A Phase 3 interventional study of Oxybutynin Hydrochloride and Placebo in Spina Bifida, sponsored by Central Hospital, Nancy, France. Recruiting at 19 sites in France. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Central Hospital, Nancy, France · Phase 3, Interventional, and Treatment
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. It is responsible for renal failure requiring dialysis and transplantation. Current therapeutics aim to evacuate urine and reduce intravesical pressure. It gradually combines 1) intermittent catheterization, 2) anticholinergics, 3) botulinum toxin (Botox®) injection into the detrusor (bladder muscle) by cystoscopy and 4) surgery (vesicostomy, Bricker, enterocystoplasty). Oxybutynin relaxes the detrusor, improves continence and reduces intravesical pressure. It is usually administered per os, but there are contraindications (glaucoma, myasthenia), side effects (constipation, dry mouth). It can be difficult to swallow for children, and drug resistance may develop. It can lead to ineffective treatment requiring therapeutic escalation. The next step, intradetrusor Botox® injection, is invasive (cystoscopy), has a limited duration of action (6 months) and must be performed under general anesthesia in children.
Surgical treatments are effective but irreversible and responsible for morbidity and mortality. A randomized study was performed demonstrating the efficacy of intravesical oxybutynin compared to oral administration in adult patients. This study found a significant increase in bladder capacity and a significant decrease in side effects in the intravesical oxybutynin group. Due to the relative difficulties of intravesical oxybutynin delivery (preparation, cost) and the more invasive nature, it is not used as an alternative to oral oxybutynin.
The hypothesis of this study is that this treatment may have a legitimate place in the treatment of neurogenic bladder in patients with failure of anticholinergic treatment before a therapeutic escalation requiring an invasive procedure (Botox®, enterocystoplasty) especially in children for whom repeated general anesthesia for Botox® injection may interfere with brain development. In this way, the investigators aim to extend the time to therapeutic escalation in the pediatric population.
The main objective of the trial is to 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.
Secondary objectives of the trial :
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This study's planned enrollment of 60 is above the median of 30 across 91 interventional studies indexed under Spinal Dysraphism.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Instillation of oxybutynin conditioned in VESOXX® 10mg/10mL ready-to-use syringes (1mg/mL) at the end of the evacuation catheterization. Dose: 0.4mg/kg/day in 2 to 3 instillations per day, i.e. a maximum of 10mg per instillation. Maximum dose: 20mg/day for patients aged 6-11 years and 11 months, and 30mg/day for patients aged 12-17 years.
Drug: Oxybutynin Hydrochloride
Instillation of saline solution conditioned in 10 mL ready-to-use syringes at the end of the evacuation catheterization. Dose equivalent to IVO in ml, i.e. always 0.4mg/kg/day, i.e. a maximum of 10 mL per instillation. Maximum dose: 20mL/day for patients aged 6-11 years and 11 months, and 30mL/day for patients aged 12 to 17 years.
Drug: Placebo
Pharmaceutical form: solution. Route of administration: Intravesical. Medicinal product unique ID: PRD8074745. EU active substance code: SUB03581MIG.
Pharmaceutical form: solution. Route of administration: Intravesical.
Also known as: Sterile 0.9% NaCl solution for intravesical instillation
Evolution of maximal bladder capacity at 4 weeks of treatment (end of follow-up)
This parameter is considered by experts to be an objective marker of improvement in neurological bladder, in addition to the secondary clinical objective. It was used as the primary objective in the only prospective study in the literature. It is obtained by cystomanometry and is defined by the maximum volume (in mL) measured at the moment when permission to urinate is given to the patient, after filling via urethral catheter. In younger patients, urination occurs spontaneously, and this value is obtained a posteriori by curve analysis. If treatment is successful, maximum bladder capacity should increase.
Time frame: 4 weeks
Evolution of maximal bladder pressure at 4 weeks of treatment (end of follow-up)
This parameter is considered by experts to be an objective marker of neurological bladder improvement, in addition to the primary objective. This data is obtained during cystomanometry. If treatment is effective, it should decrease.
Time frame: 4 weeks
Urinary incontinence
Time to clinical treatment failure defined by criteria found in literature and marketing authorization of Botox® in a 28-day time frame (at least one of the 3 criteria): * Treatment judged as non-effective by either the patient or the practitioner; * Reduction of urinary incontinence to less than 50% of the initial occurrences measured in the initial bladder diary; * Intolerable side effects reported by the patient.
