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Low-intensity shockwave therapy (LiST) for erectile dysfunction: a randomized clinical trial assessing the impact of energy flux density (EFD) and frequency of sessions.
International Journal of Impotence Research ( IF 2.6 ) Pub Date : 2019-09-02 , DOI: 10.1038/s41443-019-0185-0
Dimitrios Kalyvianakis 1, 2 , Ioannis Mykoniatis 1, 2 , Evangelos Memmos 1 , Paraskevi Kapoteli 1 , Dimitrios Memmos 1 , Dimitrios Hatzichristou 1, 2
Affiliation  

The impact of energy flux density (EFD) used on low-intensity shockwave therapy (LiST) for erectile dysfunction (ED) has not been explored. Our aim was to compare EFD 0.05 versus 0.10 mJ/mm2 regarding efficacy and safety of 12-treatment sessions when applied two or three times per week. Ninety-seven patients with vasculogenic ED, PDE5 inhibitors users were randomized into four groups, to receive 12 LiST sessions. Group A (n = 24) : two sessions per week, EFD 0.05 mJ/mm2; Group B (n = 24): three sessions per week, EFD 0.05 mJ/mm2; Group C (n = 24): two sessions per week, EFD 0.10 mJ/mm2; Group D (n = 25): three sessions per week, EFD 0.10 mJ/mm2. International Index for Erectile Function-Erectile Function domain (IIEF-EF), Minimally clinical important differences (MCID), sexual encounter profile, and triplex ultrasonography parameters were used to asses erectile function. Eighty-nine patients completed the 6-month follow-up (FU). All four groups improved in mean IIEF-EF score, average SEP3 "Yes" response rates at 6-month FU visit compared with baseline (p < 0.001). MCID at 6-month FU visit was achieved in 82.6%, 77.3%, 87%, and 81% in Groups A, B, C, and D, respectively. Mean PSV (cm/s) at baseline versus 3-month FU visit were 30.32 versus 34.67 for Group A, 30.02 versus 35.02 for Group B, 30.2 versus 36.02, for Group C, 29.43 versus 34.3 for Group D (p < 0.01). There were no statistical significant differences in the change of all outcome measures assessing erectile function between different sessions frequency. A tendency for better efficacy using EFD 0.10 mJ/mm2 was noticed, although it did not reach statistical significance. No treatment-related side-effects were reported. This study lacks a sham-controlled arm. However, all patients were randomized to the four groups, and baseline characteristics were similar between the groups. Moreover, arterial insufficiency was confirmed among all patients by penile triplex ultrasonography. Conclusively, patients may benefit equally when sessions are applied either two or three per week. An EFD of 0.10 mJ/mm2 could result in better outcomes, but further studies are needed to validate this observation.

中文翻译:

低强度冲击波治疗勃起功能障碍:一项随机临床试验,评估能量通量密度(EFD)和疗程频率的影响。

尚未探讨能量通量密度(EFD)对勃起功能障碍(ED)的低强度冲击波治疗(LiST)的影响。我们的目的是比较每周两次或三次使用12次治疗的疗效和安全性,将EFD 0.05与0.10 mJ / mm2进行比较。接受血管生成性ED,PDE5抑制剂治疗的97例患者被随机分为四组,接受12次LiST疗程。A组(n = 24):每周两次,EFD 0.05 mJ / mm2;B组(n = 24):每周三节,EFD 0.05 mJ / mm2;C组(n = 24):每周两次,EFD 0.10 mJ / mm2;D组(n = 25):每周三节,EFD 0.10 mJ / mm2。勃起功能国际指数-勃起功能域(IIEF-EF),最低限度的临床重要差异(MCID),性经历概况,使用三重超声参数评估勃起功能。89名患者完成了6个月的随访(FU)。与基线相比,所有四个组在6个月FU访视时的IIEF-EF平均得分,SEP3平均平均“是”缓解率均得到改善(p <0.001)。A,B,C和D组在6个月FU访视时的MCID分别达到82.6%,77.3%,87%和81%。基线vs 3个月FU访视时的平均PSV(cm / s)对于A组为30.32对34.67,对于B组为30.02对35.02,对于B组为30.2对36.02,对于D组为29.43对34.3(p <0.01)。在评估不同勃起功能的勃起功能的所有结局指标的变化之间,差异无统计学意义。注意到使用EFD 0.10 mJ / mm2有更好的疗效趋势,尽管它没有达到统计学意义。没有报道与治疗有关的副作用。这项研究缺乏假手术控制的手臂。但是,所有患者均被随机分为四组,两组之间的基线特征相似。此外,阴茎三联超声检查在所有患者中均证实了动脉供血不足。最终,每周两次或三个疗程可以使患者平等受益。EFD为0.10 mJ / mm2可能会产生更好的结果,但是需要进一步的研究来验证这一观察结果。阴茎三联超声检查在所有患者中均证实了动脉供血不足。最终,每周两次或三个疗程可以使患者平等受益。EFD为0.10 mJ / mm2可能会产生更好的结果,但是需要进一步的研究来验证这一观察结果。阴茎三联超声检查在所有患者中均证实了动脉供血不足。最终,每周两次或三个疗程可以使患者平等受益。EFD为0.10 mJ / mm2可能会产生更好的结果,但是需要进一步的研究来验证这一观察结果。
更新日期:2019-09-03
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