Neuro-Urology Unit, Rambam Healthcare Campus, and the Rappaport Faculty of Medicine, Technion - IIT, Haifa, Israel.
J Urol. 2012 May;187(5):1769-75. doi: 10.1016/j.juro.2011.12.117. Epub 2012 Mar 15.
We investigated the clinical and physiological effect of low intensity extracorporeal shock wave therapy on men with organic erectile dysfunction who are phosphodiesterase type 5 inhibitor responders.
After a 1-month phosphodiesterase type 5 inhibitor washout period, 67 men were randomized in a 2:1 ratio to receive 12 sessions of low intensity extracorporeal shock wave therapy or sham therapy. Erectile function and penile hemodynamics were assessed before the first treatment (visit 1) and 1 month after the final treatment (followup 1) using validated sexual function questionnaires and venoocclusive strain gauge plethysmography.
Clinically we found a significantly greater increase in the International Index of Erectile Function-Erectile Function domain score from visit 1 to followup 1 in the treated group than in the sham treated group (mean ± SEM 6.7 ± 0.9 vs 3.0 ± 1.4, p = 0.0322). There were 19 men in the treated group who were initially unable to achieve erections hard enough for penetration (Erection Hardness Score 2 or less) who were able to achieve erections sufficiently firm for penetration (Erection Hardness Score 3 or greater) after low intensity extracorporeal shock wave therapy, compared to none in the sham group. Physiologically penile hemodynamics significantly improved in the treated group but not in the sham group (maximal post-ischemic penile blood flow 8.2 vs 0.1 ml per minute per dl, p <0.0001). None of the men experienced discomfort or reported any adverse effects from the treatment.
This is the first randomized, double-blind, sham controlled study to our knowledge that shows that low intensity extracorporeal shock wave therapy has a positive short-term clinical and physiological effect on the erectile function of men who respond to oral phosphodiesterase type 5 inhibitor therapy. The feasibility and tolerability of this treatment, coupled with its potential rehabilitative characteristics, make it an attractive new therapeutic option for men with erectile dysfunction.
我们研究了低强度体外冲击波治疗对磷酸二酯酶 5 抑制剂反应阳性的器质性勃起功能障碍男性的临床和生理影响。
在经历 1 个月的磷酸二酯酶 5 抑制剂洗脱期后，67 名男性按 2:1 的比例随机分为低强度体外冲击波治疗组或假治疗组，每组接受 12 次治疗。使用经过验证的性功能问卷和静脉闭塞应变计体积描记法，在第一次治疗前（第 1 次就诊）和最后一次治疗后 1 个月（第 1 次随访）评估勃起功能和阴茎血流动力学。
临床方面，与假治疗组相比，治疗组的国际勃起功能指数-勃起功能域评分从第 1 次就诊到第 1 次随访显著增加（平均 ± SEM 6.7 ± 0.9 比 3.0 ± 1.4，p = 0.0322）。在治疗组中，有 19 名最初无法达到足以进行插入的勃起硬度评分（勃起硬度评分 2 或更低）的男性在接受低强度体外冲击波治疗后能够达到足以进行插入的勃起硬度评分（勃起硬度评分 3 或更高），而假治疗组中没有男性达到。在治疗组中，阴茎血流动力学显著改善，但在假治疗组中没有改善（最大缺血后阴茎血流 8.2 比 0.1 毫升/分钟/每 dl，p <0.0001）。没有男性出现不适或报告任何治疗相关的不良反应。
这是我们所知的首次随机、双盲、假对照研究，表明低强度体外冲击波治疗对口服磷酸二酯酶 5 抑制剂治疗反应阳性的男性勃起功能具有短期的临床和生理影响。这种治疗的可行性和耐受性，加上其潜在的康复特性，使其成为勃起功能障碍男性的一种有吸引力的新治疗选择。
