Althof Stanley E, O'Leary Michael P, Cappelleri Joseph C, Crowley Arthur R, Tseng Li-Jung, Collins Suzanne
Center for Marital and Sexual Health of South Florida, West Palm Beach, Florida 33401, USA.
J Urol. 2006 Nov;176(5):2132-7. doi: 10.1016/j.juro.2006.07.019.
The first double-blind, placebo controlled trial in the United States of the Self-Esteem And Relationship questionnaire revealed that treatment with sildenafil citrate improves erectile function and measures of quality of life in men with erectile dysfunction. We investigated long-term improvement, and correlations between improved erectile function and confidence, self-esteem and sexual relationship satisfaction in men with erectile dysfunction.
This was a 36-week open label extension of the double-blind, placebo controlled trial. The blind was not broken. Patients were 18 years or older with clinically diagnosed erectile dysfunction. Erectile function was assessed using the International Index of Erectile Function. Self-esteem, confidence and relationship satisfaction were assessed using the Self-Esteem And Relationship questionnaire. Correlations were determined using Pearson's product moment coefficients.
A total of 204 participants were enrolled in the open label extension, including 108 on placebo and 96 on sildenafil. In men who received placebo in the double-blind, placebo controlled phase mean erectile function scores and self-esteem, confidence and relationship satisfaction scores were increased significantly at week 36 of the open label extension (p < 0.0001). Men who received sildenafil in the double-blind, placebo controlled phase maintained high scores in the open label extension. Correlations between improved erectile function, and self-esteem, confidence and relationship satisfaction were strong and positive (p < 0.0001).
Open label extension sildenafil after double-blind, placebo controlled placebo significantly improved erectile function, self-esteem, confidence and relationship satisfaction. Following an initial 12 weeks of double-blind, placebo controlled sildenafil therapy for erectile dysfunction improvements were sustained an additional 9 months. Positive correlations between erectile function, and self-esteem, confidence and relationship satisfaction suggest that improved erectile quality can improve long-term psychosocial quality of life.
在美国进行的第一项关于自尊与关系问卷的双盲、安慰剂对照试验表明，枸橼酸西地那非治疗可改善勃起功能障碍男性的勃起功能及生活质量指标。我们调查了勃起功能障碍男性的长期改善情况，以及勃起功能改善与自信、自尊和性关系满意度之间的相关性。
这是一项双盲、安慰剂对照试验的36周开放标签扩展研究。未揭盲。患者年龄在18岁及以上，临床诊断为勃起功能障碍。使用国际勃起功能指数评估勃起功能。使用自尊与关系问卷评估自尊、自信和关系满意度。使用Pearson积矩系数确定相关性。
共有204名参与者纳入开放标签扩展研究，其中108名接受安慰剂，96名接受西地那非。在双盲、安慰剂对照阶段接受安慰剂的男性中，开放标签扩展研究第36周时平均勃起功能评分以及自尊、自信和关系满意度评分显著提高（p<0.0001）。在双盲、安慰剂对照阶段接受西地那非的男性在开放标签扩展研究中保持高分。勃起功能改善与自尊、自信和关系满意度之间的相关性强且呈正相关（p<0.0001）。
双盲、安慰剂对照后开放标签扩展使用西地那非可显著改善勃起功能、自尊、自信和关系满意度。在最初12周的双盲、安慰剂对照西地那非治疗勃起功能障碍后，改善持续了额外9个月。勃起功能与自尊、自信和关系满意度之间的正相关表明，勃起质量的改善可提高长期心理社会生活质量。
