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Randomized Controlled Trial
. 2008 Mar;5(3):726-34.
doi: 10.1111/j.1743-6109.2007.00701.x. Epub 2007 Dec 17.

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

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Randomized Controlled Trial

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

Ates Kadioglu et al. J Sex Med. .

Abstract

Introduction: Erectile dysfunction (ED) impacts erection hardness and compromises quality of life.

Aim: 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).

Main outcome measures: 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.

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