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

StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 16, 2026 (before its estimated September 22, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Secondary endpoints: details revised at 2 of 9 entriesv2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07467343
Lead Sponsor Ain Shams University
Conditions Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov