首页> 外文期刊>The journal of sexual medicine >Validation of stopwatch measurements of erection duration against responses to the sexual encounter profile and international index of erectile Function in patients treated with a phosphodiesterase type 5 inhibitor.
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Validation of stopwatch measurements of erection duration against responses to the sexual encounter profile and international index of erectile Function in patients treated with a phosphodiesterase type 5 inhibitor.

机译:用5型磷酸二酯酶抑制剂治疗的患者对性交反应和勃起功能国际指数的反应的勃起持续时间的秒表测量值的验证。

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INTRODUCTION: Although the Sexual Encounter Profile (SEP) and International Index of Erectile Function (IIEF) are frequently used to measure erectile dysfunction (ED) treatment outcomes, stopwatch-assessed duration of erection is a new, objective, and potentially useful endpoint of ED treatment effect. AIMS: To assess the validity and reliability of stopwatch-assessed erection duration against responses to SEP items 2 (SEP-2) and 3 (SEP-3) and IIEF scale scores. METHODS: Data were taken from a multi-center trial of vardenafil for the treatment of ED. Patients were randomized to vardenafil 10 mg or placebo for 4 weeks. After a 1-week washout period, patients received the alternate therapy for an additional 4 weeks. An electronic diary was used to record information about sexual attempts. The duration of erection was measured using a stopwatch and transcribed into the diary. The SEP was completed following each sexual attempt, and the IIEF was completed at the end of each treatment period. MAIN OUTCOME MEASURES: Mean and median values of erection duration, mean SEP-2 and SEP-3 success rates, and scores for each of the 5 IIEF scales were calculated. RESULTS: At baseline, correlations of median erection duration with the 5 IIEF scale scores ranged from 0.06 to 0.53, while correlations with mean SEP-2 and SEP-3 success rates were 0.66 and 0.49, respectively. Compared with the other measures, mean and median values of erection duration were less sensitive to differences between placebo- and vardenafil-treated patients and less responsive to clinical change associated with treatment crossover. However, mean erection duration exhibited a good level of reliability (intraclass correlation coefficient = 0.72, P < 0.001). CONCLUSIONS: This study provides evidence for the validity and reliability of stopwatch-assessed duration of erection. Our findings suggest that erection duration is suitable for use as a unique endpoint in ED treatment-efficacy trials conducted for phosphodiesterase type 5 inhibitors.
机译:简介:尽管经常使用性接触档案(SEP)和国际勃起功能指数(IIEF)来衡量勃起功能障碍(ED)的治疗效果,但秒表评估的勃起持续时间是ED的新的,客观的且可能有用的终点治疗效果。目的:评估秒表评估的勃起持续时间相对于对SEP项目2(SEP-2)和3(SEP-3)以及IIEF量表得分的反应的有效性和可靠性。方法:数据来自伐地那非治疗ED的多中心试验。患者被随机分配接受伐地那非10 mg或安慰剂治疗4周。经过1周的冲洗期后,患者再接受替代治疗4周。电子日记被用来记录有关性尝试的信息。使用秒表测量勃起的持续时间,并记录到日记中。每次性尝试后均完成SEP,每个治疗期结束时均完成IIEF。主要观察指标:计算勃起持续时间的平均值和中位数,平均SEP-2和SEP-3成功率以及5个IIEF量表的得分。结果:在基线时,中位勃起持续时间与5个IIEF量表得分的相关性在0.06至0.53之间,而与平均SEP-2和SEP-3成功率的相关性分别为0.66和0.49。与其他措施相比,勃起持续时间的平均值和中值对安慰剂和伐地那非治疗的患者之间的差异较不敏感,对与治疗交叉相关的临床变化的反应较不敏感。但是,平均勃起持续时间表现出良好的可靠性(类内相关系数= 0.72,P <0.001)。结论:这项研究为秒表评估勃起持续时间的有效性和可靠性提供了证据。我们的发现表明,勃起持续时间适合用作针对5型磷酸二酯酶抑制剂的ED治疗功效试验的唯一终点。

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