Self-Esteem, Confidence and Relationship Satisfaction of Men With Erectile Dysfunction Treated With Sildenafil Citrate: A Multicenter, Randomized, Parallel Group, Double-Blind, Placebo Controlled Study in the United States

Purpose

We assessed the change in confidence, relationships and self-esteem, and its correlation with erectile function in men with ED treated with sildenafil citrate in the first United States based, double-blind, placebo controlled, randomized trial assessed by the validated SEAR.

Materials and Methods

This 12-week flexible dose (25, 50 or 100 mg) trial determined change scores from baseline to end of treatment for the 5 SEAR components (Sexual Relationship domain, Confidence domain, Self-Esteem subscale [prespecified as the primary end point], Overall Relationship subscale and Overall score), and their correlations with the IIEF and event log data, as well as correlations between SEAR components and a general efficacy question at the end of treatment.

Results

Compared with the placebo group (125 patients, mean age ± SD 55 ± 13 years, mean years ED 3.8 ± 4.2), the sildenafil group (128 patients, mean age ± SD 56 ± 12, mean years ED 4.6 ± 4.3) had significantly greater improvements in all 5 SEAR components (p <0.0001) and all sexual function measures. SEAR component scores showed significant correlations with IIEF Erectile Function domain scores (r range 0.34 to 0.69, p <0.0001), other IIEF domain scores (p <0.0001), percentage of successful intercourse attempts (p <0.0001) and frequency of erection that allowed satisfactory intercourse (p <0.0001).

Conclusions

In this study of men with ED, sildenafil produced substantial improvements in self-esteem, confidence and relationship satisfaction as measured by SEAR scores, which showed moderate to high positive correlations with IIEF scores.

Key Words:  impotence , self concept , quality of life , psychometrics

Abbreviations and Acronyms:  CI, confidence interval , ED, erectile dysfunction , EF, erectile function , GEQ, global efficacy question , IIEF, International Index of Erectile Function , SD, standard deviation , SEAR, Self-Esteem And Relationship questionnaire