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

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.

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