The Efficacy and Safety of Thrice vs Twice per Week Low-Intensity Pulsed Ultrasound Therapy for Erectile Dysfunction: A Randomized Clinical Trial

作者：Huirong Chen, Zheng Li, Xianchen Li, Yong Yang, Yutian Dai, Zuogang Xie, Jiaquan Xiao, Xiaoqiang Liu, Luo Yang, Chenkun Shi, Erlei Zhi, Ruhui Tian, Peng Li, Huixing Chen, Zhao Fujun, Jianlin Hu, Chencheng Yao, Guiting Lin, Tom F. Lue, Shujie Xia · 发表于：The Journal of Sexual Medicine · 年份：2022 · DOI：10.1016/j.jsxm.2022.06.009 · 被引用次数：15 · 研究领域：Sexual function and dysfunction studies、Urinary Bladder and Prostate Research、Pediatric Pain Management Techniques

BACKGROUND: A recent sham-controlled clinical study has shown that low-intensity pulsed ultrasound twice per week can safely and effectively treat patients with mild-to-moderate erectile dysfunction (ED). However, large-scale clinical trials are needed to verify its efficacy and safety and determine a reasonable treatment interval. AIM: To study whether low-intensity pulsed ultrasound therapy thrice per week is non-inferior to twice per week in patients with mild-to-moderate ED. METHODS: A randomized, open-label, parallel-group, non-inferiority clinical trial was conducted in 7 hospitals in China. A total of 323 patients with mild-to-moderate ED were randomized (1:1) into thrice per week (3/W) and twice per week (2/W) groups. Low-intensity pulsed ultrasound was applied on each side of the penis for 16 sessions. OUTCOMES: The primary outcome was response rate using the minimal clinically important difference in the International Index of Erectile Function (IIEF-EF) score at week 12. Secondary outcomes included Erection Hardness Score (EHS), Sexual Encounter Profile, Global Assessment Question, and Self Esteem and Relationship Questionnaire. RESULTS: Response rates in 3/W and 2/W groups were 62.0% and 62.5%, respectively. Treatment effect in the 3/W group was noninferior to that of the 2/W group, with rate difference lower bound of -0.01% [95% confidence interval -0.11 to 0.10%] within the acceptable margin (-14.0%). No significant difference was found among secondary outcomes....