Time frame: 4 weeks
Evaluation of the number of side effects
Side effects are recorded by the patient in a treatment follow-up booklet or by the practitioner during follow-up. They include digestive, psychiatric, neurological, cutaneous and urological disorders, pain associated with instillation of the product, and other effects.
Time frame: 4 weeks
Proportion of responders at 4 weeks of treatment
This corresponds to patients who achieved at least a 50% reduction in urinary incontinence episodes after 4 weeks of treatment, with no intolerable side effects (leading to discontinuation of treatment) at the end of the study. The number of incontinence episodes are collected over 72 consecutive hours in the week preceding each visit (V1, V2 and V3) by the patient on a bladder diary. Side effects are recorded by the patient in the treatment follow-up booklet and by the practitioner at each visit.
Time frame: 4 weeks
Proportion of continent patients at 4 weeks of treatment
It corresponds to patients who had a 100% reduction in urinary incontinence episodes by the end of the study. This group is part of the responder group at 4 weeks of treatment.
Time frame: 4 weeks
Product usability measured with usability questionnaire
Ease of use, which improves patient acceptability and compliance, is measured using the short version of the Usability Metric for User Experience scale (UMUX-LITE) containing two positive items with a 7-point response scale, coupled with six ad hoc questions specific to the treatment and the disease. The values of each question range from 0 (totally disagree) to 7 (totally agree).
Time frame: 4 weeks
Standardized difference in patient quality of life calculated according to the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF) score between the beginning and the end of the study.
It is calculated on the basis of changes in the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF) questionnaire score between the start and end of the patient's participation in the study. The answers to the 3 items of the questionnaire result in a sum, with minimum score of 0 ("no incontinence"), and maximum score of 21 ("maximum urinary incontinence").
Time frame: 4 weeks
Standardized difference in patient quality of life calculated according to the KIDSCREEN-10 score between the beginning and the end of the study.
It is calculated on the basis of changes in the KIDSCREEN-10 Index between the start and end of the patient's participation in the study. The KIDSCREEN-10 Index, developed by the project "Screening For and Promotion of Health-Related Quality of Life in Children and Adolescents - a European Public Health perspective", contains 10 items. The sum score is comprised between 10 and 50, where 10 represents the lowest possible value and thus a very low health-related quality of life and 50 the maximum value, i.e. a very high health-related quality of life.
Time frame: 4 weeks
Evolution of the number of urinary catheterizations at 4 weeks of treatment
This evolution is assessed by comparing the number of urinary catheterizations over 72 hours during the week preceding each visit (V1, V2 and V3).
Time frame: 4 weeks
Evolution of the volume of urinary catheterizations at 4 weeks of treatment
This evolution is assessed by comparing the volume of urinary catheterizations over 72 hours during the week preceding each visit (V1, V2 and V3).
Time frame: 4 weeks
Evolution of the bladder compliance at 4 weeks of treatment
The bladder compliance (mL/cmH2O) is measured 2 times using cystomanometry : prior to treatment and at the end of treatment. The 2 values obtained are compared.
Time frame: 4 weeks
Evolution of the minimum filling volume causing uninhibited detrusor contraction at 4 weeks of treatment
The minimum filling volume causing uninhibited detrusor contraction (mL) is measured 2 times using cystomanometry : prior to treatment and at the end of treatment. The 2 values obtained are compared.
Time frame: 4 weeks
Evolution of the Detrusor leak point pressure at 4 weeks of treatment
The Detrusor leak point pressure (cmH2O) is measured 2 times using cystomanometry : prior to treatment and at the end of treatment. The 2 values obtained are compared.
Time frame: 4 weeks
Evolution of the volume of bladder filling during urine loss at 4 weeks of treatment
The volume of bladder filling during urine loss (mL) is measured 2 times using cystomanometry : prior to treatment and at the end of treatment. The 2 values obtained are compared.
Time frame: 4 weeks
Evolution of renal ultrasonography at 4 weeks of treatment
Renal ultrasonography performed at the end of treatment is compared with the renal ultrasonography performed prior to treatment. This enables an assessment of the impact on the upper urinary tract, and is an indirect marker of bladder condition. The standard parameters assessed are : * Anteroposterior diameter of the pyelo (mm); * Ureter diameter (mm)
Time frame: 4 weeks
Plan to share: No
Started Jan 2026 (actual). Primary completion is estimated for Jan 2028, 24 months after the start.
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Studies of the drug tested here: Oxybutynin
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