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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

Tamsulosin 0.4 mg: Patients will receive Tamsulosin 0.4 mg once daily (monotherapy)

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.

Eligibility

Primary outcome measure(s)

• Mean change in International Prostate Symptom Score (IPSS) score — 12 weeks post-procedure
  The International Prostate Symptom Score (IPSS) is an 8-question survey used to evaluate and track the severity of lower urinary tract symptoms, often linked to an enlarged prostate (BPH). Scores range from 0 to 35 based on symptom frequency, with a higher number indicating greater severity. The score evaluates symptoms into the following categories: 0 to 7 points: Mild symptoms 8 to 19 points: Moderate symptoms 20 to 35 points: Severe symptoms

Trial sites (1)

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