Benign Prostatic HyperplasiaPhase 4NCT07743034
Iris Structural Changes With Tamsulosin vs. Silodosin in Benign Prostatic Hyperplasia Patients
A Phase 4 study testing tamsulosin 0.4mg and Silodosin 8 mg in people with Benign Prostatic Hyperplasia and Tamsulosin, run by Mohsen Pourazizi.
Trial summary
Inhibition of alpha-1 adrenergic receptors by drugs such as tamsulosin and silodosin, which are prescribed for the treatment of benign prostatic hyperplasia, can lead to intraoperative floppy iris syndrome (IFIS) during cataract surgery. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Tamsulosin, Silodosin
- What is being tested?
- tamsulosin 0.4mg and Silodosin 8 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Apr 2027
- 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
- Men ≥ 50 years old with a definitive diagnosis of BPH by a urologist colleague.
- Patients with moderate symptoms based on the International Prostate Symptom Score (IPSS): score 8 to 19
- No prior use of alpha-blockers (tamsulosin, silodosin, doxazosin, etc.)
- Satisfactory vision for imaging and acceptable scan quality according to device criteria.
- Consent to participate in the study
Who cannot join
- Insufficient image quality in assessments
- History of intraocular surgery
- Uncontrolled hypertension
- Iris trauma
- Patient unwillingness to continue participation in the study
- Occurrence of unwanted systemic complications during the study
Show all 9Show fewer
- Incorrect medication adherence during the study
- Diabetes
- Hypertension
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of the Efficacy of Tamsulosin and Silodosin on Anatomical Iris Changes in Patients With Benign Prostatic Hyperplasia: A Single-blind Randomized Clinical Trial
Inhibition of alpha-1 adrenergic receptors by drugs such as tamsulosin and silodosin, which are prescribed for the treatment of benign prostatic hyperplasia, can lead to intraoperative floppy iris syndrome (IFIS) during cataract surgery. IFIS is a phenomenon characterized by a small, poorly dilating pupil and causes surgical difficulty.
Main objective: To determine and compare changes in the anatomical structure of the iris in patients with BPH before and after treatment with tamsulosin and silodosin.
Read more
Men aged 50 years and older with a definitive diagnosis of BPH who have no prior history of alpha-blocker use will be enrolled in one of the two treatment arms - tamsulosin or silodosin. Imaging will be performed using an MS-39 device (manufactured by CSO, Italy); assessments will be conducted at two time points - before the start of treatment and after three months of continuous drug use. At baseline and three months after treatment, using AS-OCT, the DMR and SMR regions and other ocular angle indices will be measured. Medication adherence will be assessed by counting the capsules used by each patient.
Specific Objectives:
- To determine changes in the dilator muscle region (DMR) under scotopic, mesopic, photopic, and post-dilation conditions from baseline to the third month in the tamsulosin \& silodosin groups and compare them.
- To determine changes in SMR under scotopic, mesopic, photopic, and post-dilation conditions from baseline to the third month in the tamsulosin \& silodosin groups and compare them.
- Conditions
- Benign Prostatic Hyperplasia, Tamsulosin, Silodosin, Intraoperative Floppy Iris Syndrome, Tomography, Optical Coherence, Iris Diseases
- Being tested
- tamsulosin 0.4mg, Silodosin 8 mg
- Keywords
- Benign Prostatic Hyperplasia, Tamsulosin, Intraoperative Floppy Iris Syndrome, Tomography, Optical Coherence, Iris, Silodosin, IFIS
- Medical subject headings
- Prostatic Hyperplasia, Iris Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tamsulosin 0.4mgDrug
Tamsulosin 0.4 mg, daily.
Silodosin 8 mgDrug
Silodosin 8 mg, daily.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Tamsulosin | Active comparator | Tamsulosin 0.4 mg, daily. Receives: Drug: tamsulosin 0.4mg |
| Group 2: Silodosin | Active comparator | Silodosin 8 mg, daily. Receives: Drug: Silodosin 8 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the dilator muscle region (DMR)
To determine changes in the DMR under scotopic, mesopic, photopic, and post-dilation conditions.
Measured: From baseline to the third month.
Changes in the sphincter muscle region (SMR)
To determine changes in the SMR under scotopic, mesopic, photopic, and post-dilation conditions.
Measured: From baseline to the third month
Changes in the DMR/SMR ratio
To determine changes in the DMR/SMR ratio under scotopic, mesopic, photopic, and post-dilation conditions.
