Masato Shirai, Masataka Sano, Yuta Anno, Keisuke Ishikawa, Ayumu Taniguchi, Akimasa Kure, Yuka Uesaka, Taiji Nozaki, Shinichiro Fukuhara, Atsushi Iwasa, Kazuhiro Kobayashi, Jun Kato, Akira Tsujimura
{"title":"新型真空勃起装置(Vigor 2020)对勃起功能障碍的疗效:日本的一项回顾性研究","authors":"Masato Shirai, Masataka Sano, Yuta Anno, Keisuke Ishikawa, Ayumu Taniguchi, Akimasa Kure, Yuka Uesaka, Taiji Nozaki, Shinichiro Fukuhara, Atsushi Iwasa, Kazuhiro Kobayashi, Jun Kato, Akira Tsujimura","doi":"10.1111/iju.15574","DOIUrl":null,"url":null,"abstract":"ObjectivesThe vacuum erection device (VED) is a second‐line treatment tool recommended in erectile dysfunction (ED) guidelines but has long been unavailable in Japan. A new VED, Vigor 2020<jats:sup>®</jats:sup> (A & HB Company Limited, Tokyo, Japan), has now been manufactured and received medical approval from the Pharmaceuticals and Medical Devices Agency in Japan. We conducted a retrospective observational study of ED patients who used Vigor 2020 in clinical practice.MethodsWe analyzed male ED patients aged ≥20 years treated with Vigor 2020 in our outpatient clinics. The primary endpoint was improvement of erection as evaluated by an Erection Hardness Score (EHS) of ≥1 point. Secondary endpoints were improvement of sexual function and adverse events as evaluated by the International Index of Erectile Function (IIEF) and Male Sexual Health Questionnaire for assessing ejaculatory dysfunction (MSHQ‐EjD).ResultsThirty‐three patients (mean age, 57.21 [27–86] years) could be evaluated before and after using Vigor 2020. Among the 16 patients with baseline EHS ≤2, 14 (93.33%) improved by ≥1 point, and 10 of these 16 patients (62.50%) improved to EHS ≥3 and could insert vaginally. Significant improvement was observed for IIEF total score and for the MSHQ‐EjD in patients with an EHS of ≥3 after use of Vigor 2020. No patient experienced significant adverse events.ConclusionsThe Vigor 2020 may be an efficacious treatment tool for ED. Patients with significant ED experienced not only significant improvement of erection but also improvement of ejaculation with its use.","PeriodicalId":14323,"journal":{"name":"International Journal of Urology","volume":"112 1","pages":""},"PeriodicalIF":1.8000,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy of a new vacuum erection device (Vigor 2020) for erectile dysfunction: A retrospective study in Japan\",\"authors\":\"Masato Shirai, Masataka Sano, Yuta Anno, Keisuke Ishikawa, Ayumu Taniguchi, Akimasa Kure, Yuka Uesaka, Taiji Nozaki, Shinichiro Fukuhara, Atsushi Iwasa, Kazuhiro Kobayashi, Jun Kato, Akira Tsujimura\",\"doi\":\"10.1111/iju.15574\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"ObjectivesThe vacuum erection device (VED) is a second‐line treatment tool recommended in erectile dysfunction (ED) guidelines but has long been unavailable in Japan. A new VED, Vigor 2020<jats:sup>®</jats:sup> (A & HB Company Limited, Tokyo, Japan), has now been manufactured and received medical approval from the Pharmaceuticals and Medical Devices Agency in Japan. We conducted a retrospective observational study of ED patients who used Vigor 2020 in clinical practice.MethodsWe analyzed male ED patients aged ≥20 years treated with Vigor 2020 in our outpatient clinics. The primary endpoint was improvement of erection as evaluated by an Erection Hardness Score (EHS) of ≥1 point. Secondary endpoints were improvement of sexual function and adverse events as evaluated by the International Index of Erectile Function (IIEF) and Male Sexual Health Questionnaire for assessing ejaculatory dysfunction (MSHQ‐EjD).ResultsThirty‐three patients (mean age, 57.21 [27–86] years) could be evaluated before and after using Vigor 2020. Among the 16 patients with baseline EHS ≤2, 14 (93.33%) improved by ≥1 point, and 10 of these 16 patients (62.50%) improved to EHS ≥3 and could insert vaginally. Significant improvement was observed for IIEF total score and for the MSHQ‐EjD in patients with an EHS of ≥3 after use of Vigor 2020. No patient experienced significant adverse events.ConclusionsThe Vigor 2020 may be an efficacious treatment tool for ED. Patients with significant ED experienced not only significant improvement of erection but also improvement of ejaculation with its use.\",\"PeriodicalId\":14323,\"journal\":{\"name\":\"International Journal of Urology\",\"volume\":\"112 1\",\"pages\":\"\"},\"PeriodicalIF\":1.8000,\"publicationDate\":\"2024-09-10\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Urology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1111/iju.15574\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"UROLOGY & NEPHROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Urology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/iju.15574","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}
引用次数: 0
摘要
目标真空勃起装置 (VED) 是勃起功能障碍 (ED) 指南推荐的二线治疗工具,但在日本长期以来一直没有供应。新型真空勃起器 Vigor 2020® (A & HB Company Limited, Tokyo, Japan) 现已生产,并获得了日本药品和医疗器械管理局的医疗认证。我们对门诊中使用 Vigor 2020 治疗的年龄≥20 岁的男性 ED 患者进行了回顾性观察研究。主要终点是通过勃起硬度评分(EHS)≥1 分来评估勃起改善情况。次要终点是性功能和不良事件的改善,通过国际勃起功能指数(IIEF)和男性性健康问卷(MSHQ-EjD)评估射精功能障碍。在基线 EHS ≤2 的 16 名患者中,14 人(93.33%)的 EHS 改善了≥1 点,其中 10 人(62.50%)的 EHS 改善了≥3 点,可以经阴道插入。使用 Vigor 2020 后,EHS ≥3 的患者的 IIEF 总分和 MSHQ-EjD 均有显著改善。结论 Vigor 2020 可能是治疗 ED 的有效工具。使用 Vigor 2020 后,患有严重 ED 的患者不仅能明显改善勃起,还能改善射精。
Efficacy of a new vacuum erection device (Vigor 2020) for erectile dysfunction: A retrospective study in Japan
ObjectivesThe vacuum erection device (VED) is a second‐line treatment tool recommended in erectile dysfunction (ED) guidelines but has long been unavailable in Japan. A new VED, Vigor 2020® (A & HB Company Limited, Tokyo, Japan), has now been manufactured and received medical approval from the Pharmaceuticals and Medical Devices Agency in Japan. We conducted a retrospective observational study of ED patients who used Vigor 2020 in clinical practice.MethodsWe analyzed male ED patients aged ≥20 years treated with Vigor 2020 in our outpatient clinics. The primary endpoint was improvement of erection as evaluated by an Erection Hardness Score (EHS) of ≥1 point. Secondary endpoints were improvement of sexual function and adverse events as evaluated by the International Index of Erectile Function (IIEF) and Male Sexual Health Questionnaire for assessing ejaculatory dysfunction (MSHQ‐EjD).ResultsThirty‐three patients (mean age, 57.21 [27–86] years) could be evaluated before and after using Vigor 2020. Among the 16 patients with baseline EHS ≤2, 14 (93.33%) improved by ≥1 point, and 10 of these 16 patients (62.50%) improved to EHS ≥3 and could insert vaginally. Significant improvement was observed for IIEF total score and for the MSHQ‐EjD in patients with an EHS of ≥3 after use of Vigor 2020. No patient experienced significant adverse events.ConclusionsThe Vigor 2020 may be an efficacious treatment tool for ED. Patients with significant ED experienced not only significant improvement of erection but also improvement of ejaculation with its use.
期刊介绍:
International Journal of Urology is the official English language journal of the Japanese Urological Association, publishing articles of scientific excellence in urology. Submissions of papers from all countries are considered for publication. All manuscripts are subject to peer review and are judged on the basis of their contribution of original data and ideas or interpretation.