{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T18:23:27Z","timestamp":1791829407172,"version":"4.3.4"},"reference-count":35,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2014,3,17]],"date-time":"2014-03-17T00:00:00Z","timestamp":1395014400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["bjui-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJU International"],"published-print":{"date-parts":[[2014,6]]},"abstract":"\n Objective<\/jats:title>\n \n \n \n \n To evaluate the efficacy and safety of the \u03b2\n 3<\/jats:sub>\n \u2010adrenoceptor agonist mirabegron, in a\n J<\/jats:styled-content>\n apanese population with overactive bladder (\n OAB<\/jats:styled-content>\n ).\n <\/jats:p>\n <\/jats:list-item>\n <\/jats:list>\n <\/jats:p>\n <\/jats:sec>\n \n Patients and Methods<\/jats:title>\n \n \n \n \n This randomised, double\u2010blind, placebo\u2010controlled phase\n III<\/jats:styled-content>\n study enrolled adult patients experiencing\n OAB<\/jats:styled-content>\n symptoms for \u226524 weeks. Patients with \u2265 8 micturitions\/24\u2009h and \u22651 urgency episode\/24\u2009h or \u22651 urgency incontinence episode\/24\u2009h were randomised to once\u2010daily placebo, mirabegron 50\u2009mg or tolterodine 4\u2009mg (as an active comparator, without testing for non\u2010inferiority of efficacy and safety) for 12 weeks.\n <\/jats:p>\n <\/jats:list-item>\n \n \n The primary endpoint was the change in the mean number of micturitions\/24\u2009h from baseline to final assessment. Secondary endpoints included micturition variables related to urgency and\/or incontinence and quality\u2010of\u2010life domain scores on the\n K<\/jats:styled-content>\n ing's\n H<\/jats:styled-content>\n ealth\n Q<\/jats:styled-content>\n uestionnaire.\n <\/jats:p>\n <\/jats:list-item>\n \n \n Safety assessments included adverse events (\n AE<\/jats:styled-content>\n s), post\u2010void residual urine volume, laboratory variables, vital signs and 12\u2010lead electrocardiogram.\n <\/jats:p>\n <\/jats:list-item>\n <\/jats:list>\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n \n \n \n A total of 1139 patients were randomised to receive placebo (\n n<\/jats:italic>\n = 381), mirabegron 50\u2009mg (\n n<\/jats:italic>\n = 380) or tolterodine 4\u2009mg (\n n<\/jats:italic>\n = 378). Demographic and baseline characteristics were similar among the treatment groups.\n <\/jats:p>\n <\/jats:list-item>\n \n \n At final assessment, mirabegron was significantly superior to placebo in terms of mean [\n sd<\/jats:sc>\n ] change from baseline in number of micturitions\/24\u2009h (\u20131.67 [2.212] vs \u20100.86 [2.354];\n P<\/jats:italic>\n < 0.001) and mean [\n sd<\/jats:sc>\n ] change from baseline in number of urgency episodes\/24\u2009h (\u20131.85 [2.555] vs \u20131.37 [3.191];\n P<\/jats:italic>\n = 0.025), incontinence episodes\/24\u2009h (\u20131.12 [1.475] vs \u20130.66 [1.861];\n P<\/jats:italic>\n = 0.003), urgency incontinence episodes\/24\u2009h (\u20131.01 [1.338] vs \u20130.60 [1.745];\n P<\/jats:italic>\n = 0.008), and volume voided\/micturition (24.300 [35.4767] vs 9.715 [29.0864] mL;\n P<\/jats:italic>\n < 0.001).\n <\/jats:p>\n <\/jats:list-item>\n \n \n The incidence of\n AE<\/jats:styled-content>\n s in the mirabegron group was similar to that in the placebo group. Most\n AE<\/jats:styled-content>\n s were mild and none were severe.\n <\/jats:p>\n <\/jats:list-item>\n <\/jats:list>\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n \n \n \n \n Mirabegron 50\u2009mg once daily is an effective treatment for\n OAB<\/jats:styled-content>\n symptoms, with a low occurrence of side effects in a Japanese population.\n <\/jats:p>\n <\/jats:list-item>\n <\/jats:list>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/bju.12649","type":"journal-article","created":{"date-parts":[[2014,1,29]],"date-time":"2014-01-29T00:06:56Z","timestamp":1390954016000},"page":"951-960","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":139,"title":["Phase\n III<\/scp>\n , randomised, double\u2010blind, placebo\u2010controlled study of the \u03b2\n 3<\/sub>\n \u2010adrenoceptor agonist mirabegron, 50\u2009mg once daily, in\n J<\/scp>\n apanese patients with overactive bladder"],"prefix":"10.1111","volume":"113","author":[{"given":"Osamu","family":"Yamaguchi","sequence":"first","affiliation":[{"name":"Division of Bioengineering and LUTD Research School of Engineering Nihon University Koriyama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eiji","family":"Marui","sequence":"additional","affiliation":[{"name":"Department of Human Arts Sciences University and Graduate School of Human Arts Sciences Saitama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hidehiro","family":"Kakizaki","sequence":"additional","affiliation":[{"name":"Department of Urology Asahikawa Medical University Asahikawa Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yukio","family":"Homma","sequence":"additional","affiliation":[{"name":"Department of Urology The University of Tokyo Graduate School of Medicine Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuhiko","family":"Igawa","sequence":"additional","affiliation":[{"name":"Department of Continence Medicine The University of Tokyo Graduate School of Medicine Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masayuki","family":"Takeda","sequence":"additional","affiliation":[{"name":"Department of Urology University of Yamanashi Yamanashi Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Osamu","family":"Nishizawa","sequence":"additional","affiliation":[{"name":"Department of Urology Shinshu University Matsumoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Momokazu","family":"Gotoh","sequence":"additional","affiliation":[{"name":"Department of Urology Nagoya University Graduate School of Medicine Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masaki","family":"Yoshida","sequence":"additional","affiliation":[{"name":"Department of Urology National Center for Geriatrics and Gerontology Obu Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Osamu","family":"Yokoyama","sequence":"additional","affiliation":[{"name":"Department of Urology University of Fukui Faculty of Medical Sciences Fukui Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Narihito","family":"Seki","sequence":"additional","affiliation":[{"name":"Department of Urology Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers Fukuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasushi","family":"Ikeda","sequence":"additional","affiliation":[{"name":"Astellas Pharma Inc. 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