drugset / Trial / NCT07467343

Silodosin vs Tamsulosin for LUTS Due to BPH: A Randomized Crossover Trial

NCT07467343

Phase 4 Not yet recruiting 140 enrolled Ain Shams University
RandomizedCrossoverOpen-labelTreatment

Summary

The goal of this randomized crossover clinical trial is to compare the efficacy and safety of Silodosin versus Tamsulosin in patients with moderate to severe lower urinary tract symptoms due to Benign Prostatic Hyperplasia. The main questions it aims to answer are: Does Silodosin provide superior improvement in symptom scores (IPSS) compared to Tamsulosin? Is there a difference in safety profile and adverse events between the two treatments? Researchers will compare both treatments in a crossover design, where each participant receives both medications in different periods without a washout phase, to evaluate individual response differences. Participants will: Receive both study medications in different periods according to random allocation. Undergo periodic assessment of urinary symptoms and quality of life. Perform routine follow-up evaluations including symptom scoring and urine flow measurements.

Timeline

Start
2026-03-22
Primary completion
2026-09-22
Completion
2026-10-22

Drugs

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