Data support utility of sexual function questionnaire

April 1, 2008

Outcomes with a new sexual function questionnaire correlate well with validated measures of psychosocial function, patient satisfaction, erection hardness, erectile function, and sexual function.

Known as the Sexual Experience Questionnaire (SEX-Q), the instrument was evaluated in a randomized, double-blind clinical trial of treatment for erectile dysfunction.

"Filling out all of those questionnaires is a process that can become burdensome, and, as patients grow tired with the task, they lose their enthusiasm and motivation," he said.

"With just 12 items, the SEX-Q can be easily and quickly completed by patients. Based on its simplicity and validated performance, I believe practicing urologists will find it has good utility in patient care for obtaining accurate information about the broad aspects of sexual health."

The multicenter study included 209 men with ED who were randomized 1:1 to treatment with flexible-dose sildenafil citrate (Viagra), 50 or 100 mg, or placebo taken as needed for sexual activity up to once a day. Eligible patients were age 18 years and older with a diagnosis of ED based on a score of 25 or less on the International Index of Erectile Function-Erectile Function (IIEF-EF) domain. They also had to be in a stable sexual relationship for at least 6 months and have a history of using no phosphodiesterase type-5 inhibitors during the prior 6 months and no more than a total of six doses previous to that.

The participants in the trial had a mean age of about 52 years (range, 20 to 76), were predominantly Caucasian (~80%), and had a mean ED duration of just over 4 years. At baseline and after the 10-week double-blind treatment period, all men completed the SEX-Q and four other questionnaires: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS); Self-Esteem and Relationship (SEAR) (assessing self-esteem, confidence, and relationship satisfaction); Quality of Erection Questionnaire (QEQ) (assessing satisfaction with erection quality); and IIEF. The statistical analyses compared changes from baseline between treatment groups in the scores of the various questionnaires and correlations between changes in the total and individual domain SEX-Q scores and those measured in the other validated questionnaires.

The results showed significantly greater improvement from baseline in the SEX-Q scores among men in the sildenafil group compared to the controls. Significantly greater changes in the sildenafil group were also measured in the QEQ and SEAR questionnaires, and a significantly higher proportion of men treated with sildenafil were satisfied with their treatment than in the placebo group, according to the EDITS. All components of the IIEF, except for the Sexual Desire domain, also improved significantly more in the sildenafil group compared with controls.

The correlation analyses showed statistically significant correlations between the changes in the SEX-Q scores and the other outcomes questionnaires for all comparisons (p<.001); r values ranged from 0.46 to 0.87, and most were 0.7 or higher.

The research was supported by Pfizer. Dr. Jones has received research grants from Pfizer, but has no other financial interest in the company.