Efficacy of Intravesical Oxybutynin in Children With Neurogenic Bladder Dysfunction: A Randomized, Prospective Controlled Multi-center Trial

What this Trial Is About

Neurogenic bladder dysfunction caused by spina bifida affects bladder control in children, leading to problems such as small bladder capacity, overactivity, incontinence, and urine evacuation issues. These complications can result in kidney failure requiring dialysis or transplantation. Current treatments include intermittent catheterization, oral anticholinergic medications like oxybutynin, botulinum toxin injections, and surgery. Oral oxybutynin can cause side effects and may be difficult for children to take, while invasive treatments like botulinum toxin injection require general anesthesia, which may affect brain development in children. This trial compares the effects of intravesical oxybutynin instillation—where the medication is delivered directly into the bladder—versus a placebo in children aged 6 to 17 years with overactive neurogenic bladder due to spina bifida who have not responded well or tolerated oral anticholinergics. Participants receive doses based on their weight, administered 2 to 3 times daily via catheterization. The study is randomized and triple-blinded, with one group receiving oxybutynin solution and the other a saline placebo. Participants are monitored over 4 weeks to assess bladder capacity and pressure, urinary incontinence, side effects, treatment usability, quality of life, and kidney ultrasound results. Assessments include bladder diary data, urodynamic tests, questionnaires, and physical exams. The study aims to delay the need for more invasive treatments in children while evaluating the safety and tolerability of intravesical oxybutynin. The total participation period is 4 weeks, with close follow-up during this time.

Efficacy of Intravesical Oxybutynin in Children With Neurogenic Bladder Dysfunction