{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T15:21:38Z","timestamp":1788189698618,"version":"build-2803163510"},"reference-count":25,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2021,5,31]],"date-time":"2021-05-31T00:00:00Z","timestamp":1622419200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004948","name":"Astellas Pharma","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004948","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Neurourology and Urodynamics"],"published-print":{"date-parts":[[2021,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>To evaluate the efficacy and safety of mirabegron in children and adolescents (aged 3 to &lt;18 years) with neurogenic detrusor overactivity (NDO) using clean intermittent catheterization.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this open\u2010label, multicenter, baseline\u2010controlled, Phase III study (NCT02751931), participants received once\u2010daily mirabegron at an adult dose equivalent of 25\u2009mg. Dose was increased to 50\u2009mg equivalent unless there were safety\/tolerability concerns. The primary efficacy endpoint was change from baseline to Week 24 in maximum cystometric capacity (MCC). Secondary urodynamic assessments, Pediatric Incontinence Questionnaire (PIN\u2010Q), Patient Global Impression of Severity (PGI\u2010S), Clinician Global Impression of Change (CGI\u2010C), and Acceptability questionnaires were included.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Overall, 86 participants (55 aged 3 to &lt;12 years, 31 aged 12 to &lt;18 years) received treatment; 68 were included in efficacy assessments. A statistically significant increase in MCC from baseline to Week 24 was observed (87.20\u2009ml, 95% confidence interval: 66.07, 108.33;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u2009.001); this increase was apparent from Week 4. Significant increases in bladder compliance, bladder volume until first detrusor contraction, average volume per catheterization, maximum daytime catheterized volume and number of dry days per week. Significant decreases in detrusor pressure and number of leakage episodes per day were also observed. Significant improvement in PGI\u2010S but not PIN\u2010Q was observed. Most participants reported their condition had either much or very much improved using the CGI\u2010C. Mirabegron was well tolerated in this population with a profile aligned with that in adults.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Mirabegron was effective and well\u2010tolerated in the treatment of pediatric patients with NDO.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/nau.24657","type":"journal-article","created":{"date-parts":[[2021,6,1]],"date-time":"2021-06-01T00:41:43Z","timestamp":1622508103000},"page":"1490-1499","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":25,"title":["Efficacy and safety of mirabegron in children and adolescents with neurogenic detrusor overactivity: An open\u2010label, phase 3, dose\u2010titration study"],"prefix":"10.1002","volume":"40","author":[{"given":"Ma\u0142gorzata","family":"Baka\u2010Ostrowska","sequence":"first","affiliation":[{"name":"Department of Pediatric Urology The Children's Memorial Health Institute  Warsaw Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David T.","family":"Bolong","sequence":"additional","affiliation":[{"name":"Section of Pediatric Urology Philippine Children's Medical Centre  Manila Philippines"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristian","family":"Persu","sequence":"additional","affiliation":[{"name":"Carol Davila University of Medicine and Pharmacy  Bucharest Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Camilla","family":"T\u00f8ndel","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Haukeland University Hospital  Bergen Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Achim","family":"Steup","sequence":"additional","affiliation":[{"name":"Astellas Pharma US, Inc.  Northbrook Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher","family":"Lademacher","sequence":"additional","affiliation":[{"name":"Astellas Pharma US, Inc.  Northbrook Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nancy","family":"Martin","sequence":"additional","affiliation":[{"name":"Astellas Pharma US, Inc.  Northbrook Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,5,31]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.22751"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00467-008-0764-7"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1038\/sc.1995.73"},{"key":"e_1_2_8_5_1","first-page":"527","article-title":"Bladder management for adults with spinal cord injury: a clinical practice guideline for health\u2010care providers","volume":"29","author":"Consortium for Spinal Cord Medicine","year":"2006","journal-title":"J Spinal Cord Med"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40272-017-0249-x"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.5152\/tud.2019.19070"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00467-007-0691-z"},{"issue":"2","key":"e_1_2_8_9_1","first-page":"180.e1\u2010180.e8","article-title":"Long\u2010term efficacy and safety of solifenacin in pediatric patients aged 6 months to 18 years with neurogenic detrusor overactivity: results from two phase 3 prospective open\u2010label studies","volume":"16","author":"Franco I","year":"2019","journal-title":"J Pediatr Urol"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-5347(05)64115-8"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2018.03.020"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpeds.2009.01.074"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.22505"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1177\/1756287217702797"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12877-020-1474-7"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1038\/sc.2015.195"},{"key":"e_1_2_8_17_1","first-page":"7","article-title":"[Efficacy of combination therapy with mirabegron for anticholinergic\u2010resistant neurogenic bladder: videourodynamic evaluation]","volume":"61","author":"Wada N","year":"2015","journal-title":"Hinyokika Kiyo"},{"key":"e_1_2_8_18_1","volume-title":"Paper presented at ICS2014 \u2010 44th Annual Meeting of the International Continence Society (ICS)","author":"Skobejko L","year":"2014"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpurol.2019.10.009"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.114.S2.555"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2017-1904"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(10)62226-X"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-5347(17)54449-3"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-5347(05)67730-0"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11255-013-0423-1"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.22560"}],"container-title":["Neurourology and Urodynamics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/nau.24657","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/nau.24657","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/nau.24657","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,25]],"date-time":"2023-08-25T12:15:30Z","timestamp":1692965730000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/nau.24657"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,5,31]]},"references-count":25,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2021,8]]}},"alternative-id":["10.1002\/nau.24657"],"URL":"https:\/\/doi.org\/10.1002\/nau.24657","archive":["Portico"],"relation":{},"ISSN":["0733-2467","1520-6777"],"issn-type":[{"value":"0733-2467","type":"print"},{"value":"1520-6777","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,5,31]]},"assertion":[{"value":"2020-09-30","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-03-05","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-05-31","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}