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Efficacy of Intravesical Oxybutynin in Children With Neurogenic Bladder Dysfunction
Sponsor: Central Hospital, Nancy, France
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 contraindications (glaucoma, myasthenia), side effects (constipation, dry mouth). It can be difficult to swallow for children, and drug resistance may develop. It can lead to ineffective treatment requiring therapeutic escalation. The next step, intradetrusor Botox® injection, is invasive (cystoscopy), has a limited duration of action (6 months) and must be performed under general anesthesia in children. Surgical treatments are effective but irreversible and responsible for morbidity and mortality. A randomized study was performed demonstrating the efficacy of intravesical oxybutynin compared to oral administration in adult patients. This study found a significant increase in bladder capacity and a significant decrease in side effects in the intravesical oxybutynin group. Due to the relative difficulties of intravesical oxybutynin delivery (preparation, cost) and the more invasive nature, it is not used as an alternative to oral oxybutynin. Our hypothesis is that this treatment may have a legitimate place in the treatment of neurogenic bladder in patients with failure of anticholinergic treatment before a therapeutic escalation requiring an invasive procedure (Botox®, enterocystoplasty) especially in children for whom repeated general anesthesia for Botox® injection may interfere with brain development. In this way, we aim to extend the time to therapeutic escalation in the pediatric population. The main objective of the trial is to compare the efficacy on maximal bladder capacity of intravesical oxybutynin instillation versus placebo in the treatment of children with overactive neurogenic bladder (spina bifida), performing intermittent catheterization, for whom oral anticholinergic treatment is ineffective or poorly tolerated.
Official title: Efficacy of Intravesical Oxybutynin in Children With Neurogenic Bladder Dysfunction: A Randomized, Prospective Controlled Multi-center Trial
Key Details
Gender
All
Age Range
6 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-09
Completion Date
2027-10
Last Updated
2025-06-18
Healthy Volunteers
No
Conditions
Interventions
Oxybutynin Hydrochloride
Pharmaceutical form: solution. Route of administration: Intravesical. Medicinal product unique ID: PRD8074745. EU active substance code: SUB03581MIG.
Placebo
Pharmaceutical form: solution. Route of administration: Intravesical.
Locations (19)
Centre Hospitalier Universitaire de Besançon
Besançon, France
Centre Hospitalier Universitaire De Bordeaux
Bordeaux, France
Centre Hospitalier Régional Et Universitaire De Brest
Brest, France
Centre Hospitalier Universitaire De Caen Normandie
Caen, France
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, France
Centre Hospitalier De Colmar
Colmar, France
Centre Hospitalier Universitaire Grenoble Alpes
Grenoble, France
Centre Hospitalier Universitaire de Lille
Lille, France
Centre Hospitalier Et Universitaire De Limoges
Limoges, France
Centre Hospitalier Régional De Marseille
Marseille, France
Fondation Lenval Nice
Nice, France
Hôpital Necker Enfants Malades
Paris, France
Hôpital Trousseau (chirurgie viscérale pédiatrique et néonatale)
Paris, France
Hôpital Trousseau (médecine physique et de réadaptation pédiatrique)
Paris, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, France
Centre Hospitalier Universitaire de Rennes
Rennes, France
Centre Hospitalier Universitaire De Saint Etienne
Saint-Etienne, France
Les Hopitaux Universitaires De Strasbourg
Strasbourg, France
Centre Hospitalier Régional Et Universitaire de Nancy
Vandœuvre-lès-Nancy, France