O'leary MP, Althof SE, Cappelleri JC, Crowley A, Sherman N, Duttagupta S; The United States Self-Esteem and Relationship Questionnaire Study Group.

Department of Surgery, Harvard Medical School, and Division of Urology, Brigham and Women's Hospital, Boston, Massachusetts.

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 less than 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 less than 0.0001), other IIEF domain scores (p less than 0.0001), percentage of successful intercourse attempts (p less than 0.0001) and frequency of erection that allowed satisfactory intercourse (p less than 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.