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Not yet recruiting NCT07467343

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

Phase IV Interventional Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Silodosin, Tamsulosin.
Who it may be relevant to
Registry conditions: Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms. Basic parameters: from 50 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

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.

Primary outcome measures

  • Change in International Prostate Symptom Score [Time frame: Baseline, Week 4, and Week 8]
Secondary outcome measures (9)
  • Change in Postvoid Residual Urine Volume [Time frame: Baseline, Week 4, and Week 8]
  • Change in Peak Urinary Flow Rate [Time frame: Baseline, Week 4, and Week 8]
  • Change in Quality of Life Score [Time frame: Baseline, Week 4, and Week 8]
  • Change in International Index of Erectile Function-5 Score [Time frame: Baseline, Week 4, and Week 8]
  • Incidence of Ejaculatory Dysfunction [Time frame: Throughout Week 1 to Week 8]
  • Incidence of Dizziness [Time frame: Baseline to Week 4 and Week 4 to Week 8]
  • Incidence of Hypotension [Time frame: Baseline to Week 4 and Week 4 to Week 8]
  • Incidence of Ejaculatory Dysfunction [Time frame: Baseline to Week 4 and Week 4 to Week 8]
  • Incidence of Gastrointestinal Adverse Events [Time frame: Baseline to Week 4 and Week 4 to Week 8]

Eligibility criteria

Inclusion criteria

  • Male participants aged 50 years or older
  • Diagnosis of benign prostatic hyperplasia with moderate to severe lower urinary tract symptoms
  • International Prostate Symptom Score of 8 or greater
  • Prostate volume of 30 mL or greater
  • Able and willing to provide informed consent
  • No active treatment for benign prostatic hyperplasia during the month before enrollment

Exclusion criteria

  • Suspected neurogenic bladder
  • Bladder neck contracture
  • Urethral stricture
  • Chronic urinary retention
  • Prostate cancer
  • Urinary bladder stones
  • Urinary bladder tumors
  • History of prostate surgery
  • Known allergy, hypersensitivity, or contraindication to silodosin or tamsulosin
  • Current use of alpha-adrenergic blocker therapy
  • Severe renal impairment with creatinine clearance less than 30 mL/min
  • Severe hepatic impairment
  • Concomitant use of strong cytochrome P450 3A4 inhibitors, including ketoconazole, clarithromycin, itraconazole, or ritonavir

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Ain Shams University Hospitals, Urology Outpatient Clinic — Cairo

Identifiers

NCT: NCT07467343 · FMASU MS 151/2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