Early Oxybutinin Treatment for Boys With Posterior Urethral Valves
ConditionMale Urogenital Diseases
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age3-6
SponsorUniversity Hospital, Bordeaux
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Oxybutynin 1 mg/ml Syrup
DrugThe 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
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Oxybutynin during 9 months.Experimental treatment 1 intervention
Group B: No oxybutyninNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
success of treatment defined by the association of the three events
composite endpoints where the success of treatment at 9 months after inclusion is defined by the association of the three following events: * Voiding pressure \<60 cmH2O AND * Bladder Volume ≥70% of theoretical value AND * for those without pop-off mechanisms, Bladder compliance \>10mL/cmH2O A failure of treatment will be defined as the absence of at least one of these events. In presence of a pressure pop-off mechanism, only voiding pressure and bladder volume will be analyzed.
Time frame
9 months after inclusionSecondary outcomes
1
Proportion of adverse events in each group
Time frame
through study completion, an average of 9 months2
Type of adverse events in each group
adverse event or serious adverse event
Time frame
through study completion, an average of 9 months3
Incidence of urinary tract infections in each group
Time frame
through study completion, an average of 9 months4
Compliance with treatment
Compliance with treatment will be evaluated through the proportion of oxybutynin treatment interruption
Time frame
9 months after inclusionSponsors and contacts
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Source ClinicalTrials.gov