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NOT YET RECRUITING
NCT07467343
PHASE4

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

Sponsor: Ain Shams University

View on ClinicalTrials.gov

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.

Official title: : 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

Key Details

Gender

MALE

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2026-03-22

Completion Date

2026-10-22

Last Updated

2026-03-16

Healthy Volunteers

No

Interventions

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.

Locations (1)

Ain Shams University Hospitals, Urology Outpatient Clinic

Cairo, Egypt