Mirabegron as a Medical Expulsive Therapy for 5-10 mm Distal Ureteral Stones: A Prospective, Randomized, Comparative Study.

Abstract

The aim of this study was to assess the efficacy and safety of mirabegron as a medical expulsive therapy in patients with distal ureteral stones of 5-10 mm size. A prospective, comparative study included 96 patients with radiopaque distal ure- teral stones of 5-10 mm who were randomly allocated and treated by medical expulsive therapy in 2 groups from January 2019 to December 2020. Patients in group A received only ketorolac 30 mg/day for 5 days, then on demand. Patients in group B received mirabegron 50 mg/day for 4 weeks plus ketorolac 30 mg/day like in group A. The stone expulsion rate was the primary outcome. There were no significant differences regarding age, gender, body mass index, laterality, degree of hydronephrosis, and stone size. After 4 weeks, stone expulsion rate was 52.1% for group A versus 89.6% for group B (P < .001). The median (range) of time to stone expulsion was 14 (13-23) and 7 (3-16) days for groups A and B, respectively (P = .004). The medians (range; interquartile range) of episodes of renal pain (1 (0-2; 1) vs. (0-2; 2); P < .001) and extra analgesic ampoules (1 (0-7; 4) vs. 0 (0-2; 0) vials; P < .001) were significantly higher in group A than those in group B, respectively. In multivariate analysis, only medical expulsive therapy (P <.001) and stone size (P < .001) were independent predictors of stone expulsion rate. Mirabegron is an effective and safe medical expulsive therapy agent in patients with 5-10 mm distal ureteral stones.