Silodosin versus Tamsulosin as Medical Expulsive Therapy for Children with Lower-Third Ureteric Stones: Prospective Randomized Placebo-Controlled Study.

AIM

To compare the efficacy and safety of silodosin versus tamsulosin as medical expulsive therapy for stones of lower-third ureter in children.

PATIENTS AND METHODS

This prospective single-blind placebo-controlled randomized study included 167 pediatric patients who presented with distal ureteric stone (DUS) less than 1 cm. Patients were randomized into 3 groups; group I received silodosin 4 mg once daily, and group II received tamsulosin 0.4 mg while those in group III had placebo. The side effects of the used drugs, both rate and time of stone expulsion, and number of pain episodes were compared among the study groups for a maximum of 4 weeks.

RESULTS

Follow-up data of our patients after treatment revealed that the stone expulsion rate was significantly higher and the time to stone expulsion was significantly shorter in group I (89.3%, 12.4 ± 2.3 days) and group II (74.5%, 16.2 ± 4.2 days) compared to group III (51.8%, 21.2 ± 5.6). However, a statistically significant difference between silodosin and tamsulosin groups in favor of the former one was reported regarding the 2 studied items. Meanwhile, pain episodes requiring analgesia were statistically fewer in group I and II in contrast to placebo group. Adverse events were comparable among all groups.

CONCLUSION

Silodosin provides significantly better stone expulsion rate and shorter expulsion time than tamsulosin for treatment of DUS. Both medications showed good safety profiles in children. However, further studies are required on a larger scale to confirm our results. Assessment of drug safety on younger age-group is still needed.