Early Oxybutinin Treatment for Boys With Posterior Urethral Valves

Posterior urethral valves (VUPs) are the leading cause of subvesical obstruction in children with an incidence between 1 / 3,000 to 1 / 8,000 births. 25-45% of patients will have chronic renal failure and 10-20% will require a transplant. The association between long-term prognosis and bladder dysfunction is well known, leading many teams to suggest early initiation of treatment with anticholinergics.

However, this treatment has never been properly evaluated. In fact, a single study carried out in boys with valves taking oxybutynin from the age of 3 months to 2 years without a control group concluded that "the early use of anticholinergics in boys with VUP presenting high voiding pressures and low bladder capacity has a beneficial effect on bladder function. It is true that in children with neurologic bladders as in Spina Bifida, early treatment with anticholinergics seems to provide a benefit, but VUPs are not strictly speaking neurologic bladders. In addition, treatment with anticholinergics can have side effects and could even be harmful to the bladder, leading to myogenic bankruptcy. The only way to properly assess oxybutynin in this population is to conduct a prospective randomized study.

The proposed study includes a group treated with oxybutynin and a group without. Boys who have had valve resection for VUP within the first three months of life and who present an abnormal urodynamic assessment 3 months after valve resection will be included. Oxybutynin will be given at a dose of 0.1 mg / kg 2x / day, as syrup, in the treatment group. The control group will not have any treatment affecting bladder function. The pharmacokinetics of oxybutynin will be studied. Several urodynamic parameters including capacity or volume, voiding pressure and compliance will be studied. The objective is to perform a composite analysis that can reflect the complex functioning of the bladder. The children included will have urodynamics at the end of the study, after 9 months of treatment. The performance of urodynamic examinations will be standardized and there will be an external centralized analysis to validate the urodynamic results.

• Proportion of adverse events in each group [Срок оценки: through study completion, an average of 9 months]
• Type of adverse events in each group [Срок оценки: through study completion, an average of 9 months]
• Incidence of urinary tract infections in each group [Срок оценки: through study completion, an average of 9 months]
• Compliance with treatment [Срок оценки: 9 months after inclusion]
• Sonographic changes [Срок оценки: 9 months after inclusion]
• Area under the plasma concentration versus time curve (AUC) of oxybutynin in treated boys over treatment [Срок оценки: through study completion, an average of 9 months]
• Peak Plasma Concentration (Cmax) of oxybutynin in treated boys over treatment [Срок оценки: through study completion, an average of 9 months]
• Minimum plasma concentration (Cmin) of oxybutynin in treated boys over treatment [Срок оценки: through study completion, an average of 9 months]
• Half-life of oxybutynin in treated boys over treatment [Срок оценки: through study completion, an average of 9 months]
• Area under the plasma concentration versus time curve (AUC) of desethyloxybutynin (metabolite) in treated boys over treatment [Срок оценки: through study completion, an average of 9 months]
• Peak Plasma Concentration (Cmax) of desethyloxybutynin (metabolite) in treated boys over treatment [Срок оценки: through study completion, an average of 9 months]
• Minimum plasma concentration (Cmin) of desethyloxybutynin (metabolite) in treated boys over treatment [Срок оценки: through study completion, an average of 9 months]