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Not yet recruiting NCT07743034

Iris Structural Changes With Tamsulosin vs. Silodosin in Benign Prostatic Hyperplasia Patients

Phase IV Interventional Benign Prostatic Hyperplasia Tamsulosin Silodosin Intraoperative Floppy Iris Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: tamsulosin 0.4mg, Silodosin 8 mg.
Who it may be relevant to
Registry conditions: Benign Prostatic Hyperplasia, Tamsulosin, Silodosin, Intraoperative Floppy Iris Syndrome. Basic parameters: from 50 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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: 1. 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. 2. 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.

Interventions

  • Drug tamsulosin 0.4mg
    Tamsulosin 0.4 mg, daily.
  • Drug Silodosin 8 mg
    Silodosin 8 mg, daily.

Primary outcome measures

  • Changes in the dilator muscle region (DMR) [Time frame: From baseline to the third month.]
  • Changes in the sphincter muscle region (SMR) [Time frame: From baseline to the third month]
  • Changes in the DMR/SMR ratio [Time frame: From baseline to the third month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07743034 · IR.ARI.MUI.REC.1405.118

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