Cui Wanshou, Li Huixi, Guan Ruili, Li Meng, Yang Bicheng, Xu Zhanwei, Lin Maofan, Tian Long, Zhang Xiaodong, Li Bao, Liu Weiguang, Dong Zhilong, Wang Zhiping, Zheng Tao, Zhang Weixing, Lin Guiting, Guo Yinglu, Xin Zhongcheng
Andrology Center, Peking University First Hospital, Beijing 100034, China.
Wanbeili Medical instrument Co., Ltd., Beijing 102200, China.
Transl Androl Urol. 2019 Aug;8(4):307-319. doi: 10.21037/tau.2019.07.03.
In our previous study, a novel low-intensity pulsed ultrasound (LIPUS) therapeutic device has been shown to improve erectile function non-invasively in a diabetic-induced erectile dysfunction (ED) animal model.
In order to investigate the efficacy and safety of LIPUS in the clinical treatment of patients with ED, a multicenter, randomized, double-blind, sham-treated, controlled clinical study was conducted at five medical centers, and 120 patients with mild to moderate ED were enrolled in the study. Patients were randomized into a sham-treated control group (40 patients) or a LIPUS-treated group (80 patients). LIPUS or sham treatment was applied to both sides of the penis shaft and crus for 5 min in each area, twice a week for four weeks. Assessment of efficacy and safety were evaluated using IIEF-5, Sexual Encounter Profile (SEP)-questionnaires 2/3, Global Assessment Question (GAQ), Erectile Hardness Score (EHS), Erection Quality Scale (EQS) score, and pain assessment [Visual Analogue Scale/Score (VAS)].
Ten patients in LIPUS treatment group and 6 patients in sham treatment control group were excluded and the dropout rate is 13.33%. Response to treatment was identified as IIEF-5 score increased more than 2/3/4 points of post-treatment (12W) compared to pre-treatment (0W). The response rate in treatment group was 54/80 (67.50%), which was significantly higher than control group 8/40 (20.00%) at 12 weeks (FAS analysis). The percentage of patients with positive answers to SEP-3 (successful vaginal intercourse) were 58.97%, 64.1%, and 73.08% 4, 8, and 12 weeks after treatment which were significantly higher than 28.95%, 31.58%, and 28.95% respectively in control group (FAS, P<0.05). The positive responsive rates for GAQ in treatment group were about 2 to 3 times of that in control group (P<0.05). No treatment-related adverse events (AEs) were found, including local petechia or ecchymosis and hematuria.
Current study indicates that LIPUS can safely and effectively treat patients with mild to moderate ED without significant AEs, which is related to the mechanical force of LIPUS and can restore the pathological changes of the corpus cavernosum. LIPUS is a promising alternative treatment for ED treatment in the near future, while further research is remanded.
在我们之前的研究中，一种新型低强度脉冲超声（LIPUS）治疗设备已被证明可在糖尿病诱导的勃起功能障碍（ED）动物模型中无创改善勃起功能。
为了研究LIPUS在ED患者临床治疗中的疗效和安全性，在五个医疗中心进行了一项多中心、随机、双盲、假治疗对照的临床研究，120例轻度至中度ED患者纳入研究。患者被随机分为假治疗对照组（40例患者）或LIPUS治疗组（80例患者）。LIPUS或假治疗应用于阴茎体和阴茎脚两侧，每个区域5分钟，每周两次，共四周。使用国际勃起功能指数-5（IIEF-5）、性接触概况（SEP）问卷2/3、总体评估问题（GAQ）、勃起硬度评分（EHS）、勃起质量量表（EQS）评分以及疼痛评估[视觉模拟量表/评分（VAS）]评估疗效和安全性。
LIPUS治疗组有10例患者和假治疗对照组有6例患者被排除，脱落率为13.33%。治疗反应定义为与治疗前（0周）相比，治疗后（12周）IIEF-5评分增加超过2/3/4分。治疗组的反应率为54/80（67.50%），在12周时显著高于对照组的8/40（20.00%）（全分析集分析）。治疗后4、8和12周，对SEP-3（成功阴道性交）回答为阳性的患者百分比分别为58.97%、64.1%和73.08%，显著高于对照组的28.95%、31.58%和28.95%（全分析集分析，P<0.05）。治疗组GAQ的阳性反应率约为对照组的2至3倍（P<0.05）。未发现与治疗相关的不良事件（AE），包括局部瘀点或瘀斑以及血尿。
当前研究表明，LIPUS可安全有效地治疗轻度至中度ED患者，且无明显不良事件，这与LIPUS的机械力有关，并且可以恢复海绵体的病理变化。LIPUS在不久的将来是一种有前景的ED替代治疗方法，同时有待进一步研究。
