were nonwhite. The mean (SD) diameter of the urinary stones was 3.8 (1.4) mm. Four hundred ninety-seven patients were evaluated for the primary outcome. Stone passage rates were 50% in the tamsulosin group and 47% in the placebo group (relative risk, 1.05; 95.8% CI, 0.87-1.27; P = .60), a nonsignificant difference. None of the secondary outcomes were significantly different. All analyses were performed according to the intention-to-treat principle, although patients lost to follow-up before stone passage were excluded from the analysis of final outcome.
Conclusions and Relevance: Tamsulosin did not significantly increase the stone passage rate compared with placebo. Our findings do not support the use of tamsulosin for symptomatic urinary stones smaller than 9 mm. Guidelines for medical expulsive therapy for urinary stones may need to be revised.
Trial Registration: ClinicalTrials.gov Identifier: NCT00382265.
This is a well performed study but is under-powered, particularly for determining the effect on larger stones. Most patients had stones <5 mm, located distally or at the UVJ. Small distal stones are less likely to benefit from medical expulsive therapy; however, the spontaneous passage rate in this study was surprisingly low with either placebo or tamsulosin. Ye`s well done study of nearly 3500 patients with 4-7 mm stones (all distal), found that tamsulosin was beneficial for 6-7mm stones (n=2180), but not for 4-5 mm stones (n=1116). Although that study was not exclusively ED patients, it is likely as close to the "truth" as we are going to get for this question. What size proximal stone might benefit is still unclear.
As a surgeon, I found this a good example of a well designed randomized study assessing the immediate impact of an intervention. The study was well planned to meet its objectives.
The investigators found no difference in kidney stone passage for patients given tamsulosin or placebo among patients with kidney stones under nine millimeters. Surprisingly, 1099 patients of the 1899 patients assessed for eligibility were excluded because they didn`t meet the inclusion criteria (age >=18 years, evidence of ureterolithiasis on CT with confident diagnosis, willingness to participate and proceed with standard outpatient management and had a telephone for follow-up). The accompanying editorial describes a separate trial in China suggesting a benefit for patients with a stone > 5 millimeters in size, but this trial had only 43 patients with a stone that large. The only significant difference in adverse event rates was abnormal ejaculation among males (18.2% vs 7.4%). I don`t think this evidence is strong enough to change existing treatment patterns for providers managing patients with this condition.
The study did not find that tamsulosin increased stone passage for stones >5 mm. The accompanying editorial indicates that other studies have shown benefit in those with stones >5mm.
Statistical and clinical significance is highlighted by these results.