Silodosin vs Tamsulosin for LUTS Due to BPH: A Randomized Crossover Trial (NCT07467343) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Silodosin vs Tamsulosin for LUTS Due to BPH: A Randomized Crossover Trial
Egypt140 participantsStarted 2026-03-22
Plain-language 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.
Who can participate
Age range
50 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.