COMPARATIVE ANALYSIS OF SILODOSIN MONOTHERAPY VERSUS SILODOSIN + MIRABEGRON ADD-ON THERAPY FOR DISTAL URETERIC STONE BETWEEN 4 TO 10MM

Abstract

Objective: To compare the efficacy and safety of silodosin monotherapy versus silodosin combined with mirabegron in the management of distal ureteric stones measuring 4–10 mm. Study Design: Prospective, randomized controlled trial. Place and Duration of Study: Sahiwal Teaching Hospital, Sahiwal, from November 2025 to February 2026. Methodology: A total of 40 patients with distal ureteric stones between 4–10 mm were enrolled and randomly divided into two equal groups (n=20 each). Group-A received silodosin 8 mg daily, while Group-B received silodosin 8 mg plus mirabegron 50 mg daily for a maximum duration of four weeks or until spontaneous stone expulsion. The primary outcome was stone expulsion rate. Secondary outcomes included time to stone expulsion, number of renal colic episodes, additional analgesic requirement, and adverse effects. Data were analyzed using SPSS version 25.0, and p-value <0.05 was considered statistically significant. Results: The stone-free rate was higher in Group-B compared to Group-A (45% vs 25%), but the difference was not statistically significant (p=0.320). Mean stone expulsion time was comparable between Group-A and Group-B (16.40 ± 7.92 days vs 17.22 ± 8.01 days, p=0.857). There were no significant differences in renal colic episodes (2.40 ± 1.98 vs 2.80 ± 1.96, p=0.525) or additional analgesic requirement (2.45 ± 1.61 vs 2.55 ± 1.64, p=0.846). Both treatment regimens were well tolerated, with no significant difference in adverse effects between groups (p=0.266). Conclusion: Silodosin monotherapy and silodosin plus mirabegron combination therapy demonstrated comparable efficacy and safety in the treatment of distal ureteric stones measuring 4–10 mm.