Spina BifidaPhase 3POXIPENNCT07027020
Efficacy of Intravesical Oxybutynin in Children With Neurogenic Bladder Dysfunction
A Phase 3 study testing Oxybutynin Hydrochloride in people with Spina Bifida, run by Central Hospital, Nancy, France at 19 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Spina Bifida
- What is being tested?
- Oxybutynin Hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 19 sitesFrance
- Study dates
- 15 Jan 2026to Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
France19 sites, 19 recruiting
- Not yet recruiting
Centre Hospitalier Universitaire de Besançon
Besançon
- Not yet recruiting
Centre Hospitalier Universitaire De Bordeaux
Bordeaux
- Not yet recruiting
Centre Hospitalier Régional Et Universitaire De Brest
Brest
- Not yet recruiting
Centre Hospitalier Universitaire De Caen Normandie
Caen
- Not yet recruiting
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand
- Not yet recruiting
Centre Hospitalier De Colmar
Colmar
- Not yet recruiting
Centre Hospitalier Universitaire Grenoble Alpes
Grenoble
- Not yet recruiting
Centre Hospitalier Universitaire de Lille
Lille
- Not yet recruiting
Centre Hospitalier Et Universitaire De Limoges
Limoges
- Not yet recruiting
Centre Hospitalier Régional De Marseille
Marseille
- Not yet recruiting
Fondation Lenval Nice
Nice
- Not yet recruiting
Hôpital Necker Enfants Malades
Paris
- Not yet recruiting
Hôpital Trousseau (chirurgie viscérale pédiatrique et néonatale)
Paris
- Not yet recruiting
Hôpital Trousseau (médecine physique et de réadaptation pédiatrique)
Paris
- Not yet recruiting
Centre Hospitalier Universitaire de Poitiers
Poitiers
- Not yet recruiting
Centre Hospitalier Universitaire de Rennes
Rennes
- Not yet recruiting
Centre Hospitalier Universitaire De Saint Etienne
Saint-Etienne
- Not yet recruiting
Les Hopitaux Universitaires De Strasbourg
Strasbourg
- Recruiting
Centre Hospitalier Régional Et Universitaire de Nancy
Vandœuvre-lès-Nancy
About this study
Official title: Efficacy of Intravesical Oxybutynin in Children With Neurogenic Bladder Dysfunction: A Randomized, Prospective Controlled Multi-center Trial
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.
Read more
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.
Read the detailed description
Secondary objectives of the trial :
- Secondary efficacy objectives will be analyzed following a fixed sequence in a priori ordered hypotheses: to evaluate after treatment with intravesical oxybutynin (IVO) or placebo instillation: maximum bladder pressure evolution; incontinence: time to clinical treatment failure perceived by the patient. These parameters are considered by experts to be objective markers of neurological bladder improvement, in addition to the primary urodynamic objective.
- Evaluate and compare between groups the tolerance and adverse effects of treatment.
- Evaluate and compare between groups the number of responders and continent patients after treatment
- Evaluate and compare between groups the usability of Intravesical Oxybutynin.
- Evaluate and compare between groups the evolution of quality of life.
- Evaluate and compare between groups the evolution of bladder diary data.
- Evaluate and compare between groups the evolution of other urodynamic parameters.
- Evaluate and compare between groups the evolution of renal ultrasonography parameters.
- Identify factors, among the patient's characteristics, associated with a greater probability to be a responder or non-responder to intravesical oxybutynin
- Conditions
- Spina Bifida
- Being tested
- Oxybutynin Hydrochloride, Placebo
- Keywords
- Intravesical Oxybutynin, overactive neurogenic bladder, intermittent catheterization, Oxybutynin, anticholinergic, Pediatric patients
- Medical subject headings
- Spinal Dysraphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxybutynin HydrochlorideDrug
Pharmaceutical form: solution. Route of administration: Intravesical. Medicinal product unique ID: PRD8074745. EU active substance code: SUB03581MIG.
PlaceboDrug
Also called Sterile 0.9% NaCl solution for intravesical instillation
Pharmaceutical form: solution. Route of administration: Intravesical.
| Study group | Role | What they receive |
|---|---|---|
| IntraVesical Oxybutynin (IVO) | Experimental | 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. Receives: Drug: Oxybutynin Hydrochloride |
| IntraVesical Placebo (PCB) | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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").
