Iris Structural Changes With Tamsulosin vs. Silodosin in Benign Prostatic Hyperplasia Patients
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Mohsen Pourazizi, Assistant Professor
- Phone Number: 98 + 09379578055
- Email: m.pourazizi@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Incorrect medication adherence during the study
- Diabetes
- Hypertension
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group 1: Tamsulosin
Tamsulosin 0.4 mg, daily.
|
Tamsulosin 0.4 mg, daily.
|
|
Active Comparator: Group 2: Silodosin
Silodosin 8 mg, daily.
|
Silodosin 8 mg, daily.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From baseline to the third month.
|
|
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.
|
From baseline to the third month
|
|
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.
|
From baseline to the third month
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mohsen Pourazizi, Isfahan University of Medical Sciences, Feiz Hospital, Isfahan Isfahan, Isfahan, Iran
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Male
- Prostatic Diseases
- Male Urogenital Diseases
- Eye Diseases
- Uveal Diseases
- Prostatic Hyperplasia
- Iris Diseases
- Sulfur Compounds
- Organic Chemicals
- Hydrocarbons
- Hydrocarbons, Cyclic
- Hydrocarbons, Aromatic
- Amides
- Benzene Derivatives
- Benzenesulfonamides
- Sulfonamides
- Sulfones
- Tamsulosin
- silodosin
Other Study ID Numbers
- IR.ARI.MUI.REC.1405.118
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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