Early Oxybutinin Treatment for Boys With Posterior Urethral Valves
Prospective Randomized Clinical Trial of Early Oxybutinin Treatment for Boys With Posterior Urethral Valves
University Hospital, Bordeaux
50 participants
Sep 10, 2020
INTERVENTIONAL
Conditions
Summary
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. Anticholinergic 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. This study would be the first randomized clinical trial of early therapeutic drug intervention in the posterior urethral valve population.
Eligibility
Inclusion Criteria7
- Boys
- Aged 3 to 6 months
- Diagnosed with posterior urethral valves, and having undergone valve resection within the first 3 months of life
- Children who have had their valve resection at least 3 months before inclusion
- Having undergone urodynamic studies between 10 weeks and 6 months of age andshowing abnormal urodynamics, notably: high voiding pressure (>60cm H2O)/ small capacity bladder (<70% expected bladder volume)and for those without pop-off mechanisms, poor compliance (<10ml/cmH2O)/
- Holders of parental authority affiliated to French national health insurance
- With informed consent signed by holders of parental authority
Exclusion Criteria4
- Boys with posterior urethral valves and normal urodynamics or no urodynamic assessment
- Boys in whom urodynamic assessment is not possible for medical or anatomical reasons
- Boys requiring dialysis before the age of 3 months
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
The Investigational Medicinal Product of this study is Oxybutynin 1 mg/ml 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/kg/twice a day to patients randomized to the study treatment group. The dose will be adapted to the child's weight to the nearest kilogram. The recommended dosage for older children with neurologic bladder is 0.3 to 0.4mg/kg/day, whilst the dosage we will be using is effectively 0.2mg/kg/day. This is because we are taking into account the absence or pharmacological studies of oxybutynin use in children \<1 year of age, as well as their specific liver metabolism. Furthermore, the dose of 0.1mg/kg twice daily is the dose used in children within the same age group in the study by Casey et al, 2012
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04526353