BridgeMD
Efficacy of intravesical oxybutynin in children with neurogenic bladder dysfunction: A randomized, prospective controlled multi-center trial.
EU CTIS ID: 2022-501902-36-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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 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.
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 inhibitors.
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 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).
- 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 OR tubal ligation OR male partner with vasectomy).
- 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.
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, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.