Efficacy of Intravesical Oxybutynin in Children With Neurogenic Bladder Dysfunction

Launched by CENTRAL HOSPITAL, NANCY, FRANCE · Jun 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat bladder problems in children with spina bifida, a condition that affects the nerves controlling the bladder. Many children with this condition have a small, overactive bladder that can cause accidents and damage the kidneys. Usually, they take medicine by mouth to relax the bladder, but this doesn’t always work well and can cause side effects like dry mouth or constipation. This study is testing whether putting the medicine oxybutynin directly into the bladder (instead of taking it by mouth) can help increase bladder size and reduce side effects, potentially delaying the need for more invasive treatments like Botox injections or surgery.

Children between 6 and 17 years old who have spina bifida and an overactive bladder that hasn’t improved enough with oral medicines may be eligible. Participants need to be doing regular catheterization to empty their bladder and be willing to have the medicine put directly into the bladder through a catheter. The study will compare the effects of intravesical (bladder) oxybutynin to a placebo to see if this method works better and is safer. This trial is not yet recruiting, but if eligible, families can expect careful medical follow-up and to learn whether this treatment might help manage bladder issues with fewer side effects, potentially avoiding more invasive procedures for a longer time.

Gender

ALL

Eligibility criteria

• 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 overactive bladder due to spina bifida confirmed by urodynamic check-up of less than 6 months. Overactive bladder is defined according to International Children's Continence Society, (ICCS): "a urodynamic observation characterized by involuntary detrusor contractions during the filling phase which may be spontaneous or provoked"
• • Carrying out intermittent catheterization for at least 6 weeks and at least three times a day
• • Able and volunteer to perform intravesical catheterization and instillation (patient or parents).
• Exclusion Criteria:
• • Person displaying known allergy to one of the components of evaluated product (notably oxybutynin).
• • Person with congestive cardiac failure
• • Person with cardiac arrhythmia
• • Person with tachycardia
• • Person with uncontrolled hypertension
• • Person under one of the following treatments : Bisphosphonates; Cytochrome P450 Inhibitors (such as ketoconazole and Erythromycin); Cholinesterase inhibitors.
• • Person displaying a contraindication to evaluated product, in particular: Hypersensitivity to oxybutynin; Myasthenia; Angle-closure glaucoma; Functional or organic gastrointestinal obstruction including pyloric stenosis, paralytic ileus and intestinal atony; Serious gastro-intestinal disorders (e.g., severe ulcerative colitis and toxic megacolon); Patients who have undergone ileostomy, colostomy, severe hemorrhagic colectasis or rectocolitis; Subvesical obstruction (urethral stenosis, posterior urethra valve); Ongoing treatment with anticholinergic drugs for another indication that could not be stopped; Patient with polyuria of other origin (renal, heart, potomania); Concomitant oxygenotherapy.
• • Woman of childbearing age without highly effective contraception (Sexual abstinence OR combined contraception by oral, intravaginal or transdermal ovulation inhibition OR progestin-only contraception by oral, injectable or implantable ovulation inhibition OR Intrauterine device or hormonal IUD).
• • Pregnant, parturient or breastfeeding woman.
• • Person deprived of liberty for judicial or administrative decision.
• • Person under psychiatric care as referred in articles L. 3212-1 and L. 3213-1.
• • Intradetrusor injection of botulinum toxin less than 6 months before.
• • Person with hyperthyroidism
• • Person with coronary cardiac disease.