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


METHODS
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.


METHODS
Men > or = 18 years old with ED.


METHODS
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.
Althof
Stanley E
SE
Case Western Reserve University, Cleveland, OH, USA. sxa6@po.cwru.edu
O' Leary
Michael P
MP
Cappelleri
Joseph C
JC
Glina
Sidney
S
King
Rosie
R
Tseng
Li-Jung
LJ
Bowler
Jessica L
JL
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000523:psychology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000627:therapeutic use*; D011687:Purines; D012649:Self Concept; D012725:Sexual Behavior / Q000187:drug effects / Q000523:psychology*; D000068677:Sildenafil Citrate; D013450:Sulfones
D010879:Piperazines; D011687:Purines; D013450:Sulfones; D000068677:Sildenafil Citrate