Analysis of single items on the Self-Esteem And Relationship questionnaire in men treated with sildenafil citrate for erectile dysfunction: results of two double-blind, placebo-controlled trials

OBJECTIVE To evaluate the effect of sildenafil citrate on each item of the 14-item Self-Esteem And Relationship (SEAR) questionnaire, which is used to measure self-esteem, confidence, satisfaction with sexual relationship, and overall relationship satisfaction in men with erectile dysfunction (ED). PATIENTS AND METHODS Data were combined from two 12-week, double-blind, placebo-controlled, flexible-dose sildenafil trials having identical protocols, one conducted in the USA and the other in Mexico, Brazil, Australia and Japan. All men had ED and were aged >= 18 years. Response categories of each SEAR item used a 4-week reference period and were based on a five-point scale (1, almost never/never; 2, a few times; 3, sometimes; 4, most times; 5, almost always/always). The difference (sildenafil vs placebo) in the change from baseline to week 12 was evaluated with a Wilcoxon rank sum test using ridit analysis, and an analysis of covariance model that included treatment group, centre, study and baseline item score. RESULTS Compared with the 274 patients receiving placebo, the 279 receiving sildenafil reported significantly greater mean and median improvements (P < 0.001) in each of the 14 SEAR items. The probability of increased psychosocial benefit from baseline to week 12 was higher with sildenafil for each SEAR item, and ranged from 0.60 ('My partner was unhappy with the quality of our sexual relations' [item reverse-scored]) to 0.72 ('I was satisfied with my sexual performance'). Across all items, the mean (SD) probability was 0.67 (0.04) that a randomly selected patient in the sildenafil group would have a more favourable change relative to a randomly selected patient in the placebo group. CONCLUSIONS Sildenafil produced substantial and meaningful improvements at the item-specific level. This analysis complements previously published work on self-esteem, confidence and relationship satisfaction.