Comparative Evaluation of the Efficacy of Injectable Dexamethasone and Oral Tamsulosin Versus Oral Tamsulosin Alone on Pain Reduction in Ureteral Stones Smaller Than 1 cm: A Double-Blind Randomized Controlled Trial

Abstract

Background: Distal ureteral stones <10 mm are a frequent cause of emergency urological visits. Medical expulsive therapy (MET) with alpha-blockers such as tamsulosin is commonly used, yet adjunctive anti-inflammatory agents may enhance efficacy. This study evaluated whether adding intramuscular dexamethasone to oral tamsulosin improves stone expulsion outcomes compared to tamsulosin monotherapy. Methods: In this double-blind, parallel-group randomized controlled trial, 110 adults with symptomatic distal ureteral stones ≤10 mm confirmed by non-contrast CT were randomized 1:1 to receive either oral tamsulosin 0.4 mg daily plus intramuscular dexamethasone 8 mg weekly (intervention group, n=55) or oral tamsulosin plus intramuscular normal saline placebo (control group, n=55). Treatment continued for up to 14 days or until stone passage. The primary outcome was stone expulsion rate by day 14 analgesic use (diclofenac suppositories). Findings: A total of 104 patients (52 per group) completed the trial. Mean time to expulsion was significantly shorter with dexamethasone (2.91 ± 1.56 vs 4.09 ± 1.58 days; P=0.001). The intervention group required fewer diclofenac suppositories (2.38 ± 1.36 vs 3.42 ± 0.82; P < 0.001) and lost fewer work days (2.62 ± 2.05 vs 4.10 ± 2.15; P=0.001). Conclusion: Weekly intramuscular dexamethasone combined with daily oral tamsulosin significantly improved stone expulsion rate, reduced analgesic use, and minimized work absence compared to tamsulosin alone, supporting its role as an enhanced MET strategy for distal ureteral stones <10 mm. © 2026, Isfahan University of Medical Sciences(IUMS). All rights reserved.