A Systematic Review and Meta-analysis on the Use of Phosphodiesterase 5 Inhibitors Alone or in Combination with α-Blockers for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia

Context: Several randomized controlled trials (RCTs) on phosphodiesterase type 5 inhibitors (PDE5-Is) have showed significant improvements in both lower urinary tract symptoms (LUTS) and erectile dysfunction (ED) in men affected by one or both conditions, without a significant increase in adverse events. However, the results are inconsistent. Objective: Perform a systematic review and meta-analysis of available prospective and cross-sectional studies on the use of PDE5-Is alone or in combination with alpha 1-adrenergic blockers in patients with LUTS/benign prostatic hyperplasia (BPH). Evidence acquisition: A systematic search was performed using the Medline, Embase, and Cochrane Library databases through September 2011 including the combination of the following terms: LUTS, BPH, PDE5-Is, sildenafil, tadalafil, vardenafil, udenafil, alpha-blockers, and alpha 1-adrenergic blocker. The meta-analysis was conducted according to the guidelines for observational studies in epidemiology. Evidence synthesis: Of 107 retrieved articles, 12 were included in the present meta-analysis: 7 on PDE5-Is versus placebo, with 3214 men, and 5 on the combination of PDE5-Is with alpha 1-adrenergic blockers versus alpha 1-adrenergic blockers alone, with 216 men. Median follow-up of all RCTs was 12 wk. Combining the results of those trials, the use of PDE5-Is alone was associated with a significant improvement of the International Index of Erectile Function (IIEF) score (+5.5; p < 0.0001) and International Prostate Symptom Score (IPSS) (-2.8; p < 0.0001) but not the maximum flow rate (Q(max)) (-0.00; p = not significant) at the end of the study as compared with placebo. The association of PDE5-Is and alpha 1-adrenergic blockers improved the IIEF score (+3.6; p < 0.0001), IPSS score (-1.8; p = 0.05), and Q(max) (+1.5; p < 0.0001) at the end of the study as compared with alpha-blockers alone. Conclusions: The meta-analysis of the available cross-sectional data suggests that PDE5-Is can significantly improve LUTS and erectile function in men with BPH. PDE5-Is seem to be a promising treatment option for patients with LUTS secondary to BPH with or without ED. (C) 2012 European Association of Urology. Published by Elsevier B. V. All rights reserved.