Measured: From baseline to the third month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (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.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohsen Pourazizi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohsen Pourazizi, Isfahan University of Medical Sciences
- Investigators
- Mohsen Pourazizi, Study director, Isfahan University of Medical Sciences, Feiz Hospital, Isfahan Isfahan, Isfahan, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743034
- Sponsor's protocol ID
- IR.ARI.MUI.REC.1405.118
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 3 Aug 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 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Tamsulosin and Silodosin on Anatomical Iris Changes in Patients With Benign Prostatic Hyperplasia: A Single-blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07743034
- Acronym / sponsor ID
- IR.ARI.MUI.REC.1405.118
- Conditions
- Benign Prostatic Hyperplasia, Tamsulosin, Silodosin, Intraoperative Floppy Iris Syndrome, Tomography, Optical Coherence, Iris Diseases
- Keywords
- Benign Prostatic Hyperplasia, Tamsulosin, Intraoperative Floppy Iris Syndrome, Tomography, Optical Coherence, Iris, Silodosin, IFIS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mohsen PouraziziUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 3 Aug 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.
Inhibition of alpha-1 adrenergic receptors by drugs such as tamsulosin and silodosin, which are prescribed for the treatment of benign prostatic hyperplasia, can lead to intraoperative floppy iris syndrome (IFIS) during cataract surgery. IFIS is a phenomenon characterized by a small, poorly dilating pupil and causes surgical difficulty.
Main objective: To determine and compare changes in the anatomical structure of the iris in patients with BPH before and after treatment with tamsulosin and silodosin.
Men aged 50 years and older with a definitive diagnosis of BPH who have no prior history of alpha-blocker use will be enrolled in one of the two treatment arms - tamsulosin or silodosin. Imaging will be performed using an MS-39 device (manufactured by CSO, Italy); assessments will be conducted at two time points - before the start of treatment and after three months of continuous drug use. At baseline and three months after treatment, using AS-OCT, the DMR and SMR regions and other ocular angle indices will be measured. Medication adherence will be assessed by counting the capsules used by each patient.
Specific Objectives:
- To determine changes in the dilator muscle region (DMR) under scotopic, mesopic, photopic, and post-dilation conditions from baseline to the third month in the tamsulosin \& silodosin groups and compare them.
- To determine changes in SMR under scotopic, mesopic, photopic, and post-dilation conditions from baseline to the third month in the tamsulosin \& silodosin groups and compare them.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Tamsulosin | Active comparator | Drug: tamsulosin 0.4mgTamsulosin 0.4 mg, daily. |
| Group 2: Silodosin | Active comparator | Drug: Silodosin 8 mgSilodosin 8 mg, daily. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men ≥ 50 years old with a definitive diagnosis of BPH by a urologist colleague.
- Patients with moderate symptoms based on the International Prostate Symptom Score (IPSS): score 8 to 19
- No prior use of alpha-blockers (tamsulosin, silodosin, doxazosin, etc.)
- Satisfactory vision for imaging and acceptable scan quality according to device criteria.
- Consent to participate in the study
Key exclusion criteria (9 listed)
- Insufficient image quality in assessments
- History of intraocular surgery
- Uncontrolled hypertension
- Iris trauma
- Patient unwillingness to continue participation in the study
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 |
|---|---|---|
| tamsulosin 0.4mgTamsulosin 0.4 mg, daily. | Drug | Group 1: Tamsulosin |
| Silodosin 8 mgSilodosin 8 mg, daily. | Drug | Group 2: Silodosin |
Primary outcome
Changes in the dilator muscle region (DMR)
Time frame: From baseline to the third month.
To determine changes in the DMR under scotopic, mesopic, photopic, and post-dilation conditions.
Changes in the sphincter muscle region (SMR)
Time frame: From baseline to the third month
To determine changes in the SMR under scotopic, mesopic, photopic, and post-dilation conditions.
Changes in the DMR/SMR ratio
Time frame: From baseline to the third month
To determine changes in the DMR/SMR ratio under scotopic, mesopic, photopic, and post-dilation conditions.
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 3 Aug 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.
Mohsen Pourazizi study director
Isfahan University of Medical Sciences, Feiz Hospital, Isfahan Isfahan, Isfahan, Iran
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tamsulosin 0.4mg and Silodosin 8 mg in people with Benign Prostatic Hyperplasia and Tamsulosin, run by Mohsen Pourazizi.
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 5 inclusion and 9 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 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Mohsen Pourazizi, Assistant Professor (98 + 09379578055, m.pourazizi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the dilator muscle region (DMR) (time frame: From baseline to the third month.). The study lists 3 primary outcomes in all. 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 3 Aug 2026.