drugset / Trial / NCT04819828

Tamsulosin as Adjunctive Therapy After Extracorporeal Shock Wave Lithotripsy for Renal Stones

NCT04819828 ↗

Phase 4 Completed 60 enrolled Hospital Regional de Alta Especialidad del Bajio
RandomizedParallel-groupDouble-blindTreatment

Summary

Urolithiasis is a common health problem worldwide affecting approximately 10% of the population at some stage in their lives. The aim of this study is to evaluate the efficacy of adjuvant treatment with tamsulosin for improving the stone-free rate after a single session of extracorporeal shock wave lithotripsy (ESWL) in the treatment of radiopaque kidney stones.

Timeline

Start
2010-01-01
Primary completion
2016-08-31
Completion
2016-12-31

Outcome

Missed primary endpoint

paper 53.57% (15 of 28) for the tamsulosin group, and 48.27% (14 of 29) for the control group (p = 0.680). PMID 35685573 ↗

paper it does not increase the stone-free rate in patients with a single radiopaque renal stone of 5-20 mm in diameter. PMID 35685573 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Tamsulosin Other / unclassified 0.4 mg Oral
Background Diclofenac Other / unclassified 75 mg Oral

Indications