在勃起功能障碍的每周方案中增加每月维持低强度冲击波治疗的有效性：多中心开放标签随机研究

摘要(中文译文)

冲击波疗法被用作勃起功能障碍药物治疗的辅助手段；然而，还没有建立标准化的应用协议。评估在为期6周的方案中增加5个月的维持性冲击波治疗期治疗勃起功能障碍的有效性。共有186名未接受药物治疗的器质性勃起功能障碍男性参加了一项多中心开放标签随机临床试验。参与者被分配接受每周6次冲击波治疗或相同的方案加上每月5次额外的维持冲击波治疗。国际勃起功能指数勃起功能域（IIEF-EF）评分、最小临床重要差异（MCID）、勃起硬度评分、使用自尊和关系问卷评估的自尊，以及在治疗结束和随访12周和24周时评估的不良事件发生率。每个研究组分配了93名男性。治疗结束时，维持方案组IIEF-EF评分中位数为21.5（四分位数间距[IQR]11），随访12周时为23（IQR 12），随访24周时为22（IQR 10）。两组之间的比较没有发现统计学上的显著差异。总体而言，每周方案组35.8%的患者和维持方案组62.8%的患者在24周随访时达到了MCID（P值调整后 = .02). 两组在勃起硬度或自尊结果方面没有显著差异。两组均未报告严重不良事件。每周6次冲击波治疗加上每月5次维护治疗的方案可能对勃起功能障碍的男性有用，增加了临床改善的可能性。优势包括样本量、纳入不同程度勃起功能障碍严重程度的男性以及随机临床试验设计。局限性包括缺乏使用阴茎多普勒超声进行血管评估。与没有维持期的相同方案相比，每周6次冲击波治疗加上每月5次维持期的方案用于治疗器质性勃起功能障碍，在治疗6个月后，IIEF评分不会产生统计学上的显著变化，但可能会增加实现临床改善的概率，而不会出现严重不良事件。

Abstract

Shockwave therapy is used as an adjunct to pharmacological treatment in erectile dysfunction; however, no standardized application protocol has yet been established. To evaluate the effectiveness of adding 5 monthly maintenance shockwave therapy sessions to a 6-weekly-session protocol for the treatment of erectile dysfunction. A total of 186 men with organic erectile dysfunction, not receiving pharmacological treatment, participated in a multicenter open-label randomized clinical trial. Participants were allocated to receive either 6 weekly sessions of shockwave therapy or the same protocol plus 5 additional monthly maintenance shockwave therapy sessions. International Index of Erectile Function-Erectile Function domain (IIEF-EF) score, minimal clinically important difference (MCID), Erection Hardness Score, Self-esteem assessed using the Self-Esteem and Relationship Questionnaire, and the incidence of adverse events, assessed at the end of treatment and at 12 and 24 weeks of follow-up. Ninety-three men were allocated to each study group. Median IIEF-EF score at the end of treatment was 21.5 (interquartile range [IQR] 11), at 12 weeks of follow-up was 23 (IQR 12), and at 24 weeks of follow-up was 22 (IQR 10) in the maintenance protocol group, and 20 (IQR 11) at the end of treatment, 20 (IQR 10) at 12 weeks of follow-up, and 18 (IQR 13) at 24 weeks of follow-up in the weekly protocol. No statistically significant differences were found in these comparisons between the groups. In total, 35.8% of patients in the weekly protocol group and 62.8% in the maintenance protocol group achieved the MCID at 24 weeks of follow-up (P-value adjusted = .02). No significant differences were observed between groups in erection hardness or self-esteem outcomes. No serious adverse events were reported in either group. A protocol of 6 weekly shockwave sessions plus 5 monthly maintenance sessions may be useful in men with erectile dysfunction, increasing the likelihood of achieving clinical improvement. Strengths include the sample size, inclusion of men with varying degrees of erectile dysfunction severity, and the randomized clinical trial design. Limitations include the lack of vascular assessment using penile Doppler ultrasound. The application of a protocol of 6 weekly shockwave therapy sessions plus 5 monthly maintenance sessions, for the treatment of organic erectile dysfunction, does not generate statistically significant changes in the IIEF score up to 6 months of treatment compared to the same protocol without maintenance sessions, but may increase the probability of achieving clinical improvement, without serious adverse events.

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