Effect of sildenafil citrate on the male sexual experience assessed with the Sexual Experience Questionnaire: a multicenter, double-blind, placebo-controlled trial with open-label extension.

INTRODUCTION: The Sexual Experience Questionnaire (SEX-Q) enables quick and easy assessment of functional, emotional, and satisfaction-related aspects of the sexual experience in men with erectile dysfunction (ED).

AIM: To assess correlations between improvement on the SEX-Q and outcomes on other validated questionnaires. METHODS. Men with ED (score < or =25 on the Erectile Function domain of the International Index of Erectile Function [IIEF]) who had used less than or equal to six doses of any phosphodiesterase 5 inhibitor (none within 6 months) were randomized to 10 weeks of double-blind, placebo-controlled (DBPC) flexible-dose sildenafil citrate (50 or 100 mg, as needed), followed by 6 weeks of open-label (OL) sildenafil.

MAIN OUTCOME MEASURES: SEX-Q, IIEF, Quality of Erection Questionnaire (QEQ), Self-Esteem and Relationship (SEAR) Questionnaire, Erection Hardness Score (EHS), successful intercourse attempts (SIAs), Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), and global efficacy questions (GEQs).

RESULTS: Compared with the placebo group (N = 105), the sildenafil group (N = 104) at DBPC end of treatment (EOT) had significantly more improvement (P < 0.05) on all SEX-Q, IIEF (except the Sexual Desire domain), QEQ, and SEAR outcomes, more frequent SIAs and EHS 3 (hard enough for penetration but not completely hard) or EHS 4 (completely hard) erections (odds ratio [OR], 2.52 and 3.46, respectively), EHS 4 erections four times as often (OR, 6.41), more men satisfied with treatment (EDITS; OR, 2.6), approximately twice as many men with improved erections (GEQ1; OR, 5.8) and ability to have sexual intercourse (GEQ2; OR, 5.4), and GEQ3 scores that indicated better sex (P < 0.0001). SEX-Q score improvements correlated positively with all other outcomes. At OL EOT, most outcomes were >60% (and approximately half were > or =80%) of the maximum positive result.

CONCLUSIONS: SEX-Q change scores correlate with several other functional, emotional, and satisfaction-related outcomes in men treated with sildenafil for ED, allowing a simple and focused evaluation of the sexual experience.