Silodosin vs Tamsulosin for LUTS Due to BPH: A Randomized Crossover Trial
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age50+
SponsorAin Shams University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Suspected neurogenic bladder
Bladder neck contracture
Urethral stricture
Chronic urinary retention
Trial design
Design model
Crossover
Treatments tested in this trial
Silodosin
DrugSilodosin 8 mg oral capsule administered once daily for 4 weeks during the assigned treatment period.
Tamsulosin
DrugTamsulosin 0.4 mg oral capsule administered once daily for 4 weeks during the assigned treatment period.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Silodosin followed by TamsulosinActive comparator 2 interventions
Group B: Tamsulosin followed by SilodosinActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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 8Secondary outcomes
1
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 82
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 83
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 84
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 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: