Aim: To compare the efficacy and safety of Tamsulosin–Tadalafil combination therapy with Tamsulosin monotherapy in patients with symptomatic BPH.

Study design: A comparative prospective study

Place and duration of study: This hospital-based comparative prospective study was conducted in the Department of Surgery at SGRDIMSR tertiary care teaching hospital, Amritsar from July 2024 to December 2025. 

Methodology: In this prospective comparative study, 150 men with BPH were assigned to either Tamsulosin–Tadalafil combination therapy or Tamsulosin monotherapy (75 patients per group). Treatment efficacy was evaluated using IPSS, Qmax, and PVRU over a 30-day follow-up period, along with safety and quality-of-life assessments.

Results: Baseline demographic and clinical characteristics were comparable between the groups. By Day 30, the combination therapy group demonstrated significantly greater improvement in all outcome measures. Mean IPSS decreased from 22.77±3.53 to 12.26±2.40 compared with 22.86±3.62 to 16.74±2.80 in the monotherapy group (p<0.001). Qmax increased from 9.75±1.62 to 13.96±1.58 mL/s versus 9.48±1.77 to 11.78±1.81 mL/s (p<0.001). PVRU decreased from 94.10±27.34 to 50.68±19.33 mL compared with 97.09±30.50 to 70.25±26.37 mL (p<0.001). Percentage improvement was significantly greater with combination therapy for IPSS (46.16% vs. 26.77%), Qmax (43.18% vs. 24.26%), and PVRU (46.14% vs. 27.64%) (all p<0.001). Adverse events were mild and comparable between groups. QoL scores were significantly better in the combination therapy group (1.8 vs. 2.6; p=0.001).

Conclusion: Tamsulosin–Tadalafil combination therapy provides significantly greater symptomatic and functional improvement than Tamsulosin monotherapy in men with BPH, without a meaningful increase in adverse effects. The combination regimen represents an effective and well-tolerated treatment option for patients with moderate-to-severe LUTS secondary to BPH.