NCT07467343

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

: Efficacy of Silodosin Versus Tamsulosin in Patients With Moderate to Severe Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia: A Randomized Crossover Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Benign Prostatic Hyperplasia
• Lower Urinary Tract Symptoms

Interventions

Type	Name	Description
DRUG	Silodosin	Silodosin 8 mg oral capsule administered once daily for 4 weeks during the assigned treatment period.
DRUG	Tamsulosin	Tamsulosin 0.4 mg oral capsule administered once daily for 4 weeks during the assigned treatment period.

Timeline

• Start date: 2026-03-22
• Primary completion: 2026-09-22
• Completion: 2026-10-22
• First posted: 2026-03-12
• Last updated: 2026-03-16

Locations

1 site across 1 country: Egypt