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

Sponsor
Ain Shams University
Study ID
NCT07467343
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Silodosin — DRUG
    Silodosin 8 mg oral capsule administered once daily for 4 weeks during the assigned treatment period.
  • Tamsulosin — DRUG
    Tamsulosin 0.4 mg oral capsule administered once daily for 4 weeks during the assigned treatment period.

Study Details

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.

Key Dates

Start date
Mar 22, 2026
Status verified
Mar 2026
Primary completion
Sep 22, 2026
Completion
Oct 22, 2026

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Silodosin followed by Tamsulosin
    Participants assigned to this sequence will receive silodosin 8 mg oral capsules once daily for 4 weeks, followed by tamsulosin 0.4 mg oral capsules once daily for 4 weeks. Outcomes will be assessed at baseline, week 4, and week 8, including International Prostate Symptom Score, post-void residual urine volume, uroflowmetry parameters, quality of life, sexual function, and adverse events.
  • Active Comparator: Tamsulosin followed by Silodosin
    Participants assigned to this sequence will receive tamsulosin 0.4 mg oral capsules once daily for 4 weeks, followed by silodosin 8 mg oral capsules once daily for 4 weeks. Outcomes will be assessed at baseline, week 4, and week 8, including International Prostate Symptom Score, post-void residual urine volume, uroflowmetry parameters, quality of life, sexual function, and adverse events.

Primary Outcome Measure

Change in International Prostate Symptom Score [ Time Frame: Baseline, Week 4, and Week 8 ]

Central Contacts

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