Intravesical oxybutynin for children with neurogenic bladder due to spina bifida

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Centre Hospitalier Régional Et Universitaire de Nancy
  Vandœuvre-lès-Nancy, France Recruiting
• Centre Hospitalier Universitaire de Besançon
  Besançon, France Not yet recruiting
• Centre Hospitalier Universitaire De Bordeaux
  Bordeaux, France Not yet recruiting
• Centre Hospitalier Régional Et Universitaire De Brest
  Brest, France Not yet recruiting
• Centre Hospitalier Universitaire De Caen Normandie
  Caen, France Not yet recruiting
• Centre Hospitalier Universitaire de Clermont-Ferrand
  Clermont-Ferrand, France Not yet recruiting

Study contacts

• Study coordinator: Nicolas BERTE, Dr
• Email: n.berte@chru-nancy.fr
• Phone: 0383155287

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.