New Methodology for Comprehensively Assessing the Multidimensional Impact of Erectile Dysfunction Treatment on Couples.

New Methodology for Comprehensively Assessing the Multidimensional Impact of Erectile Dysfunction Treatment on Couples, William Fisher, University of Western Ontario; Raymond C. Rosen, Robert Wood Johnson Medical School; Martin Mollen, Arizona Research Center; Gerald Brock, St. Joseph's Medical Center, Canada; Gary Karlin, Lawrenceville Urology Practice; Peter Pommerville, Can-med Clinical Research Inc.; Irwin Goldstein, Boston University School of Medicine; Keith Bangerter, Bayer Healthcare Pharmaceuticals

Erectile dysfunction (ED) clinical research has traditionally focused on men's experiences of ED, and research concerning the female partners' experience of ED is limited. Prospective, randomized trials utilizing validated multidimensional tools to fully evaluate the impact of ED treatment on couples is still needed. In a 12-week double-blind, multicenter, flexible-dose, parallel-group study, men over 18 years of age with ED for at least 6 months were randomized to receive vardenafil or placebo. Erectile function was assessed by changes in patients' responses to the Sexual Encounter Profile question 3 (SEP3) "Did your erection last long enough for you to have sexual intercourse?," SEP2 ("Were you able to insert your penis into your partner's vagina?"), and the erectile function domain of the International Index of Erectile Function (IIEF-EF). The Erection Quality Scale (EQS), a new 15-item, self-report instrument, assesses five domains of erection quality: ability to get an erection, duration of erection, hardness of erection, pleasurable feelings, and general experience of erection quality, and was completed for exploratory purposes. Couples were asked to evaluate multiple aspects of their sexual satisfaction and quality of life (QOL) using the QOL domain of the modified Sexual Life Quality Questionnaire (mSLQQ-QOL). Treatment Satisfaction Scale (TSS), Subject Active Medication module, and Partner Active Medication module scores were recorded by both partners to determine satisfaction with treatment. Changes in patients' overall response rate to SEP3 and female partners' response to the mSLQQ-QOL at last observation carried forward (LOCF) were considered the primary efficacy measures. The integration of the scales we used into ED clinical trials may provide a deeper understanding of the complex impact of ED and the benefits of treatment.