Efficacy of Mirabegron as Medical Expulsive Therapy for Distal Ureteral Stones: A Prospective, Randomized, Double-Blinded, Controlled Study

Abstract

<b><i>Background:</i></b> Today, medical expulsive therapy (MET) is more effective and commonly used in distal ureteral stones when compared with conservative treatments. Many treatments, namely, alpha-adrenergic blockers and calcium channel blockers, prostaglandin synthesis inhibitors, glyceryl trinitrate, and steroids, have been, therefore, utilized to mitigate such complications and accelerate stone expulsion. Several animal and human studies revealed the presence of β3-receptors in the ureter and bladder, where stimulating these receptors could relax the distal ureteral segment. <b><i>Objectives:</i></b> The aim of the study was to evaluate the efficacy of use of mirabegron as MET for distal ureteral stones (intramural and extramural). <b><i>Methods:</i></b> This is a prospective randomized controlled study including 90 patients who had distal ureteral stones less than 10 mm and were evaluated between January and June 2020. The patients were classified into 3 groups: group (A) 30 patients: mirabegron 50 mg d<sup>−1</sup> + diclofenac Na 100 mg tab (to be taken only during colic episodes), group (B) 30 patients: tamsulosin HCL 0.4 mg cap + diclofenac Na 100 mg tab (to be taken only during colic episodes), and group (C) 30 patients: diclofenac Na 100 mg tab only (to be taken only during colic episodes). Age, sex, stone size, laterality, and grade of ureterohydronephrosis were recorded. Patients were observed for 30 days, and ureteroscopy was completed for those with nonexpulsed stones. Follow-up parameters included number of renal colic episodes, duration of medical therapy, stone expulsion time, and stone expulsion rate (SER). <b><i>Results:</i></b> In the group (A), 2 (6.6%) patients were excluded due to nasal congestion, and 1 (3.3%) patient was excluded due to a 20-mm Hg systolic blood pressure increase. Four (13.3%) patients in group (B) were noncompliant on medical treatment. In addition, 2 (6.6%) patients in group (A), 1 (3.3%) patient in group (B), and 5 (16.6%) patients in group (C) who did not attend follow-up examinations were excluded from the study. The SER increased significantly in group (A) and (B) when compared with group (C). The mean time of stone expulsion was about 15, 25, and 12 days for groups A, B, and C, respectively, and there was a significant statistical difference (<i>p</i> value = 0.006) among the 3 groups. The mean number of renal colic episodes of group (A) of patients was 1.8 times, while that of group (B) was 2.6 times and that of group (C) was 2.16 times with no significant statistical difference after comparing the 3 groups (<i>p</i> value = 0.660). <b><i>Conclusions:</i></b> Treatment with mirabegron appears to be a safe and effective medical expulsion therapy for distal ureteric stones and is better than tamsulosin.

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.…”

“…Diclofenac Na was administered to all groups just for pain relief. 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 ).…”

Evaluating the Safety and Effectiveness of α-Blockers Versus Mirabegron for Medical Expulsive Therapy in Ureteral Calculi: A Systematic Review and Meta-Analysis

“…Five RCTs [20][21][22][23][24] involving 478 patients ful lled the inclusion and exclusion criteria for the analysis. The literature selection process is illustrated in Fig.…”

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

“…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.…”