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The aim of this study was to report and analyze the published data from randomized controlled trials (RCTs) for (i) the psychosocial outcomes associated with erectile dysfunction (ED) before treatment with a phosphodiesterase type 5 (PDE5) inhibitor; and (ii) the change in psychosocial outcomes after the use of a PDE5 inhibitor in men with ED.The method used was a prospectively designed systematic literature review of publications reported in MEDLINE via PubMed, EMBASE, the Cochrane Library, Science Citation Index Expanded, and PsychINFO from January 1, 1995 to May 14, 2012.The main outcome measures were scores on psychosocial measures in men who were treated for ED with a PDE5 inhibitor before and after treatment.A total of 1,714 publications were retrieved; 1,674 publications were excluded because they did not meet the design requirements of the review, and 40 publications (32 RCTs) were retained. Before treatment, men who participated in clinical trials reported relatively good quality of life and overall relationships, but poor sexual relationships and sexual satisfaction, diminished confidence, low self-esteem, and symptoms of depression. After treatment, there were significant improvements from baseline in most of these measures, except for overall life satisfaction and overall relationship satisfaction.ED and the treatment of ED are associated with substantially broader aspects of a man's life than just erectile functioning. This review demonstrates the importance of evaluating the psychosocial factors associated with ED and its treatment, and the importance of using standardized scales to conduct this evaluation. Further research is needed to better understand the mechanisms underlying the reciprocal relationships among physical and psychological functioning in men with ED.