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

NCT07467343 | Not Yet Recruiting Phase 4

• 1 other identifier: FMASU MS 151/2026
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Keywords

Silodosin; Tamsulosin; Alpha-1 Adrenergic Antagonists; Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms; International Prostate Symptom Score; Uroflowmetry; Postvoid Residual Urine

Outcome Measures

Primary Outcomes (1)

• Change in International Prostate Symptom Score

  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 Outcomes (9)

• Change in Postvoid Residual Urine Volume

  Baseline, Week 4, and Week 8

• Change in Peak Urinary Flow Rate

  Baseline, Week 4, and Week 8

• Change in Quality of Life Score

  Baseline, Week 4, and Week 8

• Change in International Index of Erectile Function-5 Score

  Baseline, Week 4, and Week 8

• Incidence of Ejaculatory Dysfunction

  Throughout Week 1 to Week 8

Study Arms (2)

Silodosin followed by Tamsulosin

ACTIVE COMPARATOR

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; Drug: Tamsulosin

Tamsulosin followed by Silodosin

ACTIVE COMPARATOR

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; Drug: Tamsulosin

Interventions

Silodosin DRUG

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

Silodosin followed by Tamsulosin; Tamsulosin followed by Silodosin

Tamsulosin DRUG

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

Silodosin followed by Tamsulosin; Tamsulosin followed by Silodosin

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals, Urology Outpatient Clinic

Cairo, 11566, Egypt

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Interventions

silodosin; Tamsulosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Central Study Contacts

Ahmed M Kamal, MBBCh

CONTACT

01200271186; Ahmed.mukhtar@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Urology

Model Details: Participants will be randomized in a 1:1 ratio to one of two treatment sequences in a 2-period crossover design. Sequence A will receive silodosin 8 mg once daily for 4 weeks followed by tamsulosin 0.4 mg once daily for 4 weeks. Sequence B will receive tamsulosin 0.4 mg once daily for 4 weeks followed by silodosin 8 mg once daily for 4 weeks. Efficacy and safety outcomes will be assessed at baseline, week 4, and week 8.

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 12, 2026
• Study Start: March 22, 2026
• Primary Completion (Estimated): September 22, 2026
• Study Completion (Estimated): October 22, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

EG (1)