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Tamsulosin Monotherapy Versus Combination Therapy With Tadalafil (2.5 mg vs 5 mg) in Managing Male LUTS Secondary to BPH

NCT07722884 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-07-23

No results posted yet for this study

Summary

This study aims to evaluate the short-term impact and clinical outcomes of tamsulosin monotherapy versus combination therapy with tamsulosin plus tadalafil (2.5 mg vs. 5 mg) on lower urinary tract symptoms (LUTS) severity and patient quality of life in men with benign prostatic hyperplasia (BPH). It also seeks to determine whether the lower tadalafil dose provides adequate symptom relief while minimizing adverse effects over a 12-week follow-up period.

Conditions

  • Safety
  • Efficacy
  • Tamsulosin
  • Monotherapy
  • Tadalafil
  • Lower Urinary Tract Symptoms
  • Benign Prostatic Hyperplasia

Interventions

DRUG

Tamsulosin 0.4 mg + Tadalafil 2.5 mg

Patients will receive Tamsulosin 0.4 mg once daily + Tadalafil 2.5 mg once daily

DRUG

Tamsulosin 0.4 mg + Tadalafil 5 mg

Patients will receive Tamsulosin 0.4 mg once daily + Tadalafil 5 mg once daily

DRUG

Tamsulosin 0.4 mg

Patients will receive Tamsulosin 0.4 mg once daily (monotherapy)

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-01-01
Completion
2027-01-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07722884 on ClinicalTrials.gov