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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Silodosin 8 mg oral capsule administered once daily for 4 weeks during the assigned treatment period.
Tamsulosin 0.4 mg oral capsule administered once daily for 4 weeks during the assigned treatment period.
Ain Shams University Hospitals, Urology Outpatient Clinic
Cairo, Egypt
Change in International Prostate Symptom Score
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.
Time frame: Baseline, Week 4, and Week 8
Change in Postvoid Residual Urine Volume
Change in postvoid residual urine volume measured by pelvi-abdominal ultrasound from baseline to the end of each 4-week treatment period.
Time frame: Baseline, Week 4, and Week 8
Change in Peak Urinary Flow Rate
Change in peak urinary flow rate (Qmax) measured by uroflowmetry from baseline to the end of each 4-week treatment period.
Time frame: Baseline, Week 4, and Week 8
Change in Quality of Life Score
Change in quality of life score assessed using the quality of life item of the International Prostate Symptom Score (IPSS) questionnaire. The IPSS quality of life question is scored from 0 to 6, where 0 indicates "delighted" and 6 indicates "terrible." Higher scores indicate worse quality of life related to urinary symptoms.
Time frame: Baseline, Week 4, and Week 8
Change in International Index of Erectile Function-5 Score
Change in erectile function assessed using the International Index of Erectile Function-5 (IIEF-5) questionnaire. The IIEF-5 score ranges from 5 to 25, with higher scores indicating better erectile function.
Time frame: Baseline, Week 4, and Week 8
Incidence of Ejaculatory Dysfunction
Number of participants reporting ejaculatory dysfunction during each treatment period.
Time frame: Throughout Week 1 to Week 8
Incidence of Dizziness
Number of participants reporting dizziness during each treatment period.
Time frame: Baseline to Week 4 and Week 4 to Week 8
Incidence of Hypotension
Number of participants reporting or developing hypotension during each treatment period.
Time frame: Baseline to Week 4 and Week 4 to Week 8
Incidence of Ejaculatory Dysfunction
Number of participants reporting ejaculatory dysfunction during each treatment period.
Time frame: Baseline to Week 4 and Week 4 to Week 8
Incidence of Gastrointestinal Adverse Events
Number of participants reporting gastrointestinal adverse events during each treatment period.
Time frame: Baseline to Week 4 and Week 4 to Week 8
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