Improving the sexual quality of life of couples affected by erectile dysfunction: a double-blind, randomized, placebo-controlled trial of vardenafil.
BACKGROUND
Erectile dysfunction (ED) has a dual negative impact on men and their female partners; both are likely to face a drop in sexual quality of life and challenges to their intimate relationship as couples' sexual activities are curtailed by the loss of erectile function.


OBJECTIVE
The primary objective of this study was to compare the efficacy of vardenafil vs. placebo in terms of success of maintenance of erection in men with ED and improvement of their female partner's sexual quality of life.


METHODS
This was a randomized, double-blind, multicenter, flexible-dose, parallel-group comparison of vardenafil vs. placebo for 12 weeks in men (> or =18 years) with ED of > or = 6 months duration, and their female partners.


METHODS
Changes in patient's overall response rate to Sexual Encounter Profile question 3 (SEP3) "Did your erection last long enough for you to have sexual intercourse?" and female partner's response to the quality of life domain of the modified Sexual Life Quality Questionnaire (mSLQQ-QOL) at last observation carried forward (LOCF) were considered the primary efficacy measures. In addition, patient's response to SEP2 "Were you able to insert your penis into your partner's vagina?," the erectile function domain of the International Index of Erectile Function (IIEF-EF) and patient's mSLQQ-QOL score were also assessed.


RESULTS
Compared with placebo, vardenafil significantly improved overall least square (LS) mean per-patient SEP3 success rate (28% vs. 68%; P < 0.0001) and partner's LS mean (standard error [SE]) mSLQQ-QOL score at LOCF (32.14 [3.24] vs. 65.80 [3.10]; P < 0.0001). In addition, compared with placebo, vardenafil also improved overall LS mean per-patient SEP2 success rate (47% vs. 80%; P < 0.0001), LS mean (SE) IIEF-EF scores at LOCF (12.7 [0.8] vs. 22.8 [0.8]; P < 0.0001) and patient's LS mean (SE) mSLQQ-QOL (28.37 [3.46] vs. 63.85 [3.28]; P < 0.0001) at LOCF.


CONCLUSIONS
Vardenafil improved erectile function in men with ED and improved the sexual quality of life of the couple.
Fisher
William A
WA
Department of Psychology, Social Science Centre 6430, University of Western Ontario, London, Ontario, Canada N6A 5C2. fisher@uwo.ca
Rosen
Raymond C
RC
Mollen
Martin
M
Brock
Gerald
G
Karlin
Gary
G
Pommerville
Peter
P
Goldstein
Irwin
I
Bangerter
Keith
K
Bandel
Tiemo-Joerg
TJ
Derogatis
Leonard R
LR
Sand
Michael
M
D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000503:physiopathology* / Q000523:psychology*; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010549:Personal Satisfaction; D010879:Piperazines / Q000627:therapeutic use*; D011788:Quality of Life / Q000523:psychology*; D012725:Sexual Behavior / Q000523:psychology*; D012747:Sexual Partners / Q000523:psychology*; D013450:Sulfones / Q000627:therapeutic use; D011795:Surveys and Questionnaires; D014227:Triazines / Q000627:therapeutic use; D000069058:Vardenafil Dihydrochloride; D014665:Vasodilator Agents / Q000627:therapeutic use*
D007093:Imidazoles; D010879:Piperazines; D013450:Sulfones; D014227:Triazines; D014665:Vasodilator Agents; D000069058:Vardenafil Dihydrochloride