Efficacy and Safety of Tamsulosin in Medical Expulsive Therapy for Distal Ureteral Stones with Renal Colic: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial
Abstract:
Background: Recent large high-quality trials have questioned the clinical effectiveness
of medical expulsive therapy using tamsulosin for ureteral stones.
Objective: To evaluate the efficacy and safety of tamsulosin for distal ureteral stones
compared with placebo.
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.
Intervention: 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.
Conclusions: 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.
Patient summary: 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.
© 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.