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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age50+
SponsorAin Shams University

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

Treatment groups

140 Participants
are divided into 2 treatment groups

Sponsors and collaborators