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Recruiting NCT07722884

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

No phase Interventional Safety Efficacy Tamsulosin Monotherapy

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 0.4 mg + Tadalafil 2.5 mg, Tamsulosin 0.4 mg + Tadalafil 5 mg, Tamsulosin 0.4 mg.
Who it may be relevant to
Registry conditions: Safety, Efficacy, Tamsulosin, Monotherapy. Basic parameters: from 45 years · All.
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
Egypt
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

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

Overview

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.

Detailed description

Lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) are a fundamental component of modern urology, affecting extensively aging men and significantly impacting their quality of life.

Tamsulosin monotherapy, is effective in the management of BPH by acting as an α₁-adrenergic receptor antagonist that relaxes smooth muscle in the prostate and bladder neck, thereby improving urinary flow and reducing LUTS.

The combination of tamsulosin 0.4 mg with tadalafil is commonly used as an effective option. It balances sufficient symptom relief with moderate side effect profile.

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)

Primary outcome measures

  • Mean change in International Prostate Symptom Score (IPSS) score [Time frame: 12 weeks post-procedure]
Secondary outcome measures (1)
  • Incidence of adverse events [Time frame: 12 weeks post-procedure]

Eligibility criteria

Inclusion criteria

  • Patients older than 45 years of age.
  • Clinical diagnosis of benign prostatic hyperplasia (BPH) and moderate to severe lower urinary tract symptoms (LUTS) \[International Prostate Symptom Score (IPSS) ≥ 13\].
  • Maximum flow rate (Qmax) ≤ 15 mL/s, prostate volume ≥ 30 mL by transrectal ultrasound.

Exclusion criteria

  • Patients taking α-blockers, beta-blockers, 5-alpha reductase inhibitors, phosphodiesterase-5 (PDE5) inhibitors, anticholinergics, or nitrates were excluded.
  • Patients with a history of prostate or bladder surgery, lower urinary tract procedures, prostate or bladder cancer, neurological conditions affecting bladder function, severe cardiovascular disease, hepatic impairment, diabetes mellitus with complications, kidney dysfunction (acute or chronic), neurogenic bladder, or congenital urinary anomalies.
  • Additionally, patients with recent myocardial infarction, unstable angina, severe heart failure, uncontrolled hypertension, Prostate-Specific Antigen (PSA)>4 ng/mL (unless cancer ruled out), active urinary tract infection, urinary retention, and those unavailable for follow-up were also excluded from the study.

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
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Ain Shams University — Cairo

Identifiers

NCT: NCT07722884 · FMASU MS 500/2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