Comparative efficacy and safety of silodosin (Silorap®) versus tamsulosin (Tamsolin®) for medical expulsive therapy of distal ureteral stones

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Abstract Purpose The study objective was to compare the efficacy and safety of Silodosin (Silorap ® ) versus Tamsulosin (Tamsolin ® ) in facilitating the passage of acutely obstructing distal ureteral stones. Methods This multicenter, randomized, comparative study enrolled 336 adult patients with a single distal ureteric calculus (5–10 mm) across sixteen tertiary care centers in Pakistan. Participants were randomized to receive Silodosin (Silorap ® ) or Tamsulosin (Tamsolin ® ) and followed for 30 days. Primary outcome was stone expulsion rate at four weeks; secondary outcomes included time to expulsion, analgesic use, emergency visits, and safety outcomes. Results Baseline characteristics were comparable between groups. The stone expulsion rate was significantly higher with Silodosin (112/166; 67.47%) than with Tamsulosin (92/170; 54.12%; p = 0.012). Mean expulsion time was 13.68 ± 8.97 days for Silodosin and 14.33 ± 9.65 days for Tamsulosin (median 12 days; p = 0.701). Kaplan–Meier analysis showed similar time to passage (log-rank p = 0.728). Pain scores declined significantly in both groups. Both treatments were well tolerated; headache and postural hypotension were the most common adverse events, while retrograde ejaculation occurred more frequently with Silodosin. Serious events such as palpitation and syncope were rare and manageable, with no significant differences in vital signs. Conclusion Silodosin (Silorap ® ) and Tamsulosin (Tamsolin ® ) are effective and well tolerated for medical expulsive therapy in distal ureteral stones. Silodosin achieved a higher stone expulsion rate, though time to expulsion was similar between groups. Trial registration ClinicalTrials.gov ID NCT05977647; Date of registration: 2023-08-04.

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