About this 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Suspected neurogenic bladder
Bladder neck contracture
Urethral stricture
Chronic urinary retention
Trial design
Treatments tested in this trial
- Silodosin
- Tamsulosin