PMID- 31555554 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220410 IS - 2223-4691 (Print) IS - 2223-4691 (Electronic) IS - 2223-4683 (Linking) VI - 8 IP - 4 DP - 2019 Aug TI - Efficacy and safety of novel low-intensity pulsed ultrasound (LIPUS) in treating mild to moderate erectile dysfunction: a multicenter, randomized, double-blind, sham-controlled clinical study. PG - 307-319 LID - 10.21037/tau.2019.07.03 [doi] AB - BACKGROUND: 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. METHODS: 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)]. RESULTS: 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. CONCLUSIONS: 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. FAU - Cui, Wanshou AU - Cui W AD - Andrology Center, Peking University First Hospital, Beijing 100034, China. FAU - Li, Huixi AU - Li H AD - Andrology Center, Peking University First Hospital, Beijing 100034, China. FAU - Guan, Ruili AU - Guan R AD - Andrology Center, Peking University First Hospital, Beijing 100034, China. FAU - Li, Meng AU - Li M AD - Andrology Center, Peking University First Hospital, Beijing 100034, China. FAU - Yang, Bicheng AU - Yang B AD - Andrology Center, Peking University First Hospital, Beijing 100034, China. FAU - Xu, Zhanwei AU - Xu Z AD - Wanbeili Medical instrument Co., Ltd., Beijing 102200, China. FAU - Lin, Maofan AU - Lin M AD - Wanbeili Medical instrument Co., Ltd., Beijing 102200, China. FAU - Tian, Long AU - Tian L AD - Department of Urology, Beijing Chaoyang Hospital, Beijing 100020, China. FAU - Zhang, Xiaodong AU - Zhang X AD - Department of Urology, Beijing Chaoyang Hospital, Beijing 100020, China. FAU - Li, Bao AU - Li B AD - Department of Urology, Affiliated Hospital of Weifang Medical University, Weifang 261031, China. FAU - Liu, Weiguang AU - Liu W AD - Department of Urology, Affiliated Hospital of Weifang Medical University, Weifang 261031, China. FAU - Dong, Zhilong AU - Dong Z AD - Department of Urology, Lanzhou University Second Hospital, Lanzhou 730030, China. FAU - Wang, Zhiping AU - Wang Z AD - Department of Urology, Lanzhou University Second Hospital, Lanzhou 730030, China. FAU - Zheng, Tao AU - Zheng T AD - Department of Urology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China. FAU - Zhang, Weixing AU - Zhang W AD - Department of Urology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China. FAU - Lin, Guiting AU - Lin G AD - Knuppe Molecular Urology Laboratory, Department of Urology, School of Medicine, University of California, San Francisco, CA, USA. FAU - Guo, Yinglu AU - Guo Y AD - Andrology Center, Peking University First Hospital, Beijing 100034, China. FAU - Xin, Zhongcheng AU - Xin Z AD - Andrology Center, Peking University First Hospital, Beijing 100034, China. LA - eng PT - Journal Article PL - China TA - Transl Androl Urol JT - Translational andrology and urology JID - 101581119 PMC - PMC6732092 OTO - NOTNLM OT - IIEF-5 score OT - Low-intensity pulsed ultrasound (LIPUS) OT - erectile dysfunction (ED) OT - pain assessment OT - treatment COIS- Conflicts of Interest: The authors have no conflicts of interest to declare. EDAT- 2019/09/27 06:00 MHDA- 2019/09/27 06:01 PMCR- 2019/08/01 CRDT- 2019/09/27 06:00 PHST- 2019/09/27 06:00 [entrez] PHST- 2019/09/27 06:00 [pubmed] PHST- 2019/09/27 06:01 [medline] PHST- 2019/08/01 00:00 [pmc-release] AID - tau-08-04-307 [pii] AID - 10.21037/tau.2019.07.03 [doi] PST - ppublish SO - Transl Androl Urol. 2019 Aug;8(4):307-319. doi: 10.21037/tau.2019.07.03.