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
Qualifiers
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
Treatments tested in this trial
- Oxybutynin 1 mg/ml Syrup
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov