PMID- 35813628 OWN - NLM STAT- MEDLINE DCOM- 20220712 LR - 20220803 IS - 1664-2392 (Print) IS - 1664-2392 (Electronic) IS - 1664-2392 (Linking) VI - 13 DP - 2022 TI - The Efficacy of Li-ESWT Combined With VED in Diabetic ED Patients Unresponsive to PDE5is: A Single-Center, Randomized Clinical Trial. PG - 937958 LID - 10.3389/fendo.2022.937958 [doi] LID - 937958 AB - INTRODUCTION: Phosphodiesterase type 5-inhibitors (PDE5is) are the first-line treatment for patients with diabetes mellitus-induced erectile dysfunction (DMED), however, some patients are non-responser to PDE5is. We performed a perspective, randomized, comparative study to explore the efficacy of low intensity extracorporeal shock wave treatment (Li-ESWT) combined with vacuum erectile device (VED) in the treatment of DMED patients who were unresponsive to PDE5is. METHODS: One hundred and five eligible patients were randomly divided into three groups: group A (VED), group B (Li-ESWT) and group C (VED plus Li-ESWT). Follow-up was conducted at 4 weeks, 8 weeks and 12 weeks after the end of treatment. The erectile function was estimated by the international index of erectile function-erectile function domain (IIEF-EF), erection hardness score (EHS), sexual encounter profile questions 2 and 3 (SEP2 and SEP3) and global assessment question 1 and 2 (GAQ1 and GAQ2) before and after treatment. The changes of five points in IIEF-EF were calculated as the minimal clinical important difference (MCID), which was considered as the main index of efficacy. RESULTS: The MCID was achieved in 14.7%, 14.7% and 17.6% patients in group A at the follow up on 4 weeks, 8 weeks and 12 weeks, respectively (36.4%, 39.4% and 36.4% in group B; 36.4%, 51.5%, and 66.7% in group C). There were significant differences in the percentage of MCID cases between group A and group C at the follow up on 12 weeks (P<0.001), as well as that between group B and group C (P=0.014). Additionally, comparison in MCID within group C showed that there were significant differences between 4 weeks and 12 weeks follow-up (P=0.014). CONCLUSION: Our findings indicated the combined therapy Li-ESWT and VED was more beneficial to shift turn PDE5is non-responders to responders for moderate patients with DMED than VED or Li-ESWT monotherapy. Moreover, this study provided evidence that patients with DMED who failed after taking oral PDE5is could attempt to opt for an alternative physicotherapy (Li-ESWT or VED) prior to more invasive alternatives. CI - Copyright (c) 2022 Tao, Chen, Wang, Li, Xiang, Xiong, Ji, Wu, Zhou, Jia, Lv, Yang and Tang. FAU - Tao, Rongzhen AU - Tao R AD - Department of Urology, The Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing, China. FAU - Chen, Jianhuai AU - Chen J AD - Department of Andrology, Jiangsu Province Hospital of Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China. FAU - Wang, Dujian AU - Wang D AD - Department of Urology, The Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing, China. FAU - Li, Yunpeng AU - Li Y AD - Department of Urology, The Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing, China. FAU - Xiang, Jun AU - Xiang J AD - Department of Ultrasound, The Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing, China. FAU - Xiong, Lei AU - Xiong L AD - Department of Urology, The Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing, China. FAU - Ji, Junbiao AU - Ji J AD - Department of Urology, The Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing, China. FAU - Wu, Jie AU - Wu J AD - Department of Urology, The Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing, China. FAU - Zhou, Shuang AU - Zhou S AD - Department of Urology, The Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing, China. FAU - Jia, Chunping AU - Jia C AD - Department of Urology, The Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing, China. FAU - Lv, Jianlin AU - Lv J AD - Department of Urology, The Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing, China. FAU - Yang, Jie AU - Yang J AD - Department of Urology, Jiangsu Provincial People's Hospital, First Affiliated Hospital of Nanjing Medical University, Nanjing, China. AD - Department of Urology, People's Hospital of Xinjiang Kizilsu Kirgiz Autonomous Prefecture, Xinjiang, China. FAU - Tang, Qinglai AU - Tang Q AD - Department of Urology, The Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing, China. LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20220623 PL - Switzerland TA - Front Endocrinol (Lausanne) JT - Frontiers in endocrinology JID - 101555782 RN - 0 (Phosphodiesterase 5 Inhibitors) SB - IM MH - *Diabetes Mellitus/drug therapy MH - *Erectile Dysfunction/drug therapy/therapy MH - Humans MH - Male MH - Penile Erection MH - Phosphodiesterase 5 Inhibitors/therapeutic use MH - Treatment Outcome PMC - PMC9259797 OTO - NOTNLM OT - diabetes mellitus OT - erectile dysfunction OT - low intensity extracorporeal shock wave treatment OT - phosphodiesterase type 5-inhibitors OT - vacuum erectile device COIS- The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2022/07/12 06:00 MHDA- 2022/07/14 06:00 PMCR- 2022/01/01 CRDT- 2022/07/11 04:05 PHST- 2022/05/06 00:00 [received] PHST- 2022/05/23 00:00 [accepted] PHST- 2022/07/11 04:05 [entrez] PHST- 2022/07/12 06:00 [pubmed] PHST- 2022/07/14 06:00 [medline] PHST- 2022/01/01 00:00 [pmc-release] AID - 10.3389/fendo.2022.937958 [doi] PST - epublish SO - Front Endocrinol (Lausanne). 2022 Jun 23;13:937958. doi: 10.3389/fendo.2022.937958. eCollection 2022.