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However, large-scale clinical trials are needed to verify its efficacy and safety and determine a reasonable treatment interval.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Outcomes<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>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 \u22120.01% [95% confidence interval \u22120.11 to 0.10%] within the acceptable margin (\u221214.0%). No significant difference was found among secondary outcomes. IIEF-EF score showed a significant increase from baseline in the 3\/W group (16.8 to 20.7) and 2\/W group (17.8 to 21.7), and the percentage of patients with EHS \u22653 increased in the 3\/W (54.9% to 84.0%) and 2\/W (59.5% to 83.5%) groups. There was no significant difference in response rate between the 2 groups after controlling for strata factors and homogeneous tests. No treatment-related adverse events were reported.<\/jats:p><\/jats:sec><jats:sec><jats:title>Clinical Implications<\/jats:title><jats:p>Low-intensity pulsed ultrasound therapy displays similar efficacy and safety for mild-to-moderate ED when administered thrice or twice per week for 16 sessions. This study provides two options to suit patients\u2019 needs.<\/jats:p><\/jats:sec><jats:sec><jats:title>Strengths &amp; Limitations<\/jats:title><jats:p>This is a large-sample, randomized, controlled, noninferiority trial study. Short-term follow-up and mostly younger patients are the main limitations.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Low-intensity pulsed ultrasound therapy thrice and twice per week showed equivalent therapeutic effects and safety for mild-to-moderate ED in a young and generally healthy population. This therapy warrants further investigation of its potential value in rehabilitation of ED.<\/jats:p><\/jats:sec>","DOI":"10.1016\/j.jsxm.2022.06.009","type":"journal-article","created":{"date-parts":[[2022,8,20]],"date-time":"2022-08-20T23:32:52Z","timestamp":1661038372000},"page":"1536-1545","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":17,"title":["The Efficacy and Safety of Thrice vs Twice per Week Low-Intensity Pulsed Ultrasound Therapy for Erectile Dysfunction: A Randomized Clinical Trial"],"prefix":"10.1093","volume":"19","author":[{"given":"Huirong","family":"Chen","sequence":"first","affiliation":[{"name":"Clinical Medical Center of Urology, Institute of Urology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine , Shanghai , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zheng","family":"Li","sequence":"additional","affiliation":[{"name":"Clinical Medical Center of 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