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Intravesical oxybutynin for children with neurogenic bladder due to spina bifida

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

PHASE3 · Central Hospital, Nancy, France · NCT07027020

We will test whether oxybutynin placed directly into the bladder helps children aged 6–17 with overactive neurogenic bladder from spina bifida.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment60 (estimated)
Ages6 Years to 17 Years
SexAll
SponsorCentral Hospital, Nancy, France (other)
Locations19 sites (Besançon and 18 other locations)
Trial IDNCT07027020 on ClinicalTrials.gov

What this trial studies

This randomized, placebo-controlled Phase 3 trial compares intravesical oxybutynin instillations to placebo in children aged 6–17 with neurogenic overactive bladder due to spina bifida. Eligible participants have failed or cannot tolerate oral anticholinergics and typically perform intermittent catheterization. The primary outcome is urodynamic improvement, and secondary outcomes include maximum bladder pressure, time to clinical treatment failure for incontinence, adverse effects, number of responders, quality of life, bladder diary data, and renal ultrasound findings. The study will also evaluate usability of the intravesical route and identify patient factors linked to response.

Who should consider this trial

Good fit: Children aged 6–17 with spina bifida-related overactive neurogenic bladder who have recent urodynamic and renal ultrasound evaluations and who have insufficient response to or intolerance of oral anticholinergics are ideal candidates.

Not a fit: Children without neurogenic bladder, those outside the 6–17 age range, patients already well controlled on oral anticholinergics, or those with contraindications to intravesical therapy or active urinary infection are unlikely to benefit.

Why it matters

Potential benefit: If effective, intravesical oxybutynin could improve bladder capacity and continence while lowering bladder pressure, reducing the risk of kidney damage and the need for botulinum toxin injections or major surgery.

How similar studies have performed: Smaller case series and early trials have reported benefits of intravesical oxybutynin on bladder pressure and continence, but large randomized Phase 3 evidence has been limited to date.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Besançon and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Spina Bifida, Intravesical Oxybutynin, overactive neurogenic bladder, intermittent catheterization, Oxybutynin, anticholinergic, Pediatric patients

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.