Alfuzosin monotherapy versus alfuzosin plus tadalafil combination in young males with lower urinary tract symptoms secondary to benign prostatic hyperplasia
Abstract
Objectives: The objectives of the study are to compare the efficacy and safety of alfuzosin monotherapy with the combination of alfuzosin and tadalafil in young males (aged 30–60 years) presenting with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).
Methods: Ninety eligible males with moderate-to-severe LUTS (International Prostate Symptom Score [IPSS] ≥8) were randomly allocated to two groups at a tertiary care urology unit and followed for 12 months. Group A (n=45) received alfuzosin sustained-release (SR) 10 mg once daily, while Group B (n=45) received alfuzosin SR 10 mg plus tadalafil 5 mg once daily. Assessments at baseline, 3, 6, and 12 months included IPSS total score, maximum urinary flow rate (Qmax), post-void residual volume, International Index of Erectile Function-5 (IIEF-5), prostate volume by transrectal ultrasonography and adverse effects.
Results: Both groups demonstrated significant improvement from baseline in all primary outcome measures (p<0.001). At 12 months, the combination therapy group (Group B) showed superior reduction in total IPSS (18.9±3.4–8.1±2.3 vs. 18.6±3.2–11.2±2.8; p<0.001) and greater improvement in Qmax (9.6±1.9–15.9±2.7 mL/s vs. 9.8±2.1–13.6±2.4 mL/s; p<0.001). IIEF-5 score improvement was significantly better in Group B (15.9±4.1– 22.3±3.2 vs. 16.2±3.8–18.6±3.4; p<0.001). Adverse effects were mild and comparable between groups.
Conclusion: The combination of alfuzosin and tadalafil is significantly…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 45 participants or records.
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