Department of Urology, University of Miami, Miami, FL, USA.
Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Int J Impot Res. 2019 May;31(3):206-208. doi: 10.1038/s41443-019-0115-1. Epub 2019 Jan 22.
Our interim analysis of a phase II clinical trial on low-intensity extracorporeal shockwave therapy (Li-ESWT) for men with erectile dysfunction (ED) has demonstrated it is safe with no reported adverse outcomes. Interim analysis has demonstrated Sexual Encounter Profile 3 (ability to maintain erection till completion) was achieved in 60% of men prior to Li-ESWT, which increased to 90% after treatment. Nevertheless, limitations of our clinical trial include the lack of a sham arm and our inability to exclude men with psychogenic ED. We have begun recruitment of our phase III clinical trial that will allow assessment of treatment efficacy against a sham control arm. There exists substantial interest in the use of restorative therapies (i.e., Li-ESWT, stem cells, and platelet rich plasma) for men with ED with the potential to combine therapies to potentially lead to an augmented response.
我们对低强度体外冲击波疗法（Li-ESWT）治疗勃起功能障碍（ED）男性的 II 期临床试验的中期分析表明，该疗法安全，无不良事件报告。中期分析表明，在 Li-ESWT 治疗前，60%的男性能够达到性接触剖面图 3（维持勃起直到完成的能力），而治疗后这一比例增加到 90%。然而，我们的临床试验存在局限性，包括缺乏假手术组和我们无法排除心理性 ED 男性。我们已经开始招募我们的 III 期临床试验，这将允许评估治疗效果对假手术对照组。对于 ED 男性，使用恢复性治疗（即 Li-ESWT、干细胞和富含血小板的血浆）存在很大的兴趣，有可能将多种治疗方法结合起来，从而有可能产生增强的反应。
