A fixed dose combination of tamsulosin and tadalafil in men with benign prostatic hyperplasia and erectile dysfunction: a prospective, multicenter, phase IV study.

PURPOSE: To evaluate the safety and efficacy of a fixed-dose combination (FDC) of tamsulosin prolonged release (PR) and tadalafil in moderate-severe benign prostatic hyperplasia (BPH) and erectile dysfunction (ED).

METHODS

This was a single-arm, phase IV, prospective clinical trial in sexually active men aged 45–75 years with BPH [International Prostate Symptom Score (IPSS) score ≥ 8] and ED [International Index of Erectile Function-Erectile Function (IIEF-EF) score ≤ 25] who were taking tamsulosin 0.4 mg PR and tadalafil 5 mg. Eligible patients received FDC of tamsulosin+tadalafil (0.4 + 5 mg) capsules for 12 weeks. The endpoints included treatment-emergent adverse events (TEAEs), total IPSS, IPSS storage and voiding sub-scores, maximum urinary flow rate (Qmax), post-void residual (PVR) volume, IIEF-EF (questions 1–5 and 15) score, and IPSS quality of life (QoL) index.

RESULTS

A total of 172 were enrolled. Overall, 12 TEAEs were reported in 10 (5.81%) patients. None of the TEAEs were severe, serious, life-threatening, or required treatment interruption. A statistically significant improvement (p < 0.0001) in total IPSS after 4, 8, and 12 weeks was observed. Similar improvements from baseline were also observed in IPSS storage and voiding sub-scores, IPSS QoL, Qmax, PVR volume, and IIEF-EF (questions 1–5 and 15) score (p < 0.05 for each parameter). The proportion of men with normal erectile function significantly increased at week 12 (p = 0.0003).

CONCLUSION

The FDC of tamsulosin and tadalafil was associated with significant improvements in lower urinary tract symptoms and EF over 12 weeks and was well tolerated in Indian men with moderate-severe BPH and ED. TRIAL REGISTRATION: Prospectively registered at Clinical Trials Registry—India on 10th June 2022 [CTRI/2022/06/043152].