Neuro-urology Unit, Rambam Healthcare Campus, Haifa, Israel.
J Sex Med. 2012 Jan;9(1):259-64. doi: 10.1111/j.1743-6109.2011.02498.x. Epub 2011 Oct 18.
Low-intensity shock wave therapy (LI-ESWT) has been reported as an effective treatment in men with mild and moderate erectile dysfunction (ED).
The aim of this study is to determine the efficacy of LI-ESWT in severe ED patients who were poor responders to phosphodiesterase type 5 inhibitor (PDE5i) therapy.
This was an open-label single-arm prospective study on ED patients with an erection hardness score (EHS) ≤ 2 at baseline. The protocol comprised two treatment sessions per week for 3 weeks, which were repeated after a 3-week no-treatment interval. Patients were followed at 1 month (FU1), and only then an active PDE5i medication was provided for an additional month until final follow-up visit (FU2). At each treatment session, LI-ESWT was applied on the penile shaft and crus at five different anatomical sites (300 shocks, 0.09 mJ/mm(2) intensity at 120 shocks/min). Each subject underwent a full baseline assessment of erectile function using validated questionnaires and objective penile hemodynamic testing before and after LI-ESWT.
Outcome measures used are changes in the International Index of Erectile Function-erectile function domain (IIEF-ED) scores, the EHS measurement, and the three parameters of penile hemodynamics and endothelial function.
Twenty-nine men (mean age of 61.3) completed the study. Their mean IIEF-ED scores increased from 8.8 ± 1 (baseline) to 12.3 ± 1 at FU1 (P = 0.035). At FU2 (on active PDE5i treatment), their IIEF-ED further increased to 18.8 ± 1 (P < 0.0001), and 72.4% (P < 0.0001) reached an EHS of ≥ 3 (allowing full sexual intercourse). A significant improvement (P = 0.0001) in penile hemodynamics was detected after treatment and this improvement significantly correlated with increases in the IIEF-ED (P < 0.05). No noteworthy adverse events were reported.
Penile LI-ESWT is a new modality that has the potential to treat a subgroup of severe ED patients. These preliminary data need to be reconfirmed by multicenter sham control studies in a larger group of ED patients.
低强度冲击波疗法（LI-ESWT）已被报道为治疗轻度和中度勃起功能障碍（ED）的有效方法。
本研究旨在确定 LI-ESWT 对磷酸二酯酶 5 抑制剂（PDE5i）治疗反应不佳的严重 ED 患者的疗效。
这是一项对基线勃起硬度评分（EHS）≤2 的 ED 患者进行的开放性单臂前瞻性研究。方案包括每周两次治疗，共 3 周，然后在 3 周无治疗间隔后重复。患者在 1 个月（FU1）时进行随访，此时仅提供有效的 PDE5i 药物治疗，直至最终随访（FU2）。在每次治疗中，LI-ESWT 应用于阴茎干和阴茎脚的五个不同解剖部位（300 次冲击，0.09 mJ/mm2 强度，120 次冲击/分钟）。每个患者在 LI-ESWT 前后都接受了勃起功能的完整基线评估，使用经过验证的问卷和客观的阴茎血流动力学测试。
使用的观察指标是国际勃起功能指数-勃起功能域（IIEF-ED）评分、EHS 测量以及阴茎血流动力学和内皮功能的三个参数的变化。
29 名男性（平均年龄 61.3 岁）完成了研究。他们的平均 IIEF-ED 评分从基线时的 8.8±1 增加到 FU1 时的 12.3±1（P=0.035）。在 FU2（接受有效 PDE5i 治疗时），IIEF-ED 进一步增加至 18.8±1（P<0.0001），72.4%（P<0.0001）达到 EHS≥3（允许完全性交）。治疗后检测到阴茎血流动力学显著改善（P=0.0001），并且这种改善与 IIEF-ED 的增加显著相关（P<0.05）。没有报告明显的不良事件。
阴茎 LI-ESWT 是一种有潜力治疗严重 ED 患者亚群的新方法。这些初步数据需要在更大的 ED 患者群体中通过多中心假对照研究来进一步证实。
