Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
Conditions
Keywords
Silodosin, Tamsulosin, Alpha-1 Adrenergic Antagonists, Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms, International Prostate Symptom Score, Uroflowmetry, Postvoid Residual Urine
Brief 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.
Interventions
DRUGSilodosin
Silodosin 8 mg oral capsule administered once daily for 4 weeks during the assigned treatment period.
DRUGTamsulosin
Tamsulosin 0.4 mg oral capsule administered once daily for 4 weeks during the assigned treatment period.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomized in a 1:1 ratio to one of two treatment sequences in a 2-period crossover design. Sequence A will receive silodosin 8 mg once daily for 4 weeks followed by tamsulosin 0.4 mg once daily for 4 weeks. Sequence B will receive tamsulosin 0.4 mg once daily for 4 weeks followed by silodosin 8 mg once daily for 4 weeks. Efficacy and safety outcomes will be assessed at baseline, week 4, and week 8.
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Postvoid Residual Urine Volume | Baseline, Week 4, and Week 8 | Change in postvoid residual urine volume measured by pelvi-abdominal ultrasound from baseline to the end of each 4-week treatment period. |
| Change in Peak Urinary Flow Rate | Baseline, Week 4, and Week 8 | Change in peak urinary flow rate (Qmax) measured by uroflowmetry from baseline to the end of each 4-week treatment period. |
| Change in Quality of Life Score | Baseline, Week 4, and Week 8 | 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. |
| Change in International Index of Erectile Function-5 Score | Baseline, Week 4, and Week 8 | 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. |
| Incidence of Ejaculatory Dysfunction | Throughout Week 1 to Week 8 | Number of participants reporting ejaculatory dysfunction during each treatment period. |
| Incidence of Dizziness | Baseline to Week 4 and Week 4 to Week 8 | Number of participants reporting dizziness during each treatment period. |
| Incidence of Hypotension | Baseline to Week 4 and Week 4 to Week 8 | Number of participants reporting or developing hypotension during each treatment period. |
| Incidence of Gastrointestinal Adverse Events | Baseline to Week 4 and Week 4 to Week 8 | Number of participants reporting gastrointestinal adverse events during each treatment period. |
Countries
Egypt
Contacts
CONTACTAhmed M Kamal, MBBCh
Outcome results
None listed