Comparison of safety and efficacy of silodosin versus mirabegron in medical expulsive therapy for lower ureteric stone: a prospective, open label and randomized controlled trial

Background: Urolithiasis the most common condition affecting genitourinary tract and affect 5 to 10% of population worldwide. Almost all ureteric stones are symptomatic, and patients need to receive immediate evaluation and pain relief treatment. Passage of stone is facilitated by medical expulsive therapy (MET). Overall, 71-98% for stones in the distal ureter that are 5 mm or smaller passes with MET while 29-98% for stones in the proximal ureter that are 5 mm or smaller passes with MET. Silodosin (alpha-1 adrenergic receptor antagonist) and mirabegron (β-3 agonist) were compared for stone expulsion and analgesic effects for symptomatic relief. Methods: The study was conducted in the department of pharmacology and the department of urology at Dr. R. P. G. M. C., Kangra at Tanda Himachal Pradesh, India which is 700 bedded multispecialty tertiary health care from August 2023to May 2024 and follow-up was done for 4 weeks after initiation of treatment, to compare the safety and efficacy of silodosin versus mirabegron in medical expulsion therapy for lower ureteric stone of size≤10 mm in adults. Results: In our study patients in silodosin treatment arm had a smaller number of colick episodes (mean 1.65±1.02) during MET as compared to group (mean 2.23±1.07) receiving mirabegron (p=0.011). Patients in silodosin group had significantly lower analgesic requirement (mean 2.10±1.58) as compared to patients in mirabegron (mean 3.30±1.96) which is also statistically significant (p=0.002). Patients in silodosin group had highly significant lower time for stone expulsion (mean 10.0±5.3) as compared to that in patients in mirabegron group (mean 15.7±7.1) (p=0.0004). Overall, incidence of side effects was similar in both groups. Conclusions: Silodosin demonstrated superior efficacy over Mirabegron in terms of reducing colic episodes, analgesic requirement and stone expulsion time in the management of ureteric calculi. No significant adverse events were reported in either group during the study period