Quality of erections in men treated with flexible-dose sildenafil for erectile dysfunction: multicenter trial with a double-blind, randomized, placebo-controlled phase and an open-label phase.
BACKGROUND
Erectile dysfunction (ED) impacts erection hardness and compromises quality of life.


OBJECTIVE
Assess erection hardness and its correlation with sexual function, emotional well-being, and satisfaction (erection quality, intercourse, sex life, sexual relationship, and treatment).


METHODS
Men with ED were randomized to double-blind, flexible-dose sildenafil (25, 50, or 100 mg) or placebo (6 weeks) with open-label extension (6 weeks).


METHODS
Erection Hardness Score (EHS), Quality of Erection Questionnaire (QEQ), International Index of Erectile Function (IIEF), Self-Esteem And Relationship (SEAR) questionnaire, and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS).


RESULTS
A total of 307 men (mean [range] age, 45 [18-55] years) were randomized to sildenafil (N = 154) or placebo (N = 153). At the end of double-blind treatment, occasions with EHS 3 (hard enough for penetration but not completely hard) or 4 (completely hard) had increased by 40% +/- 3% for sildenafil vs. 11% +/- 3% for placebo (least squares mean +/- standard error; P < 0.0001); the estimated percentage of occasions with EHS 4 was 58% (95% CI, 52-65%) vs. 14% (95% CI, 10-19%) (odds ratio, 8.5; P < 0.0001). There was greater improvement in mean QEQ, IIEF, and SEAR scores (P < 0.0001), and more men were satisfied with sildenafil treatment (EDITS Index score >50: 90% vs. 49%). QEQ, IIEF, SEAR, and EDITS outcomes correlated positively with EHS 3 or 4, and with EHS 4 alone and were highest (no overlap of 95% CI vs. other EHS subgroups) in the subgroup with most frequent EHS of 4.


CONCLUSIONS
In the group of men with ED treated with sildenafil, it was estimated that completely hard erections were achieved on 58% (95% CI, 52-65%) of occasions. Improvement in function, emotional well-being, and satisfaction was greatest in men with completely hard erections and correlated positively with other measures of hardness.
Kadioglu
Ates
A
Section of Andrology, Department of Urology, University of Istanbul, Istanbul, Turkey. itfabd@istanbul.edu.tr
Grohmann
Walther
W
Depko
Andrzej
A
Levinson
Ivan P
IP
Sun
Franklin
F
Collins
Suzanne
S
D000328:Adult; D016001:Confidence Intervals; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000523:psychology; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D017060:Patient Satisfaction / Q000706:statistics & numerical data*; D010410:Penile Erection / Q000187:drug effects* / Q000523:psychology; D010726:Phosphodiesterase Inhibitors / Q000627:therapeutic use*; D010879:Piperazines / Q000627:therapeutic use*; D011687:Purines / Q000627:therapeutic use; D011788:Quality of Life; D015203:Reproducibility of Results; D000068677:Sildenafil Citrate; D013450:Sulfones / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D011687:Purines; D013450:Sulfones; D000068677:Sildenafil Citrate