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.
O'Leary
Michael P
MP
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
Althof
Stanley E
SE
Cappelleri
Joseph C
JC
Crowley
Arthur
A
Sherman
Nancy
N
Duttagupta
Sandeep
S
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