Silodosin vs Tamsulosin for LUTS Due to BPH: A Randomized Crossover Trial

March 12, 2026 updated by: Ahmed Mokhtar kamal mustafa, Ain Shams University

: 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?

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 11566
        • Ain Shams University Hospitals, Urology Outpatient Clinic
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Silodosin followed by Tamsulosin
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.
Drug: Silodosin
Silodosin 8 mg oral capsule administered once daily for 4 weeks during the assigned treatment period.
Drug: Tamsulosin
Tamsulosin 0.4 mg oral capsule administered once daily for 4 weeks during the assigned treatment period.
Active Comparator: Tamsulosin followed by Silodosin
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.
Drug: Silodosin
Silodosin 8 mg oral capsule administered once daily for 4 weeks during the assigned treatment period.
Drug: Tamsulosin
Tamsulosin 0.4 mg oral capsule administered once daily for 4 weeks during the assigned treatment period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 4, and Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Postvoid Residual Urine Volume
Time Frame: Baseline, Week 4, and Week 8
Change in postvoid residual urine volume measured by pelvi-abdominal ultrasound from baseline to the end of each 4-week treatment period.
Baseline, Week 4, and Week 8
Change in Peak Urinary Flow Rate
Time Frame: Baseline, Week 4, and Week 8
Change in peak urinary flow rate (Qmax) measured by uroflowmetry from baseline to the end of each 4-week treatment period.
Baseline, Week 4, and Week 8
Incidence of Ejaculatory Dysfunction
Time Frame: Throughout Week 1 to Week 8
Number of participants reporting ejaculatory dysfunction during each treatment period.
Throughout Week 1 to Week 8
Incidence of Dizziness
Time Frame: Baseline to Week 4 and Week 4 to Week 8
Number of participants reporting dizziness during each treatment period.
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
Number of participants reporting or developing hypotension during each treatment period.
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
Number of participants reporting ejaculatory dysfunction during each treatment period.
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
Number of participants reporting gastrointestinal adverse events during each treatment period.
Baseline to Week 4 and Week 4 to Week 8
Change in Quality of Life Score
Time Frame: Baseline, Week 4, and Week 8
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.
Baseline, Week 4, and Week 8
Change in International Index of Erectile Function-5 Score
Time Frame: Baseline, Week 4, and Week 8
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.
Baseline, Week 4, and Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 22, 2026

Primary Completion (Estimated)

September 22, 2026

Study Completion (Estimated)

October 22, 2026

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MS 151/2026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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