Objective: We evaluated the efficacy and safety of a new low-intensity extracorporeal shockwave therapy generator, the Morenova system (Direx Systems GmbH, Wiesbaden, Germany), that offers fewer treatments and shorter treatment times through dual-probe energy delivery for patients with erectile dysfunction (ED). We additionally examined whether aging affects treatment efficacy and whether there are independent factors that predict treatment efficacy. To evaluate efficacy from the viewpoint of patient satisfaction, free comments written by the patients were analyzed by artificial intelligence (AI) to clarify the percentage of responses judged to be "positive."

Methods: This study included 64 male patients (56.5 ± 1.5 years) with ED who had undergone treatment with the Morenova. The treatment involves delivering a total of 1,800 shock waves (900 from each of the two applicators) with an energy density of 1.8 mJ/mm² to the sides of the penis and the perineum. Each patient underwent five sessions conducted two to three times per week. Efficacy was evaluated by two specific questionnaires (Sexual Health Inventory for Men, SHIM, and Erection Hardness Score), and adverse events were confirmed by direct questioning of the patients. The degree of improvement was evaluated for five age groups of patients categorized in their 30s, 40s, 50s, 60s, and 70s and older. The patients' free-form feedback on their impressions and opinions of the treatment was also evaluated by AI.

Results: We found significant improvement between pretreatment and one-month posttreatment score of the SHIM (from 11.5 ± 0.5 to 16.6 ± 0.7; p < 0.01) and Erection Hardness Score (from 1.94 ± 0.09 to 2.83 ± 0.10; p < 0.01), respectively. Significant improvement between pretreatment and three-month posttreatment scores from the two questionnaires was also found (from 11.5 ± 0.5 to 16.6 ± 0.7; p < 0.01 and from 1.94 ± 0.09 to 2.66 ± 0.13; p < 0.01, respectively). Morenova treatment caused no adverse events. The degree of improvement was not affected by the patients' age. Only pretreatment Erection Hardness Score was found to be an independent influencing factor for the efficacy of the treatment. Analysis by AI of patients' free-form feedback showed that 70% of the opinions were positive.

Conclusions: We concluded that treatment with the Morenova system is an effective and safe option for ED, which should be tried in all age groups, as approximately 70% of patients reported satisfaction with the treatment. The patients appeared to be satisfied with treatment by Morenova because of fewer clinic visits and shorter treatment times, coupled with a good response.

Keywords: erectile dysfunction; erection hardness score; satisfaction; sexual health inventory for men; shockwave treatment.

Copyright © 2025, Kato et al.

目标： 我们评估了一种新的低强度体外冲击波治疗设备——Morenova系统（Direx Systems GmbH，德国威斯巴登）的有效性和安全性。该系统通过双探头能量传递为患有勃起功能障碍（ED）的患者提供更少的治疗次数和较短的治疗时间。我们还研究了年龄是否影响疗效以及是否有独立的因素可以预测治疗效果。为了从患者的满意度角度评估有效性，利用人工智能（AI）分析了患者自由评论中“积极”反馈的比例。

方法： 本研究包括64名男性ED患者（平均56.5 ± 1.5岁），他们接受了Morenova系统的治疗。该治疗方法涉及向阴茎两侧和会阴部输送总计1800次冲击波（每个探头900次，能量密度为1.8 mJ/mm²）。每位患者进行了五次疗程，每周进行两到三次。疗效通过两个特定问卷（男性性健康调查表SHIM和勃起硬度评分）评估，并直接询问患者是否有不良事件发生。根据患者的年龄将受试者分为五个年龄段（30岁、40岁、50岁、60岁及70岁以上及以上），并评估了改善程度。此外，还通过AI对患者关于治疗印象和意见的自由形式反馈进行了评价。

结果： 在SHIM评分（从11.5 ± 0.5到16.6 ± 0.7；p

结论： 我们得出结论，Morenova系统的治疗对于ED来说是一种有效且安全的选择，可以在所有年龄段试用，因为大约70%的患者对治疗表示满意。由于就诊次数较少、治疗时间较短以及较好的反应效果，患者似乎对该治疗方法感到满意。

关键词： 勃起功能障碍；勃起硬度评分；满意度；男性性健康调查表；冲击波治疗。