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start15 Jan 2026
- Primary completionJan 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spina BifidaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, FARCO PHARMA
- Responsible party
- Principal investigator, Nicolas BERTE, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027020
- Sponsor's protocol ID
- 2019PI119
- Other IDs
- 2022-501902-36-00
- Acronym
- POXIPEN
- Status last verified
- Jan 2026
- First submitted
- 22 May 2025
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buzzi M, Epstein J, Hatem Z, Juge N, Mazeaud C, Lemelle JL, Berte N. Intravesical oxybutynin for bladder capacity in children with spina bifida: the 'Place de l'OXybutynine Intravesicale chez le Patient Enfant Neurologique' (POXIPEN) trial protocol. BJU Int. 2026 Feb;137(2):390-398. doi: 10.1111/bju.70058. Epub 2025 Nov 3.
PubMed 41178302
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intravesical Oxybutynin in Children With Neurogenic Bladder Dysfunction: A Randomized, Prospective Controlled Multi-center Trial
- ClinicalTrials.gov ID
- NCT07027020
- Acronym / sponsor ID
- POXIPEN / 2019PI119
- Conditions
- Spina Bifida
- Keywords
- Intravesical Oxybutynin, overactive neurogenic bladder, intermittent catheterization, Oxybutynin, anticholinergic, Pediatric patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Ministry of Health, France, FARCO PHARMA
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Secondary objectives of the trial :
- Secondary efficacy objectives will be analyzed following a fixed sequence in a priori ordered hypotheses: to evaluate after treatment with intravesical oxybutynin (IVO) or placebo instillation: maximum bladder pressure evolution; incontinence: time to clinical treatment failure perceived by the patient. These parameters are considered by experts to be objective markers of neurological bladder improvement, in addition to the primary urodynamic objective.
- Evaluate and compare between groups the tolerance and adverse effects of treatment.
- Evaluate and compare between groups the number of responders and continent patients after treatment
- Evaluate and compare between groups the usability of Intravesical Oxybutynin.
- Evaluate and compare between groups the evolution of quality of life.
- Evaluate and compare between groups the evolution of bladder diary data.
- Evaluate and compare between groups the evolution of other urodynamic parameters.
- Evaluate and compare between groups the evolution of renal ultrasonography parameters.
- Identify factors, among the patient's characteristics, associated with a greater probability to be a responder or non-responder to intravesical oxybutynin
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IntraVesical Oxybutynin (IVO) | Experimental | Drug: Oxybutynin HydrochlorideInstillation 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. |
| IntraVesical Placebo (PCB) | Placebo comparator | Drug: PlaceboInstillation 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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxybutynin HydrochloridePharmaceutical form: solution. Route of administration: Intravesical. Medicinal product unique ID: PRD8074745. EU active substance code: SUB03581MIG. | Drug | IntraVesical Oxybutynin (IVO) |
| PlaceboAlso: Sterile 0.9% NaCl solution for intravesical instillationPharmaceutical form: solution. Route of administration: Intravesical. | Drug | IntraVesical Placebo (PCB) |
Primary outcome
Evolution of maximal bladder capacity at 4 weeks of treatment (end of follow-up)
Time frame: 4 weeks
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.
15 secondary outcomes
Evolution of maximal bladder pressure at 4 weeks of treatment (end of follow-up)
Time frame: 4 weeks
Urinary incontinence
Time frame: 4 weeks
Evaluation of the number of side effects
Time frame: 4 weeks
Proportion of responders at 4 weeks of treatment
Time frame: 4 weeks
Proportion of continent patients at 4 weeks of treatment
Time frame: 4 weeks
Product usability measured with usability questionnaire
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.
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.
Time frame: 4 weeks
Evolution of the number of urinary catheterizations at 4 weeks of treatment
Time frame: 4 weeks
Evolution of the volume of urinary catheterizations at 4 weeks of treatment
Time frame: 4 weeks
Evolution of the bladder compliance at 4 weeks of treatment
Time frame: 4 weeks
Evolution of the minimum filling volume causing uninhibited detrusor contraction at 4 weeks of treatment
Time frame: 4 weeks
Evolution of the Detrusor leak point pressure at 4 weeks of treatment
Time frame: 4 weeks
Evolution of the volume of bladder filling during urine loss at 4 weeks of treatment
Time frame: 4 weeks
Evolution of renal ultrasonography at 4 weeks of treatment
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Derived from this study: PubMed 41178302Buzzi M, Epstein J, Hatem Z, Juge N, Mazeaud C, Lemelle JL, Berte N. Intravesical oxybutynin for bladder capacity in children with spina bifida: the 'Place de l'OXybutynine Intravesicale chez le Patient Enfant Neurologique' (POXIPEN) trial protocol. BJU Int. 2026 Feb;137(2):390-398. doi: 10.1111/bju.70058. Epub 2025 Nov 3.
- Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxybutynin Hydrochloride in people with Spina Bifida, run by Central Hospital, Nancy, France at 19 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas BERTE, Dr (0383155287 ext. +33, n.berte@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of maximal bladder capacity at 4 weeks of treatment (end of follow-up) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07027020, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.