Self-esteem, confidence, and relationships in men treated with sildenafil citrate for erectile dysfunction: results of two double-blind, placebo-controlled trials

Abstract

Background: Men with erectile dysfunction (ED) often have low self-esteem, confidence, and sexual relationship satisfaction.

Objective: We evaluated the impact of sildenafil citrate and its generalizability across cultures on self-esteem, confidence, and sexual relationship satisfaction in men with ED using the Self-Esteem And Relationship (SEAR) questionnaire.

Design: Pooled analysis of 2 double-blind, placebo-controlled, flexible-dose trials of sildenafil with identical protocols: 1 was conducted in the United States and the other in Mexico, Brazil, Australia, and Japan.

Patients: Men > or = 18 years old with ED.

Measurements: The impact of treatment on psychosocial factors associated with ED was determined by patient responses to the SEAR questionnaire. Erectile function was determined using the International Index of Erectile Function (IIEF) and a global efficacy question. Successful sexual intercourse attempts were derived from event logs of sexual activity. Treatment effect sizes were calculated for all study outcomes.

Results: Compared with patients who received placebo (n = 274), patients who received sildenafil (n = 279) reported significantly greater improvements (P < .0001) in self-esteem, confidence, sexual relationship satisfaction, and in all sexual function domains of the IIEF. Treatment effect sizes were large (range, 0.7 to 1.2) for all SEAR components, and improvement in psychosocial measures showed moderate to high correlations (range, 0.50 to 0.83, P < .0001) with improvement in erectile function, percentage of successful intercourse attempts, and global efficacy.

Conclusions: In men with ED from 5 different nations, sildenafil produced substantial improvements in self-esteem, confidence, and sexual relationship satisfaction. Improvements in these psychosocial factors were observed crossculturally and correlated significantly and tangibly with improvements in erectile function.

FIGURE 1

Mean change from baseline to end of treatment on SEAR components. Compared with patients who were randomized to receive placebo (n = 274, white bars), patients who were randomized to receive sildenafil (n = 279, gray bars) reported significantly higher scores on all components of the SEAR questionnaire. The height of the bars represents the mean, and the corresponding vertical line centered around the mean represents the 95% confidence interval (CI) within each treatment group. Difference in mean change between groups (95% CI) on SEAR components: Sexual Relationships domain, 22.9 (18.5 to 27.3); Confidence domain, 21.9 (17.3 to 26.6); Self-Esteem subscale, 22.5 (17.7 to 27.4); Overall Relationship subscale, 20.1 (14.9 to 25.2); Overall SEAR score, 22.4 (18.1 to 26.7). SEAR=Self-Esteem And Relationship questionnaire.^*P<.0001 compared with placebo.

FIGURE 2

Mean change from baseline to end of treatment in scores on IIEF domains. Compared with patients who were randomized to receive placebo (n = 274, white bars), patients who were randomized to receive sildenafil (n = 279, gray bars) reported significantly higher scores on all domains of the IIEF questionnaire. Domain items were summed, and higher scores indicated a more favorable response. The height of the bar represents the mean, and the corresponding vertical line centered around the mean represents the 95% confidence interval (CI) within each treatment group. Difference in mean change between groups (95% CI) on IIEF domains: Erectile Function, 6.2 (4.9 to 7.5); Orgasmic Function, 1.5 (1.1 to 2.0); Sexual Desire, 0.7 (0.4 to 1.0); Intercourse Satisfaction, 2.3 (1.7 to 2.8); Overall Satisfaction, 2.1 (1.7 to 2.6). IIEF, International Index of Erectile Function. ^*P<.0001 compared with placebo.