Emmett H Kennady, Darren J Bryk, Marwan M Ali, Sarah J Ratcliffe, Indika V Mallawaarachchi, Bahrom J Ostad, Hamza M Beano, Christopher C Ballantyne, Sarah C Krzastek, Matthew B Clements, Mikel L Gray, David E Rapp, Nicolas M Ortiz, Ryan P Smith
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The sham group was allowed to cross over to receive shockwave therapy after 1 month.</p><p><strong>Outcomes: </strong>Primary outcomes were the changes in Sexual Health Inventory for Men (SHIM) score and Erection Hardness Score at 1 month following shockwave therapy vs sham, and secondary outcomes were erectile function measurements at 1, 3, and 6 months following shockwave therapy.</p><p><strong>Results: </strong>At 1 month, mean SHIM scores were significantly increased in the shockwave therapy arm as compared with the sham arm (+3.0 vs -0.7, <i>P</i> = .024). Participants at 6 months posttreatment (n = 33) showed a mean increase of 5.5 points vs baseline (<i>P</i> < .001), with 20 (54.6%) having an increase ≥5. Of the 25 men with an initial Erection Hardness Score <3, 68% improved to a score ≥3 at 6 months. 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引用次数: 0
摘要
背景:低强度冲击波治疗勃起功能障碍正成为一种有前景的治疗选择。目的:本随机假对照交叉试验评估低强度冲击波治疗勃起功能障碍的疗效。方法:33名有器质性勃起功能障碍的参与者被纳入研究，随机分为冲击波治疗组(n = 17)和假手术组(n = 16)。假手术组在1个月后交叉接受冲击波治疗。结果:主要结果是冲击波治疗后1个月男性性健康量表(SHIM)评分和勃起硬度评分的变化，次要结果是冲击波治疗后1、3和6个月的勃起功能测量。结果:在1个月时，冲击波治疗组的平均SHIM评分明显高于假手术组(+3.0 vs -0.7, P = 0.024)。临床意义:在这个随机的假对照交叉试验中，我们发现54.6%的器质性勃起功能障碍患者在接受低强度冲击波治疗后，SHIM评分达到了最小的临床重要差异。优势和局限性:本研究的优势包括一个假性控制组。局限性包括单个机构的样本量不大。结论:与假治疗相比，低强度冲击波治疗可改善勃起功能障碍男性的勃起功能，甚至在治疗后6个月仍能持续。临床试验注册:ClinicalTrials.gov NCT04434352。
Background: Low-intensity shockwave therapy for erectile dysfunction is emerging as a promising treatment option.
Aim: This randomized sham-controlled crossover trial assessed the efficacy of low-intensity shockwave therapy in the treatment of erectile dysfunction.
Methods: Thirty-three participants with organic erectile dysfunction were enrolled and randomized to shockwave therapy (n = 17) or sham (n = 16). The sham group was allowed to cross over to receive shockwave therapy after 1 month.
Outcomes: Primary outcomes were the changes in Sexual Health Inventory for Men (SHIM) score and Erection Hardness Score at 1 month following shockwave therapy vs sham, and secondary outcomes were erectile function measurements at 1, 3, and 6 months following shockwave therapy.
Results: At 1 month, mean SHIM scores were significantly increased in the shockwave therapy arm as compared with the sham arm (+3.0 vs -0.7, P = .024). Participants at 6 months posttreatment (n = 33) showed a mean increase of 5.5 points vs baseline (P < .001), with 20 (54.6%) having an increase ≥5. Of the 25 men with an initial Erection Hardness Score <3, 68% improved to a score ≥3 at 6 months. When compared with baseline, the entire cohort demonstrated significant increases in erectile function outcomes at 1, 3, and 6 months after treatment.
Clinical implications: In this randomized sham-controlled crossover trial, we showed that 54.6% of participants with organic erectile dysfunction met the minimal clinically important difference in SHIM scores after treatment with low-intensity shockwave therapy.
Strengths and limitations: Strengths of this study include a sham-controlled group that crossed over to treatment. Limitations include a modest sample size at a single institution.
Conclusions: Low-intensity shockwave therapy improves erectile function in men with erectile dysfunction as compared with sham treatment, which persists even 6 months after treatment.
期刊介绍：
Sexual Medicine is an official publication of the International Society for Sexual Medicine, and serves the field as the peer-reviewed, open access journal for rapid dissemination of multidisciplinary clinical and basic research in all areas of global sexual medicine, and particularly acts as a venue for topics of regional or sub-specialty interest. The journal is focused on issues in clinical medicine and epidemiology but also publishes basic science papers with particular relevance to specific populations. Sexual Medicine offers clinicians and researchers a rapid route to publication and the opportunity to publish in a broadly distributed and highly visible global forum. The journal publishes high quality articles from all over the world and actively seeks submissions from countries with expanding sexual medicine communities. Sexual Medicine relies on the same expert panel of editors and reviewers as The Journal of Sexual Medicine and Sexual Medicine Reviews.
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