TY - JOUR
T1 - Improving the sexual quality of life of couples affected by erectile dysfunction
T2 - A double-blind, randomized, placebo-controlled trial of vardenafil
AU - Fisher, William A.
AU - Rosen, Raymond C.
AU - Mollen, Martin
AU - Brock, Gerald
AU - Karlin, Gary
AU - Pommerville, Peter
AU - Goldstein, Irwin
AU - Bangerter, Keith
AU - Bandel, Tiemo Joerg
AU - Derogatis, Leonard R.
AU - Sand, Michael
PY - 2005/9
Y1 - 2005/9
N2 - Introduction. 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. Aim. 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 (≥18 years) with ED of ≥6 months duration, and their female partners. Main Outcome Measures. 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.
AB - Introduction. 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. Aim. 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 (≥18 years) with ED of ≥6 months duration, and their female partners. Main Outcome Measures. 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.
KW - Couple Sexual Function
KW - Female Sexual Function
KW - Male Erectile Dysfunction
KW - PDE5 Inhibitor
KW - Vardenafil
UR - http://www.scopus.com/inward/record.url?scp=28444489736&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=28444489736&partnerID=8YFLogxK
U2 - 10.1111/j.1743-6109.2005.00119.x
DO - 10.1111/j.1743-6109.2005.00119.x
M3 - Article
C2 - 16422828
AN - SCOPUS:28444489736
SN - 1743-6095
VL - 2
SP - 699
EP - 708
JO - Journal of Sexual Medicine
JF - Journal of Sexual Medicine
IS - 5
ER -