Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07467343

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urogenital Diseases Urological Manifestations

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams University Hospitals, Urology Outpatient Clinic

Cairo, 11566, Egypt

Location contact

Ahmed Kamal Mokhtar, MBBCh

CONTACT

[email protected]

01200271186 ext. +20

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Silodosin

Drug

Silodosin 8 mg oral capsule administered once daily for 4 weeks during the assigned treatment period.

Tamsulosin

Drug

Tamsulosin 0.4 mg oral capsule administered once daily for 4 weeks during the assigned treatment period.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Incidence of Ejaculatory Dysfunction

    Time frame: Throughout Week 1 to Week 8

    Number of participants reporting ejaculatory dysfunction during each treatment period.

  6. Incidence of Dizziness

    Time frame: Baseline to Week 4 and Week 4 to Week 8

    Number of participants reporting dizziness during each treatment period.

  7. 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.

  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.

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed M Kamal, MBBCh

CONTACT

[email protected]

01200271186 ext. +02

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.