Benign Prostatic HyperplasiaPhase 4NCT07467343
Silodosin vs Tamsulosin for LUTS Due to BPH: A Randomized Crossover Trial
A Phase 4 study testing Silodosin and Tamsulosin in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
- What is being tested?
- Silodosin and Tamsulosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Mar 2026to 22 Oct 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Suspected neurogenic bladder
- Bladder neck contracture
- Urethral stricture
- Chronic urinary retention
- Prostate cancer
- Urinary bladder stones
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Ain Shams University Hospitals, Urology Outpatient Clinic
Cairo, 11566
Ahmed Kamal Mokhtar, MBBCh, 01200271186 ext. +20, Ahmed.mukhtar@med.asu.edu.eg
About this study
Official title: : 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
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?
Read more
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.
- Being tested
- Silodosin, Tamsulosin
- Keywords
- Silodosin, Tamsulosin, Alpha-1 Adrenergic Antagonists, Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms, International Prostate Symptom Score, Uroflowmetry, Postvoid Residual Urine
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SilodosinDrug
Silodosin 8 mg oral capsule administered once daily for 4 weeks during the assigned treatment period.
TamsulosinDrug
Tamsulosin 0.4 mg oral capsule administered once daily for 4 weeks during the assigned treatment period.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Silodosin; Drug: Tamsulosin |
| 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. Receives: Drug: Silodosin; Drug: Tamsulosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 4, and Week 8
Secondary outcomes (9)
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.
Measured: Baseline, Week 4, and Week 8
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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 4, and Week 8
Incidence of Ejaculatory Dysfunction
Number of participants reporting ejaculatory dysfunction during each treatment period.
Measured: Throughout Week 1 to Week 8
Incidence of Dizziness
Number of participants reporting dizziness during each treatment period.
Measured: Baseline to Week 4 and Week 4 to Week 8
Incidence of Hypotension
Number of participants reporting or developing hypotension during each treatment period.
Measured: Baseline to Week 4 and Week 4 to Week 8
Incidence of Ejaculatory Dysfunction
Number of participants reporting ejaculatory dysfunction during each treatment period.
Measured: 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.
Measured: Baseline to Week 4 and Week 4 to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start22 Mar 2026 (estimated)
- Primary completion22 Sep 2026 (estimated)
- Study completion22 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mokhtar kamal mustafa, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467343
- Sponsor's protocol ID
- FMASU MS 151/2026
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- : 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
- ClinicalTrials.gov ID
- NCT07467343
- Acronym / sponsor ID
- FMASU MS 151/2026
- Keywords
- Silodosin, Tamsulosin, Alpha-1 Adrenergic Antagonists, Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms, International Prostate Symptom Score, Uroflowmetry, Postvoid Residual Urine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 22 Mar 2026 (estimated)
- Primary completion
- 22 Sep 2026 (estimated)
- Study completion
- 22 Oct 2026 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Silodosin followed by Tamsulosin | Active comparator | Drug: Silodosin, Drug: TamsulosinParticipants 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 | Drug: Silodosin, Drug: TamsulosinParticipants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- Suspected neurogenic bladder
- Bladder neck contracture
- Urethral stricture
- Chronic urinary retention
- Prostate cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SilodosinSilodosin 8 mg oral capsule administered once daily for 4 weeks during the assigned treatment period. | Drug | Silodosin followed by Tamsulosin, Tamsulosin followed by Silodosin |
| TamsulosinTamsulosin 0.4 mg oral capsule administered once daily for 4 weeks during the assigned treatment period. | Drug | Silodosin followed by Tamsulosin, Tamsulosin followed by Silodosin |
Primary outcome
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.
9 secondary outcomes
Change in Postvoid Residual Urine Volume
Time frame: Baseline, Week 4, and Week 8
Change in Peak Urinary Flow Rate
Time frame: Baseline, Week 4, and Week 8
Change in Quality of Life Score
Time frame: Baseline, Week 4, and Week 8
Change in International Index of Erectile Function-5 Score
Time frame: Baseline, Week 4, and Week 8
Incidence of Ejaculatory Dysfunction
Time frame: Throughout Week 1 to Week 8
Incidence of Dizziness
Time frame: Baseline to Week 4 and Week 4 to Week 8
Incidence of Hypotension
Time frame: Baseline to Week 4 and Week 4 to Week 8
Incidence of Ejaculatory Dysfunction
Time frame: Baseline to Week 4 and Week 4 to Week 8
Incidence of Gastrointestinal Adverse Events
Time frame: Baseline to Week 4 and Week 4 to Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Silodosin and Tamsulosin in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed M Kamal, MBBCh (01200271186 ext. +02, Ahmed.mukhtar@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in International Prostate Symptom Score (time frame: Baseline, Week 4, and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.