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

Abstract

Objective: 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. Material and methods: A prospective, comparative study included 96 patients with radiopaque distal ureteral 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. Results: 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. Conclusion: Mirabegron is an effective and safe medical expulsive therapy agent in patients with 5-10 mm distal ureteral stones.

Efficacy of mirabegron for ureteral stones: a systematic review with meta-analysis of randomized controlled trials

“…Study characteristics are summarized in Table 1 , comprising 701 participants. All studies were RCTs ( Bayar et al, 2020 ; Abdel-Basir Sayed et al, 2022 ; Mayer, 2022 ; Morsy et al, 2022 ; Rajpar et al, 2022 ; EAU, 2023 ; Samir et al, 2023 ), which had accrued between September 2009 and November 2022 ( Figure 1 ). These studies were conducted in the United States, Pakistan, Turkey, Egypt, China, and Saudi Arabia.…”

“…For ureteral stones <10 mm, 68% of patients in group A expelled the stone during therapy, compared to 60% and 20% in groups B and C, respectively ( Morsy et al, 2022 ). Furthermore, based on the data on Tang et al, in patients with 5-mm stones, the experimental group (mirabegron 50 mg once daily plus tamsulosin 0.2 mg once daily) had a higher SER than the control group (tamsulosin 0.2 mg once daily) ( Abdel-Basir Sayed et al, 2022 ). Although mirabegron appears to demonstrate a similar or even superior stone expulsion effect compared to tamsulosin, further large-scale RCTs are essential to substantiate these findings.…”

Efficacy of Mirabegron in Medical Expulsive Therapy for Ureteral Stones: A Systematic Review and Updated Meta-analysis

“…4B). Three trials reported analgesic consumption in the articles which showed less analgesic consumption in the mirabegron group [10,11,15]. But we could not conduct an overall quantitative analysis of the amount of analgesic consumption due to different types of analgesics used in each study.…”

“…The search strategy identi ed 456 articles and 6 trials [10][11][12][13][14][15] (including 5 RCTs) with 462 patients were included in the nal analysis. The literature screening process is shown in Fig.…”

“…Four studies [10][11][12]15] reported the adverse events during treatment. Bayar reported that one patient experienced an episode of hypertension in the mirabegron group.…”