Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-25 @ 4:15 AM
NCT ID:
NCT07027020
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT07027020
Study Brief:
Protocol Section:
NCT07027020