[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100402904":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":48,"locations":58,"responsibleParty":74,"collaborators":18,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":18,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":61,"whyStopped":18,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"University Hospital, Bordeaux","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Oxybutynin during 9 months.","EXPERIMENTAL","0.1mg \u002F kg 2x \u002F day from inclusion and for 9 months.",[13],"Drug: Oxybutynin 1 mg\u002Fml Syrup",{"label":15,"type":16,"description":17,"interventionNames":18},"No oxybutynin","NO_INTERVENTION","No treatment affecting bladder function",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Oxybutynin 1 mg\u002Fml Syrup","The Investigational Medicinal Product of this study is Oxybutynin 1 mg\u002Fml Syrup (see Annex 1 for the Monograph of PMS-Oxybutynin provided by ANSM under the ATU.). It will be administered at the dose of 0.1 mg\u002Fkg\u002Ftwice a day to patients randomized to the study treatment group. The dose will be adapted to the child's weight to the nearest kilogram.\n\nThe recommended dosage for older children with neurologic bladder is 0.3 to 0.4mg\u002Fkg\u002Fday, whilst the dosage we will be using is effectively 0.2mg\u002Fkg\u002Fday. This is because we are taking into account the absence or pharmacological studies of oxybutynin use in children \\\u003C1 year of age, as well as their specific liver metabolism. Furthermore, the dose of 0.1mg\u002Fkg twice daily is the dose used in children within the same age group in the study by Casey et al, 2012",[9],[26,30,33,36,39,42,45],{"name":27,"affiliation":28,"role":29},"Laurent L FOURCADE, MD","University Hospital, Limoges","PRINCIPAL_INVESTIGATOR",{"name":31,"affiliation":32,"role":29},"Alice A FAURE, MD","APHM - Hôpital Timone Enfants",{"name":34,"affiliation":35,"role":29},"Thomas BLANC, MD","APHP - Hôpital Necker Enfants Malades",{"name":37,"affiliation":38,"role":29},"Alaa A EL GHONEIMI, MD","APHP- Hôpital Robert Debré",{"name":40,"affiliation":41,"role":29},"Alexis A ARNAUD, MD","Rennes University Hospital",{"name":43,"affiliation":44,"role":29},"Ourdia O BOUALI, MD","University Hospital, Toulouse",{"name":46,"affiliation":47,"role":29},"Jean-Baptiste JB MARRET, MD","University Hospital, Caen",[49,54],{"name":50,"role":51,"phone":52,"phoneExt":18,"email":53},"Luke L HARPER, MD","CONTACT","05 56 79 56 17","luke.harper@chu-bordeaux.fr",{"name":55,"role":51,"phone":56,"phoneExt":18,"email":57},"Aurore A CAPELLI, PhD","05 57 82 08 77","aurore.capelli@chu-bordeaux.fr",[59],{"facility":60,"status":61,"city":62,"state":18,"zip":18,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"CHU de Bordeaux","RECRUITING","Bordeaux","France","FR",{"type":66,"coordinates":67},"Point",[68,69],-0.58046,44.84124,{"lat":69,"lon":68},[72],{"name":50,"role":51,"phone":73,"phoneExt":18,"email":53},"+33 05 56 79 56 17",{"type":75,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100402904","phase-2-early-oxybutinin-treatment-for-boys-with-posterior-urethral-valves-100402904",false,"NCT04526353","Early Oxybutinin Treatment for Boys With Posterior Urethral Valves","Prospective Randomized Clinical Trial of Early Oxybutinin Treatment for Boys With Posterior Urethral Valves","PRETIPUV","Inclusion Criteria:\n\n* Boys\n* Aged 3 to 6 months\n* Diagnosed with posterior urethral valves, and having undergone valve resection within the first 3 months of life\n* Children who have had their valve resection at least 3 months before inclusion\n* Having undergone urodynamic studies between 10 weeks and 6 months of age andshowing abnormal urodynamics, notably: high voiding pressure (\\>60cm H2O)\u002F small capacity bladder (\\\u003C70% expected bladder volume)and for those without pop-off mechanisms, poor compliance (\\\u003C10ml\u002FcmH2O)\u002F\n* Holders of parental authority affiliated to French national health insurance\n* With informed consent signed by holders of parental authority\n\nExclusion Criteria:\n\n* Boys with posterior urethral valves and normal urodynamics or no urodynamic assessment\n* Boys in whom urodynamic assessment is not possible for medical or anatomical reasons\n* Boys requiring dialysis before the age of 3 months\n* Contra-indication to oxybutynin such as hypersensitivity to oxybutynin or any of the excipients, digestive obstruction, occlusive or sub-occlusive syndrome, megacolon, digestive stasis, intestinal atony, paralytic ileus, ulcerative colitis, Hemorrhagic rectocolitis, Crohn's disease, Inflammatory bowel disease, Inflammatory organic colopathy, myasthenia, congenital glaucoma","MALE","3 Months","6 Months",{"count":88,"type":89},50,"ESTIMATED","INTERVENTIONAL",[92],"PHASE2","Boys with posterior urethral valves have bladder dysfunction of varying severity. Early treatment of these children with anticholinergics is recommended by some teams, although there have never been any clear studies on the subject. To our knowledge, no comparative study of the evolution of valve bladders with or without treatment has been carried out to date.\n\nAnticholinergic treatment, although it may be beneficial in patients with abnormal bladder function, such as the neurologic bladders ( in Spina Bifida) for example, may have side effects and may not be of benefit for this valve population. The evolution of the valves could be spontaneously favorable.\n\nThis study would be the first randomized clinical trial of early therapeutic drug intervention in the posterior urethral valve population.",[95],"Male Urogenital Diseases",[97,98,99],"posterior urethral valves","urodynamic","anticholinergic","2026-06-08",{"date":102,"type":103},"2026-06-10","ACTUAL",{"date":105,"type":103},"2020-09-10",{"date":107,"type":89},"2028-09-10",{"name":5,"class":6},1]