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

Sponsor
Ain Shams University
Study ID
NCT07722884
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tamsulosin 0.4 mg + Tadalafil 2.5 mg — DRUG
    Patients will receive Tamsulosin 0.4 mg once daily + Tadalafil 2.5 mg once daily
  • Tamsulosin 0.4 mg + Tadalafil 5 mg — DRUG
    Patients will receive Tamsulosin 0.4 mg once daily + Tadalafil 5 mg once daily
  • Tamsulosin 0.4 mg — DRUG
    Patients will receive Tamsulosin 0.4 mg once daily (monotherapy)

Study Details

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.

Key Dates

First listed
Jul 23, 2026
Start date
Jul 1, 2026
Status verified
Jul 2026
Primary completion
Jan 1, 2027
Completion
Jan 1, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A
    Patients will receive Tamsulosin 0.4 mg once daily + Tadalafil 2.5 mg once daily
  • Experimental: Group B
    Patients will receive Tamsulosin 0.4 mg once daily + Tadalafil 5 mg once daily
  • Experimental: Group C
    Patients will receive Tamsulosin 0.4 mg once daily (monotherapy)

Primary Outcome Measure

Mean change in International Prostate Symptom Score (IPSS) score [ Time Frame: 12 weeks post-procedure ]

Central Contacts

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