: Efficacy of Silodosin Versus Tamsulosin in Patients With Moderate to Severe Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia: A Randomized Crossover Clinical Trial
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Ain Shams University
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Change in International Prostate Symptom Score
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts 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
Arms & Interventions
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.
Intervention: Silodosin (Drug)
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.
Intervention: Tamsulosin (Drug)
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.
Intervention: Silodosin (Drug)
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.
Intervention: Tamsulosin (Drug)
Outcomes
Primary Outcomes
Change in International Prostate Symptom Score
Time Frame: 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 Outcomes
- Change in Quality of Life Score(Baseline, Week 4, and Week 8)
- Change in International Index of Erectile Function-5 Score(Baseline, Week 4, and Week 8)
- Change in Postvoid Residual Urine Volume(Baseline, Week 4, and Week 8)
- Change in Peak Urinary Flow Rate(Baseline, Week 4, and Week 8)
- Incidence of Ejaculatory Dysfunction(Throughout Week 1 to Week 8)
- Incidence of Dizziness(Baseline to Week 4 and Week 4 to Week 8)
- Incidence of Hypotension(Baseline to Week 4 and Week 4 to Week 8)
- Incidence of Ejaculatory Dysfunction(Baseline to Week 4 and Week 4 to Week 8)
- Incidence of Gastrointestinal Adverse Events(Baseline to Week 4 and Week 4 to Week 8)
Investigators
Ahmed Mokhtar kamal mustafa
Resident of Urology
Ain Shams University