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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silodosin followed by Tamsulosin | Active Comparator | 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. |
|
| Tamsulosin followed by Silodosin | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silodosin | Drug | Silodosin 8 mg oral capsule administered once daily for 4 weeks during the assigned treatment period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 4, and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 4, and Week 8 |
| Change in Peak Urinary Flow Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed M Kamal, MBBCh | Contact | 01200271186 | +02 | Ahmed.mukhtar@med.asu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Hospitals, Urology Outpatient Clinic | Cairo | 11566 | Egypt |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C095285 | silodosin |
| D000077409 | Tamsulosin |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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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.
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| Tamsulosin | Drug | Tamsulosin 0.4 mg oral capsule administered once daily for 4 weeks during the assigned treatment period. |
|
Change in peak urinary flow rate (Qmax) measured by uroflowmetry from baseline to the end of each 4-week treatment period.
| 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. | 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. | Baseline, Week 4, and Week 8 |
| Incidence of Ejaculatory Dysfunction | Number of participants reporting ejaculatory dysfunction during each treatment period. | Throughout Week 1 to Week 8 |
| Incidence of Dizziness | Number of participants reporting dizziness during each treatment period. | Baseline to Week 4 and Week 4 to Week 8 |
| Incidence of Hypotension | Number of participants reporting or developing hypotension during each treatment period. | Baseline to Week 4 and Week 4 to Week 8 |
| Incidence of Ejaculatory Dysfunction | Number of participants reporting ejaculatory dysfunction during each treatment period. | 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. | Baseline to Week 4 and Week 4 to Week 8 |
| D052801 |
| Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |