OXYBUTYNIN for Posterior urethral valves

Inclusion criteria

• {"criterion_text":"- Boys aged 3 to 6 months"}
• {"criterion_text":"- Diagnosed with posterior urethral valves, and having undergone valve resection within the first 3 months of life"}
• {"criterion_text":"- Having undergone urodynamic studies between 10 weeks and 6 months of age and showing 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)/"}
• {"criterion_text":"- Affiliated person or beneficiary of a social security scheme."}
• {"criterion_text":"- Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research)."}

Exclusion criteria

• {"criterion_text":"- Boys with posterior urethral valves and normal urodynamics or no urodynamic assessment"}
• {"criterion_text":"- Boys requiring dialysis before the age of 3 months."}
• {"criterion_text":"- Boys who cannot undergo urodynamic testing for medical or anatomical reasons"}
• {"criterion_text":"- Boys with severe decreased gastrointestinal motility conditions"}
• {"criterion_text":"- Contra-indication to oxybutynin treatment such as hypersensitivity to oxybutynin ou 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"}

Primary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Success at 9 months after inclusion defined by meeting all three criteria: bladder compliance >10 mL/cmH2O, voiding pressure <60 cmH2O, and bladder volume ≥70% of theoretical value (measured by urodynamic studies/cystomanometry at 9 months)."}

Secondary endpoints

• {"endpoint_text":"- Proportion and type of adverse events in each group","definition_or_measurement_approach":"Adverse events collected and classified by type and proportion in each treatment group."}
• {"endpoint_text":"- Incidence of urinary tract infections in each group","definition_or_measurement_approach":"Incidence of urinary tract infections recorded for each group during follow-up."}
• {"endpoint_text":"- Compliance with treatment will be evaluated through the proportion of oxybutynin treatment interruption","definition_or_measurement_approach":"Treatment adherence assessed by proportion of participants interrupting oxybutynin."}
• {"endpoint_text":"- Sonographic changes will be expressed as a degree of hydronephrosis at 12-15 months of life (9 months after inclusion)","definition_or_measurement_approach":"Sonographic (ultrasound) assessment of hydronephrosis degree at 12-15 months of life (9 months post-inclusion)."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Pharmacokinetic sampling at 2 weeks, 3 months and 9 months with 6-point sampling from Cmin to H+3h to determine AUC, Cmax, Cmin and half-life for oxybutynin and desethyloxybutynin."}
• {"endpoint_text":"- Creatinine clearance in each group","definition_or_measurement_approach":"Renal function assessed by creatinine clearance in each treatment group."}

France

Earliest CTIS Part Ii Submission Date

16-09-2024

Latest Decision Or Authorization Date

08-04-2026

Processing Time Days

569

Number Of Sites

10

Number Of Participants

50

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Bordeaux

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France