Safety and efficacy of Silodosin as medical expulsive therapy after shock wave lithotripsy in paediatric patients ‍‍with renal stones.

Abstract

This study was designed to assess the safety and efficacy of Silodosin as a medical expulsive therapy following shockwave lithotripsy (SWL) in paediatric patients with renal stones. In this prospective randomized controlled study conducted at Tanta University Hospital from January 2022 to March 2024, thirty children with a single de novo radiopaque renal pelvic stone less than 2 cm scheduled for SWL were randomized into two equal groups. Group A (n = 15) received Silodosin 4 mg once daily after the first SWL session, and Group B (n = 15) received a matching placebo. The first dose was administered on the night of the initial SWL session and continued until stone-free status was confirmed, for a maximum of 4 weeks. The stone expulsion time was set as a primary outcome, while the secondary outcomes were one-session stone-free rate (SFR), postoperative pain scores, and Silodosin related adverse events. The results showed that the mean stone expulsion time in group A (11.4 ± 1.8 days) was significantly shorter compared to group B (16.4 ± 1.6 days; P < 0.0001). One-session SFR was 86.6% in Silodosin group compared to 73.3% in Placebo group (P = 0.6). Pain visual analogue scores were significantly lower in group A (2.31 ± 1.75) than in group B (5.08 ± 2.43; P = 0.003). No severe drug-related adverse effects were reported in either group. In conclusion, Silodosin appears to be a safe and effective adjunct to SWL in paediatric patients, significantly reducing stone expulsion time and postoperative pain. Larger studies are needed to confirm these findings.