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

NCT07467343 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-03-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07467343 on ClinicalTrials.gov