Efficacy of Intravesical Oxybutynin in Children With Neurogenic Bladder Dysfunction
Malformation of the lumbosacral region (spina bifida) affects the innervation of the bladder in children. The usual evolution leads to a neurological bladder with small capacity, poor compliancy and overactivity, exposing to incontinence and obstruction to the evacuation of urine. It is responsible for renal failure re
| Condition(s) | Spina Bifida |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | Malformation of the lumbosacral region (spina bifida) affects the innervation of the bladder in children. The usual evolution leads to a neurological bladder with small capacity, poor compliancy and overactivity, exposing to incontinence and obstruction to the evacuation of urine. It is responsible for renal failure requiring dialysis and transplantation. Current therapeutics aim to evacuate urine and reduce intravesical pressure. It gradually combines 1) intermittent catheterization, 2) anticholinergics, 3) botulinum toxin (Botox®) injection into the detrusor (bladder muscle) by cystoscopy and 4) surgery (vesicostomy, Bricker, enterocystoplasty). Oxybutynin relaxes the detrusor, improves continence and reduces intravesical pressure. It is usually administered per os, but there are contrai |
| Who can participate | Inclusion Criteria: * Person affiliated to or beneficiary of a social security plan * In failure of treatment with one or more anticholinergics defined by a response considered insufficient by the investigator after at least 4 weeks of optimal dose treatment, unable to take oral oxybutynin or intolerable adverse events * Having performed renal ultrasonography less than 2 months ago * Having performed cystomanometry less than 6 months ago including maximal bladder capacity and maximal bladder pressure (preferably not under oral oxybutynin treatment) * Age between 6 and 17 years old * Informed about study organization, having given consent to participate and each legal representative have signed the informed consent * Having undergone the medical examination adapted to research * Presenting |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Lead sponsor | Central Hospital, Nancy, France |
| Locations | Besançon, France; Bordeaux, France; Brest, France; Caen, France; Clermont-Ferrand, France; Colmar, France (+13 more sites) |
| Start date | 2026-01-15 |
| NCT ID | NCT07027020 |
| Official listing | https://clinicaltrials.gov/study/NCT07027020 |