{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,7]],"date-time":"2026-08-07T14:56:44Z","timestamp":1786114604339,"version":"build-2736575974"},"reference-count":30,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2025,11,3]],"date-time":"2025-11-03T00:00:00Z","timestamp":1762128000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,11,3]],"date-time":"2025-11-03T00:00:00Z","timestamp":1762128000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["bjui-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJU International"],"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Neurogenic bladder is defined as a dysfunction of the bladder resulting from damage to the central or peripheral nervous systems. Its treatment is based on a progressive therapeutic escalation, rapidly involving invasive therapeutic procedures such as repeated intradetrusor injections and surgery. Given the risk of repeated general anaesthesia in children, there is a need for non\u2010invasive treatment for young patients who do not respond to or have adverse effects from oral anticholinergic treatment. The \u2018Place de l\u2019OXybutynine Intrav\u00e9sicale chez le Patient Enfant Neurologique\u2019 (POXIPEN) trial aims to assess the efficacy of intra\u2010vesical oxybutynin on bladder capacity in a sample of French children with neurogenic bladder.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study Design<\/jats:title>\n                    <jats:p>The POXIPEN is a multicentre, randomised, double\u2010blind, placebo\u2010controlled trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Endpoints<\/jats:title>\n                    <jats:p>The primary outcome is change in maximal bladder capacity after treatment. Secondary outcomes include changes in voiding, urodynamic and ultrasound parameters. We will also assess changes on quality of life and usability of the product.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Patients and Methods<\/jats:title>\n                    <jats:p>We aim to randomly assign 60 children with neurogenic bladder secondary to spina bifida and deemed non\u2010responders to first\u2010line treatment with oral anticholinergics, to receive intravesical oxybutynin (IVO) or placebo for 4\u2009weeks. Recruitment will start in September 2025. It will be the first prospective study to evaluate the efficacy of IVO in children, with a high level of evidence provided by its design. If IVO proves effective, it could lengthen the delay in therapeutic escalation to invasive procedures, thereby reducing the risk of complications associated with general anaesthesia in children with neurogenic bladder.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      This trial is registered with the European Union (EU) Clinical Trials Information System (CTIS) under EU CT Number: 2022\u2013501\u2009902\u201336\u201000 (approved 09.01.2025) and\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                      under identifier NCT07027020 (registered 18.06.2025).\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/bju.70058","type":"journal-article","created":{"date-parts":[[2025,11,3]],"date-time":"2025-11-03T08:05:16Z","timestamp":1762157116000},"page":"390-398","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Intravesical oxybutynin for bladder capacity in children with spina bifida: the \u2018Place de l\u2019OXybutynine Intrav\u00e9sicale chez le Patient Enfant Neurologique\u2019 (\n                    <scp>POXIPEN)<\/scp>\n                    trial protocol"],"prefix":"10.1111","volume":"137","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3002-6976","authenticated-orcid":false,"given":"Marie","family":"Buzzi","sequence":"first","affiliation":[{"name":"CHRU\u2010Nancy, INSERM, CIC, Epid\u00e9miologie Clinique Universit\u00e9 de Lorraine  Nancy France"},{"name":"Inserm, INSPIIRE Universit\u00e9 de Lorraine  Nancy France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan","family":"Epstein","sequence":"additional","affiliation":[{"name":"CHRU\u2010Nancy, INSERM, CIC, Epid\u00e9miologie Clinique Universit\u00e9 de Lorraine  Nancy France"},{"name":"Inserm, INSPIIRE Universit\u00e9 de Lorraine  Nancy France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zahi","family":"Hatem","sequence":"additional","affiliation":[{"name":"CHRU\u2010Nancy, Pediatric Surgery Department Universit\u00e9 de Lorraine  Nancy France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nadine","family":"Juge","sequence":"additional","affiliation":[{"name":"CHRU\u2010Nancy, INSERM, CIC, Epid\u00e9miologie Clinique Universit\u00e9 de Lorraine  Nancy France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles","family":"Mazeaud","sequence":"additional","affiliation":[{"name":"CHRU\u2010Nancy, Urology Department Universit\u00e9 de Lorraine  Nancy France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean\u2010Louis","family":"Lemelle","sequence":"additional","affiliation":[{"name":"CHRU\u2010Nancy, Pediatric Surgery Department Universit\u00e9 de Lorraine  Nancy France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicolas","family":"Berte","sequence":"additional","affiliation":[{"name":"CHRU\u2010Nancy, Pediatric Surgery Department Universit\u00e9 de Lorraine  Nancy France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,11,3]]},"reference":[{"key":"e_1_2_13_2_1","doi-asserted-by":"publisher","DOI":"10.1590\/s1677-5538.ibju.2020.0989"},{"key":"e_1_2_13_3_1","unstructured":"DITROPAN 5 mg cp s\u00e9c \u2010 