Abstract Introduction Benign prostatic hyperplasia (BPH) is a prevalent condition in aging men, frequently associated with both lower urinary tract symptoms (LUTS) and erectile dysfunction (ED). The shared pathophysiological pathways between BPH and ED have led to the exploration of phosphodiesterase type 5 (PDE5) inhibitors and alpha-blockers as therapeutic options. However, the comparative efficacy of combination therapy versus monotherapy requires further elucidation. Objective The objective of this study was to compare the efficacy and safety of a fixed-dose combination of Tadalafil 5 mg plus Tamsulosin 0.4 mg versus monotherapy with either agent in men with concurrent BPH-related LUTS and ED. Methods This prospective, randomized clinical trial included 140 men aged 45 years with LUTS secondary to BPH and concomitant ED. Participants were randomized into three groups for a 12-week treatment period: Group I received Tamsulosin 0.4 mg/day (n=44), Group II received Tadalafil 5 mg/day (n=47), and Group III received a daily combination of Tamsulosin 0.4 mg and Tadalafil 5 mg (n=49). Efficacy was assessed using the International Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax), post-void residual urine (PVRU), and the International Index of Erectile Function (IIEF-5). Results After 12 weeks, the combination therapy group (Group III) demonstrated a significantly greater median percentage improvement in IPSS compared to both Tamsulosin alone (Group I) and Tadalafil alone (Group II) (-12.4% vs. -8.7% vs. -2.6%, respectively; p0.001). The median increase in Qmax was also greatest in the combination group (41.0%) compared to the Tamsulosin (31.9%) and Tadalafil (4.5%) monotherapy groups (p0.001). Similarly, PVRU showed the largest median reduction with combination therapy (-75% vs. -42% for Tamsulosin and -32% for Tadalafil; p0.001). For erectile function, the combination group and Tadalafil alone group showed significant and comparable median improvements in IIEF-5 scores (35.8% and 34.1%, respectively), both of which were vastly superior to Tamsulosin alone (0.1%; p0.001). The treatments were well tolerated, with no significant differences in adverse events across the groups. Conclusions Fixed-dose combination therapy with Tadalafil and Tamsulosin demonstrated superior efficacy in improving both lower urinary tract symptoms and objective urinary flow measures compared to monotherapy with either agent. It also provided significant improvement in erectile function, comparable to Tadalafil alone. These findings support the use of combination therapy as a preferred, highly effective, and well-tolerated treatment strategy for men with co-existing LUTS and ED. Disclosure No
Mohammed et al. (Mon,) studied this question.
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