A multicenter, double-blind, placebo-controlled trial to assess the efficacy of sildenafil citrate in men with unrecognized erectile dysfunction.

OBJECTIVE: Erectile dysfunction (ED) may be present but unrecognized in men with other comorbidities, such as cardiovascular disease (CVD), diabetes, or lower urinary tract symptoms (LUTS). The efficacy of sildenafil citrate treatment for ED in men who did not self-identify with or were unsure about whether they had ED, but had ED based on International Index of Erectile Function Erectile Function domain (IIEF-EF) scores, was evaluated.

METHODS: Men with an ED-associated comorbidity were asked, "Do you have ED?" Those who answered "no" or "unsure" and were diagnosed with ED (score of <or=25 IIEF-EF) were invited to participate in a parallel-group, multicenter, flexible-dose, double-blind, randomized, placebo-controlled trial, followed by an open-label extension. Erectile function and emotional/psychosocial benefits of sildenafil treatment were assessed.

RESULTS: Men with ED at baseline were randomized to sildenafil (n = 150) or placebo (n = 155). The mean +/- SD number of ED risk factors in the sildenafil and placebo groups was 3.5 +/- 1.8 and 3.3 +/- 1.7, respectively. Hypertension, hypercholesterolemia, smoking, obesity (body mass index >or=30 kg/m(2)), and waist circumference >or=40 inches were the most frequently reported risk factors. Sildenafil-treated men had improved scores on both functional and psychosocial measures. Most adverse events were mild to moderate.

CONCLUSIONS: Many men do not recognize that they have ED; sildenafil treatment improved sexual function and satisfaction in these men. Because ED affects quality of life, it should be suspected and assessed in men with risk factors for ED.