Recent large high-quality trials have questioned the clinical effectiveness of medical
expulsive therapy using tamsulosin for ureteral stones.
To evaluate the efficacy and safety of tamsulosin for distal ureteral stones compared
Design, setting, and participants
We conducted a double-blind, placebo-controlled study of 3296 patients with distal
ureteral stones, across 30 centers, to evaluate the efficacy and safety of tamsulosin.
Participants were randomly assigned (1:1) into tamsulosin (0.4 mg) or placebo groups for 4 wk.
Outcome measurements and statistical analysis
The primary end point of analysis was the overall stone expulsion rate, defined as
stone expulsion, confirmed by negative findings on computed tomography, over a 28-d
surveillance period. Secondary end points included time to stone expulsion, use of
analgesics, and incidence of adverse events.
Results and limitations
Among 3450 patients randomized between September 1, 2011, and August 31, 2013, 3296
(96%) were included in the primary analysis. Tamsulosin benefits from a higher stone
expulsion rate than the placebo (86% vs 79%; p < 0.001) for distal ureteral stones. Subgroup analysis identified a specific benefit
of tamsulosin for the treatment of large distal ureteral stones (>5 mm). Considering the secondary end points, tamsulosin-treated patients reported a
shorter time to expulsion (p < 0.001), required lower use of analgesics compared with placebo (p < 0.001), and significantly relieved renal colic (p < 0.001). No differences in the incidence of adverse events were identified between
the two groups.
Our data suggest that tamsulosin use benefits distal ureteral stones in facilitating
stone passage and relieving renal colic. Subgroup analyses find that tamsulosin provides
a superior expulsion rate for stones >5 mm, but no effect for stones ≤5 mm.
In this report, we looked at the efficacy and safety of tamsulosin for the treatment
of distal ureteral stones. We find that tamsulosin significantly facilitates the passage
of distal ureteral stones and relieves renal colic.