Combination of alfuzosin and sildenafil is superior to monotherapy in treating lower urinary tract symptoms and erectile dysfunction.

OBJECTIVES: This pilot study was undertaken to assess the efficacy and safety of the alpha(1)-blocker alfuzosin 10mg once daily (OD), the PDE-5 inhibitor sildenafil 25mg OD, and the combination of both on lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) and erectile dysfunction (ED).

MATERIAL AND METHODS: Men aged 50-76 yr with previously untreated LUTS and ED were randomized to receive alfuzosin (n=20), sildenafil (n=21), or the combination of both (n=21) for 12 wk. Changes from baseline in International Prostate Symptom Score (IPSS), voiding diary, maximum urinary flow rate (Qmax), postvoid residual urine (PVRU) volume, and erectile function domain of the International Index of Erectile Function (IIEF) were assessed at week 12.

RESULTS: Improvement of IPSS was significant with the three treatments but greatest with the combination (-24.1%) compared with alfuzosin (-15.6%) and sildenafil (-11.8%) [corrected] alone (p<0.03). Frequency, nocturia, PVR, and Qmax were significantly improved with alfuzosin only and the combination. Improvement in IIEF was slight with alfuzosin (16.7%), marked with sildenafil (49.7%), and greatest with the combination (58.6%). Likewise, increases in the frequency of penetration (Q3) and of maintained erection (Q4) were greater with the combination therapy (65.2% and 68.2%, respectively) than with sildenafil (41.7% and 59.1%, respectively) and alfuzosin (27.3% and 33.3%, respectively) alone. All three treatments were well tolerated.

CONCLUSIONS: In this pilot study, the combination of alfuzosin 10 mg OD and sildenafil 25 mg OD is safe and more effective than monotherapy with either agent to improve both voiding and sexual dysfunction in men with LUTS suggestive of BPH.