VIDAL Hoptimal [Internet]. Available at:https:\/\/hoptimal.vidal.fr\/medicament\/ditropan_5_mg_cp_sec\u20105431.html#effets_indesirables"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-5347(17)41304-8"},{"key":"e_1_2_13_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/sc.1994.5"},{"key":"e_1_2_13_6_1","doi-asserted-by":"publisher","DOI":"10.4172\/2161-0665.1000138"},{"key":"e_1_2_13_7_1","first-page":"660","article-title":"Value of intravesically instilled oxybutynin in refractory bladder hyperactivity. Study of 15 cases","volume":"2","author":"Amarenco G","year":"1992","journal-title":"Prog Urol"},{"key":"e_1_2_13_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-5347(01)62703-4"},{"key":"e_1_2_13_9_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1464-410X.1998.00888.x"},{"key":"e_1_2_13_10_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1464-410x.2001.02227.x"},{"key":"e_1_2_13_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2008.05.056"},{"key":"e_1_2_13_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.22755"},{"key":"e_1_2_13_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/pan.13390"},{"key":"e_1_2_13_14_1","doi-asserted-by":"publisher","DOI":"10.1097\/MPG.0000000000002346"},{"key":"e_1_2_13_15_1","unstructured":"European Association of Urology \u2010 Uroweb. Available at:https:\/\/uroweb.org\/guidelines\/paediatric\u2010urology\/chapter\/the\u2010guideline."},{"key":"e_1_2_13_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.24248"},{"key":"e_1_2_13_17_1","unstructured":"Haute Autorit\u00e9 de Sant\u00e9 \u2013 Prise en charge en m\u00e9decine physique et de r\u00e9adaptation du patient atteint de Spina Bifida [Internet]. Available at:https:\/\/www.has\u2010sante.fr\/jcms\/c_2032137\/fr\/prise\u2010en\u2010charge\u2010en\u2010medecine\u2010physique\u2010et\u2010de\u2010readaptation\u2010du\u2010patient\u2010atteint\u2010de\u2010spina\u2010bifida"},{"key":"e_1_2_13_18_1","unstructured":"Base de Donn\u00e9es Publique des M\u00e9dicaments [Internet]. Available at:https:\/\/base\u2010donnees\u2010publique.medicaments.gouv.fr\/medicament\/60608174\/extrait"},{"key":"e_1_2_13_19_1","unstructured":"DITROPAN\u00ae (oxybutynin chloride) \u2010 Tablets and Syrup [Internet]. Available at:https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2008\/017577s034%2C018211s017%2C020897s018lbl.pdf?utm_source=chatgpt.com"},{"key":"e_1_2_13_20_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.22783"},{"key":"e_1_2_13_21_1","unstructured":"Haute Autorit\u00e9 de Sant\u00e9 [Internet].Avis n\u00b02012.0025\/AC\/SEAP du 3 octobre 2012 du coll\u00e8ge de la Haute Autorit\u00e9 de sant\u00e9 relatif \u00e0 l'acte d\u2019 \u201cInjection de toxine botulique dans la musculeuse v\u00e9sicale par ur\u00e9trocystoscopie\u201d. Available at:https:\/\/www.has\u2010sante.fr\/jcms\/c_1321852\/fr\/avis\u2010n2012\u20100025\/ac\/seap\u2010du\u20103\u2010octobre\u20102012\u2010du\u2010college\u2010de\u2010la\u2010haute\u2010autorite\u2010de\u2010sante\u2010relatif\u2010a\u2010l\u2010acte\u2010d\u2010injection\u2010de\u2010toxine\u2010botulique\u2010dans\u2010la\u2010musculeuse\u2010vesicale\u2010par\u2010uretrocystoscopie"},{"key":"e_1_2_13_22_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.20041"},{"key":"e_1_2_13_23_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-013-0428-3"},{"key":"e_1_2_13_24_1","unstructured":"Investigating the Correspondence Between UMUX\u2010LITE and SUS Scores | Semantic Scholar [Internet]. Available at:https:\/\/www.semanticscholar.org\/paper\/Investigating\u2010the\u2010Correspondence\u2010Between\u2010UMUX\u2010LITE\u2010Lewis\u2010Utesch\/17921b8feda8874a763277cb4de7aa854ac3ad09"},{"key":"e_1_2_13_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2013.05.011"},{"key":"e_1_2_13_26_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.22560"},{"key":"e_1_2_13_27_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrurol.2009.214"},{"key":"e_1_2_13_28_1","doi-asserted-by":"publisher","DOI":"10.14740\/jocmr3752"},{"key":"e_1_2_13_29_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-5347(17)36663-6"},{"key":"e_1_2_13_30_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2003.10.009"},{"key":"e_1_2_13_31_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-158-3-201302050-00583"}],"container-title":["BJU International"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/bjui-journals.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bju.70058","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/bjui-journals.onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/bju.70058","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/bjui-journals.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bju.70058","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,5]],"date-time":"2026-08-05T21:15:08Z","timestamp":1785964508000},"score":1,"resource":{"primary":{"URL":"https:\/\/bjui-journals.onlinelibrary.wiley.com\/doi\/10.1111\/bju.70058"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,11,3]]},"references-count":30,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2026,2]]}},"alternative-id":["10.1111\/bju.70058"],"URL":"https:\/\/doi.org\/10.1111\/bju.70058","archive":["Portico"],"relation":{},"ISSN":["1464-4096","1464-410X"],"issn-type":[{"value":"1464-4096","type":"print"},{"value":"1464-410X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,11,3]]},"assertion":[{"value":"2025-11-03","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}