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.
OBJECTIVE
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.


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.
Department of Surgery, Harvard Medical School, and Division of Urology, Brigham and Women's Hospital, Boston, Massachusetts 02115-6105, USA. moleary1@bics.bwh.harvard.edu
Michael P
MP
O'Leary
Stanley E
SE
Althof
Joseph C
JC
Cappelleri
Arthur
A
Crowley
Nancy
N
Sherman
Sandeep
S
Duttagupta
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003075:Coitus; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000523:psychology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010726:Phosphodiesterase Inhibitors / Q000627:therapeutic use*; D010879:Piperazines / Q000627:therapeutic use*; D011581:Psychological Tests; D011687:Purines; D012649:Self Concept; D000068677:Sildenafil Citrate; D013450:Sulfones; D011795:Surveys and Questionnaires; D014481:United States
D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D011687:Purines; D013450:Sulfones; D000068677:Sildenafil Citrate