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

Eur Urol. 2012 May;61(5):994-1003. doi: 10.1016/j.eururo.2012.02.033. Epub 2012 Feb 25.


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 α1-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, α-blockers, and α1-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 α1-adrenergic blockers versus α1-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 α1-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 α-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.

Publication types

  • Meta-Analysis
  • Review
  • Systematic Review

MeSH terms

  • Adrenergic alpha-Antagonists / therapeutic use*
  • Carbolines / therapeutic use
  • Drug Therapy, Combination
  • Erectile Dysfunction / drug therapy
  • Humans
  • Imidazoles / therapeutic use
  • Lower Urinary Tract Symptoms / drug therapy*
  • Male
  • Phosphodiesterase 5 Inhibitors / therapeutic use*
  • Piperazines / therapeutic use
  • Prostatic Hyperplasia / drug therapy*
  • Purines / therapeutic use
  • Pyrimidines / therapeutic use
  • Sildenafil Citrate
  • Sulfonamides / therapeutic use
  • Sulfones / therapeutic use
  • Tadalafil
  • Treatment Outcome
  • Triazines / therapeutic use
  • Vardenafil Dihydrochloride


  • Adrenergic alpha-Antagonists
  • Carbolines
  • Imidazoles
  • Phosphodiesterase 5 Inhibitors
  • Piperazines
  • Purines
  • Pyrimidines
  • Sulfonamides
  • Sulfones
  • Triazines
  • Vardenafil Dihydrochloride
  • Tadalafil
  • Sildenafil Citrate
  • udenafil