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.
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.
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.
Parallel
Tamsulosin 0.4 mg + Tadalafil 2.5 mg
DrugPatients will receive Tamsulosin 0.4 mg once daily + Tadalafil 2.5 mg once daily
Tamsulosin 0.4 mg + Tadalafil 5 mg
DrugPatients will receive Tamsulosin 0.4 mg once daily + Tadalafil 5 mg once daily
Tamsulosin 0.4 mg
DrugPatients will receive Tamsulosin 0.4 mg once daily (monotherapy)
Mean change in International Prostate Symptom Score (IPSS) score
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
Incidence of adverse events
Incidence of adverse events related to Tamsulosin such as dizziness, orthostatic hypotension, headache, fatigue, nasal congestion, retrograde ejaculation, and gastrointestinal disturbances will be recorded.
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