Patel Premal, Katz Jonathan, Lokeshwar Soum D, Molina Manuel, Reis Isildinha M, Clavijo Raul, Ramasamy Ranjith
Section of Urology, University of Manitoba, Winnipeg, Manitoba, Canada.
Department of Urology, University of Miami, Miller School of Medicine, Miami, FL, USA.
Sex Med. 2020 Jun;8(2):214-222. doi: 10.1016/j.esxm.2020.01.010. Epub 2020 Mar 14.
To evaluate safety and clinical response of Low-intensity Shockwave Therapy (Li-SWT) for the treatment of erectile dysfunction.
MATERIALS & METHODS: A single-institution, 2 arm, phase II randomized clinical trial was conducted between February 2017 and April 2019. Patients were randomized into 2 groups, with Li-SWT delivering a total of 3,600 shocks over 5 days (720 once a day, Group A) or over 2 weeks (600 once a day, 3 times a week, Group B). Patients were evaluated for the safety of therapy and completed the International Index of Erectile Function-Erectile Function domain and the Erectile Hardness Scale assessment at baseline, and at 1, 3, and 6 months visits.
Among 87 evaluable patients, 45 and 42 were allocated to Groups A and B treatment schedules, respectively, and 80 patients (40 per group) completed the 6-month evaluation. No adverse events were reported during treatment or during follow-up. There were statistically significant (P < .05) improvements in International Index of Erectile Function-Erectile Function score (mean increase of 2.7 [95% CI = 1.2, 4.2] and 2.7 points [95% CI = 1.4, 4.1] for Groups A and B, respectively) and in Erectile Hardness Scale (mean increase of 0.6 points (95% CI = 0.3, 0.8) and 0.5 (95% CI = 0.2, 0.8) for Groups A and B, respectively) at 6 months, with no differences between groups.
No difference in outcomes was found when Li-SWT 3,600 shocks were delivered over 1 or 2 weeks at 6 months follow-up and both schedules were safe with no adverse events during or after treatment. Further trials with longer follow-up and sham arm will provide valuable information regarding treatment efficacy and durability. Patel P, Katz J, Lokeshwar SD, et al. Phase II Randomized, Clinical Trial Evaluating 2 Schedules of Low-Intensity Shockwave Therapy for the Treatment of Erectile Dysfunction. Sex Med 2020;8:214-222.
评估低强度冲击波疗法（Li-SWT）治疗勃起功能障碍的安全性和临床反应。
2017年2月至2019年4月在单一机构进行了一项双臂II期随机临床试验。患者被随机分为两组，Li-SWT组在5天内共进行3600次冲击（每天一次，每次720次，A组）或在2周内进行（每周3次，每次600次，B组）。评估患者治疗的安全性，并在基线时以及在第1、3和6个月就诊时完成国际勃起功能指数-勃起功能领域和勃起硬度量表评估。
在87例可评估患者中，分别有45例和42例被分配到A组和B组治疗方案，80例患者（每组40例）完成了6个月的评估。治疗期间或随访期间均未报告不良事件。在6个月时，国际勃起功能指数-勃起功能评分（A组平均增加2.7分[95%CI = 1.2, 4.2]，B组平均增加2.7分[95%CI = 1.4, 4.1]）和勃起硬度量表（A组平均增加0.6分[95%CI = 0.3, 0.8]，B组平均增加0.5分[95%CI = 0.2, 0.8]）有统计学显著改善（P < 0.05），两组之间无差异。
在6个月随访时，3600次冲击的Li-SWT在1周或2周内进行，结果无差异，且两种方案均安全，治疗期间或之后均无不良事件。进一步进行更长随访期和设假手术组的试验将提供有关治疗效果和持久性的有价值信息。帕特尔P、卡茨J、洛凯什瓦尔SD等。评估低强度冲击波疗法治疗勃起功能障碍的两种方案的II期随机临床试验。性医学2020；8：214 - 222。
