Silodosin: Silodosin 8 mg oral capsule administered once daily for 4 weeks during the assigned treatment period.
Tamsulosin: Tamsulosin 0.4 mg oral capsule administered once daily for 4 weeks during the assigned treatment period.
Study summary
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
Sex
MALE
Min age
50 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Change in International Prostate Symptom Score — Baseline, Week 4, and Week 8 Change in total International Prostate Symptom Score from baseline to the end of each 4-week treatment period to compare symptom improvement with silodosin and tamsulosin in patients with benign prostatic hyperplasia-associated lower urinary tract symptoms. The International Prostate Symptom Score ranges from 0 to 35, with higher scores indicating more severe symptoms.
Trial sites (1)
Facility
City
Region
Status
Ain Shams University Hospitals, Urology Outpatient Clinic
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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