drugset / Trial / NCT05977647

Medical Stone Expulsive Therapy for Acutely Obstructed Ureteric Calculi

NCT05977647

Phase 4 Completed 240 enrolled Getz Pharma
RandomizedParallel-groupOpen-labelTreatment

Summary

As a first treatment option for small-size ureteric stones, α-blockers are now being used for medical expulsive therapy (MET) instead of invasive procedures. There is high evidence of the therapeutic benefit of α-blockers in the treatment of Distal ureteric stone (DUS); also endorsed by international guidelines. However, limited data is available worldwide, on the effect of silodosin to treat DUS. A multi-center study is needed to confirm the efficacy and safety of therapy.

Timeline

Start
2024-09-01
Primary completion
2025-05-30
Completion
2025-06-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Silodosin Unknown 8 mg Oral
Comparator Tamsulosin Other / unclassified 0.4 mg Oral

Indications