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Tests treatment safety and results for Spina Bifida
Official title Efficacy of Intravesical Oxybutynin in Children With Neurogenic Bladder Dysfunction
ClinicalTrials.gov ID: NCT07027020
What this study is testing
What is Oxybutynin Hydrochloride?
Oxybutynin Hydrochloride is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for spina bifida.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 17
You may be able to join if
- 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...
- 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...
- Age between 6 and 17 years old
You likely can't join if
- 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...
See the full eligibility 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...
- 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...
- 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).
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Besançon, France
- Bordeaux, France
- Brest, France
- Caen, France
- Clermont-Ferrand, France
- Colmar, France
- Grenoble, France
- Lille, France
- Limoges, France
- Marseille, France
- Nice, France
- Paris, France
- Poitiers, France
- Rennes, France
- Saint-Etienne, France
- Strasbourg, France
- Vandœuvre-lès-Nancy, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Besançon, France; Bordeaux, France; Brest, France; Caen, France; Clermont-Ferrand, France; Colmar, France and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.