Abstract
BACKGROUND: Medical expulsive therapy (MET) is recommended for distal ureteral stones measuring 5 to 10 mm. Mirabegron, a β3-adrenergic agonist, has been proposed as a potential agent to improve stone expulsion rate (SER) and stone expulsion time (SET). This study aims to evaluate the efficacy of mirabegron compared to placebo for MET in distal ureteral stones. METHODS: A systematic literature search was conducted in PubMed, Embase, and Cochrane Central Register of Controlled Trials from inception until December 2023. Only randomized controlled trials (RCTs) were included in the analysis. RESULTS: Five RCTs including 419 patients were analyzed. No significant differences were observed between mirabegron and placebo for SER [risk ratio (RR): 1.49, 95% confidence interval (CI): 0.91-2.45, P=0.08, I(2)=53%], SET [mean difference (MD): -1.92, 95% CI: -5.38-1.54, P=0.28, I(2)=95%], or analgesic use (MD: -1.03, 95% CI: -2.16-0.09, P=0.07, I(2)=89%). Trial sequential analysis indicated that the current evidence remains insufficient to conclusively determine mirabegron's effect, though the accumulated data are approaching the futility boundary, suggesting that one additional RCT may be sufficient for a definitive conclusion. CONCLUSIONS: Mirabegron does not provide a significant benefit as a MET for distal ureteral stones measuring 5 to 10 mm. Further RCTs are necessary to establish its potential role in ureterolithiasis management.