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NOT YET RECRUITING
NCT07027020
PHASE3

Efficacy of Intravesical Oxybutynin in Children With Neurogenic Bladder Dysfunction

Sponsor: Central Hospital, Nancy, France

View on ClinicalTrials.gov

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

DRUG

Oxybutynin Hydrochloride

Pharmaceutical form: solution. Route of administration: Intravesical. Medicinal product unique ID: PRD8074745. EU active substance code: SUB03581MIG.

DRUG

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