urethral posterior valve
Conditions
Brief summary
Composite endpoint where the success of treatment at 9 months after treatment inclusion is defined by the association of the three following events: - Bladder compliance >10mL/cmH2O AND - Voiding pressure <60 cmH2O AND - Bladder Volume ≥70% of theoretical value
Detailed description
Proportion and type of adverse events in each group, Incidence of urinary tract infections in each group, Compliance with treatment will be evaluated through the proportion of oxybutynin treatment interruption, Sonographic changes will be expressed as a degree of hydronephrosis at 12-15 months of life (9 months after inclusion), AUC, Cmax, Cmin and half-life of oxybutynin and desethyloxybutynin (active metabolite) in treated boys over treatment. Pharmacokinetic samples (6 points from Cmin to H+3h) at 2 weeks, 3 and 9 months after inclusion will be used to study and determine the pharmacokinetic parameters. In order to avoid having to take blood sample from the child several times, it is proposed to use a small venous catheter during the time of the pharmacokinetic samples., Creatinine clearance in each group
Interventions
DRUGPMS-Oxybutynin
Sponsors
Centre Hospitalier Universitaire De Bordeaux
Eligibility
Sex/Gender
Male
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite endpoint where the success of treatment at 9 months after treatment inclusion is defined by the association of the three following events: - Bladder compliance >10mL/cmH2O AND - Voiding pressure <60 cmH2O AND - Bladder Volume ≥70% of theoretical value | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion and type of adverse events in each group, Incidence of urinary tract infections in each group, Compliance with treatment will be evaluated through the proportion of oxybutynin treatment interruption, Sonographic changes will be expressed as a degree of hydronephrosis at 12-15 months of life (9 months after inclusion), AUC, Cmax, Cmin and half-life of oxybutynin and desethyloxybutynin (active metabolite) in treated boys over treatment. Pharmacokinetic samples (6 points from Cmin to H+3h) at 2 weeks, 3 and 9 months after inclusion will be used to study and determine the pharmacokinetic parameters. In order to avoid having to take blood sample from the child several times, it is proposed to use a small venous catheter during the time of the pharmacokinetic samples., Creatinine clearance in each group | — |
Countries
France
Outcome results
None listed