Meltzer AC, et al. - Researchers ascertained whether tamsulosin promotes the passage of urinary stones within 28 days among Emergency Department patients. Compared with placebo, tamsulosin did not significantly increase the stone passage rate. The use of tamsulosin for symptomatic urinary stones smaller than 9 mm was not recommended. They suggested that guidelines for medical expulsive therapy for urinary stones might need to be revised.

Methods

• From 2008 to 2009 (first phase) and then from 2012 to 2016 (second phase), a double-blind, placebo-controlled clinical trial was conducted.
• Participants in the study were were followed for 90 days.
• At a single US Emergency Department, the first phase was conducted.
• At 6 US Emergency Departments, the second phase was conducted.
• Adult subjects were eligible to take part if they presented with a symptomatic urinary stone in the ureter less than 9 mm in diameter, as revealed on computed tomography.
• Study participants were randomized to treatment with either tamsulosin, 0.4 mg, or matching placebo daily for 28 days.
• Stone passage based on visualization or capture by the study participant by day 28 was the primary outcome.
• 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 were the included secondary outcomes.

Results

• According to the findings obtained, the mean age of 512 members randomized to tamsulosin or placebo was 40.6 years (range, 18-74 years), 139 (27.1%) were female, and 110 (22.8%) were nonwhite.
• It was observed that the mean (SD) diameter of the urinary stones was 3.8 (1.4) mm.
• It was noted that 497 patients were evaluated for the primary outcome.
• Results revealed that 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 in this analysis.
• The study results showed that all analyses were performed according to the intention-to-treat principle, although subjects lost to follow-up before stone passage were excluded from the analysis of final outcome.