Department of Urology, Hospital Carlos Haya, Malaga, Spain.
J Sex Med. 2011 Oct;8(10):2831-40. doi: 10.1111/j.1743-6109.2011.02352.x. Epub 2011 Jun 16.
Erectile dysfunction (ED) impacts on both members of the couple. Female partners of men with ED are more likely to report reduced sexual quality of life than women whose partners do not have ED.
To assess vardenafil efficacy in men with ED and determine the effects of treatment on their female partner's sexual quality of life.
Study participants comprised men aged 18-64 years with ED and their female partners. Eligible men had ED of ≥6 months' duration and a female partner who was motivated to support their ED treatment. Eligible women had a total Female Sexual Function Index score >23.55, indicating absence of significant sexual dysfunction. Following a 4-week screening period, men were randomized to treatment with vardenafil 10 mg or placebo, which could be titrated to 20 or 5 mg after 4 weeks.
Primary efficacy variables were question 3 of the Sexual Encounter Profile questionnaire (SEP3) and the quality-of-life domain of the modified Sexual Life Quality Questionnaire (mSLQQ-QOL).
The intent-to-treat population included 343 couples, with 168 and 175 men receiving vardenafil or placebo, respectively. Vardenafil treatment significantly improved both erection maintenance and the female partners' sexual quality of life. Least squares (LS) mean SEP3 overall success rates after 12 weeks of treatment were 9.5 (baseline) vs. 67.2 (week 12) and 12.4 (baseline) vs. 24.2 (week 12) in the vardenafil and placebo groups, respectively (P < 0.0001). In female partners, LS mean mSLQQ-QOL scores were 28.8 (baseline) vs. 68.2 (last observation carried forward [LOCF]) in the vardenafil group and 24.6 (baseline) vs. 40.5 (LOCF) in the placebo group (P < 0.0001).
Vardenafil treatment of men with ED improved both their erectile function and the sexual quality of life of their female partners.
勃起功能障碍（ED）会影响夫妻双方。与没有 ED 的伴侣相比，ED 男性的女性伴侣更有可能报告性生活质量下降。
评估伐地那非治疗 ED 男性的疗效，并确定治疗对其女性伴侣性生活质量的影响。
研究对象包括年龄在 18-64 岁之间的 ED 男性及其女性伴侣。符合条件的男性 ED 持续时间≥6 个月，且女性伴侣有动力支持 ED 治疗。符合条件的女性的总女性性功能指数评分>23.55，表明不存在明显的性功能障碍。经过 4 周的筛选期后，男性随机接受伐地那非 10mg 或安慰剂治疗，4 周后可滴定至 20mg 或 5mg。
主要疗效变量是性遭遇剖面图问卷（SEP3）的问题 3 和改良性生活质量问卷（mSLQQ-QOL）的生活质量域。
意向治疗人群包括 343 对夫妇，分别有 168 名和 175 名男性接受伐地那非或安慰剂治疗。伐地那非治疗显著改善了勃起维持和女性伴侣的性生活质量。治疗 12 周后的最小二乘（LS）均值 SEP3 总体成功率分别为 9.5（基线）与 67.2（第 12 周）和 12.4（基线）与 24.2（第 12 周），分别在伐地那非和安慰剂组（P<0.0001）。在女性伴侣中，LS 均值 mSLQQ-QOL 评分分别为 28.8（基线）与 68.2（最后观察值延续[LOCF]）在伐地那非组和 24.6（基线）与 40.5（LOCF）在安慰剂组（P<0.0001）。
治疗 ED 男性的伐地那非治疗不仅改善了他们的勃起功能，还改善了他们女性伴侣的性生活质量。
