{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,12]],"date-time":"2026-06-12T20:50:41Z","timestamp":1781297441166,"version":"3.54.1"},"reference-count":25,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2020,1,20]],"date-time":"2020-01-20T00:00:00Z","timestamp":1579478400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004330","name":"GlaxoSmithKline","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004330","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Int J of Urology"],"published-print":{"date-parts":[[2020,3]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>To evaluate the efficacy and safety of onabotulinumtoxinA (botulinum toxin type A) 100\u00a0U in patients with overactive bladder and urinary incontinence.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This was a phase\u00a0III, randomized, double\u2010blind, placebo\u2010controlled trial in Japanese patients who were inadequately managed with overactive bladder medications (anticholinergics and\/or \u03b2<jats:sub>3<\/jats:sub>\u2010adrenergic receptor agonists). Eligible patients were randomized 1:1 to receive a single dose of either onabotulinumtoxinA or placebo into the detrusor muscle (<jats:italic>n<\/jats:italic>\u00a0=\u00a0124 each). The primary end\u2010point was the change in the number of daily urinary incontinence episodes at week\u00a012 from baseline. Secondary end\u2010points included volume voided per micturition, other symptomatic measures (urinary urgency incontinence, micturition, urgency and nocturia) and patient\u2010reported outcomes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In the onabotulinumtoxinA group, there was a significantly greater decrease from baseline in the mean number of daily urinary incontinence episodes compared with the placebo group (2.16; <jats:italic>P<\/jats:italic>\u00a0&lt;\u00a00.001), and significantly greater improvement for all secondary end\u2010points (<jats:italic>P<\/jats:italic>\u00a0&lt;\u00a00.05). Urinary tract infection, dysuria, urinary retention and post\u2010void residual urine volume increased represented adverse events occurring at a higher rate in the onabotulinumtoxinA group. The majority of these were mild or moderate in severity.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Statistically significant and clinically relevant improvements in symptoms and patient\u2010reported outcomes, and tolerability were seen in patients with overactive bladder and urinary incontinence\u00a0who had been\u00a0inadequately managed with overactive bladder medications after using onabotulinumtoxinA.<\/jats:p><\/jats:sec>","DOI":"10.1111\/iju.14176","type":"journal-article","created":{"date-parts":[[2020,1,20]],"date-time":"2020-01-20T10:34:20Z","timestamp":1579516460000},"page":"227-234","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":33,"title":["OnabotulinumtoxinA (botulinum toxin type\u00a0A) for the treatment of Japanese patients with overactive bladder and urinary incontinence: Results of single\u2010dose treatment from a phase\u00a0III, randomized, double\u2010blind, placebo\u2010controlled trial (interim analysis)"],"prefix":"10.1111","volume":"27","author":[{"given":"Osamu","family":"Yokoyama","sequence":"first","affiliation":[{"name":"Department of Urology Faculty of Medical Science University of Fukui Fukui Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masashi","family":"Honda","sequence":"additional","affiliation":[{"name":"Department of Urology Tottori University Faculty of Medicine Tottori Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomonori","family":"Yamanishi","sequence":"additional","affiliation":[{"name":"Department of Urology Dokkyo Medical University Tochigi Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuki","family":"Sekiguchi","sequence":"additional","affiliation":[{"name":"Yokohama Motomachi Women\u2019s Clinic LUNA Kanagawa Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenji","family":"Fujii","sequence":"additional","affiliation":[{"name":"Medicines Development Japan Development Division GlaxoSmithKline Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashi","family":"Nakayama","sequence":"additional","affiliation":[{"name":"Biomedical Data Sciences Department Japan Development Division GlaxoSmithKline Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takao","family":"Mogi","sequence":"additional","affiliation":[{"name":"Medicines Development Japan Development Division GlaxoSmithKline Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,1,20]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.10052"},{"key":"e_1_2_9_3_1","first-page":"S580","article-title":"Overactive bladder significantly affects quality of life","volume":"6","author":"Abrams P","year":"2000","journal-title":"Am. 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