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New hope for kids with spina bifida: bladder drug delivered directly may delay surgery

NCT ID NCT07027020

Disease control Sponsor: Central Hospital, Nancy, France Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving oxybutynin directly into the bladder (instead of by mouth) can increase bladder capacity and reduce the need for more invasive treatments like Botox injections or surgery in children with spina bifida. About 60 children whose current oral medication is not working or causes side effects will receive either the bladder-instilled drug or a placebo for 4 weeks. The goal is to see if this approach can safely improve bladder function and delay more aggressive procedures.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

spina bifida

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Spina bifida

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    19 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre Hospitalier De Colmar

    NOT_YET_RECRUITING

    Colmar, France

  • Centre Hospitalier Et Universitaire De Limoges

    NOT_YET_RECRUITING

    Limoges, France

  • Centre Hospitalier Régional De Marseille

    NOT_YET_RECRUITING

    Marseille, France

  • Centre Hospitalier Régional Et Universitaire De Brest

    NOT_YET_RECRUITING

    Brest, France

  • Centre Hospitalier Régional Et Universitaire de Nancy

    RECRUITING

    Vandœuvre-lès-Nancy, France

  • Centre Hospitalier Universitaire De Bordeaux

    NOT_YET_RECRUITING

    Bordeaux, France

  • Centre Hospitalier Universitaire De Caen Normandie

    NOT_YET_RECRUITING

    Caen, France

  • Centre Hospitalier Universitaire De Saint Etienne

    NOT_YET_RECRUITING

    Saint-Etienne, France

  • Centre Hospitalier Universitaire Grenoble Alpes

    NOT_YET_RECRUITING

    Grenoble, France

  • Centre Hospitalier Universitaire de Besançon

    NOT_YET_RECRUITING

    Besançon, France

  • Centre Hospitalier Universitaire de Clermont-Ferrand

    NOT_YET_RECRUITING

    Clermont-Ferrand, France

  • Centre Hospitalier Universitaire de Lille

    NOT_YET_RECRUITING

    Lille, France

  • Centre Hospitalier Universitaire de Poitiers

    NOT_YET_RECRUITING

    Poitiers, France

  • Centre Hospitalier Universitaire de Rennes

    NOT_YET_RECRUITING

    Rennes, France

  • Fondation Lenval Nice

    NOT_YET_RECRUITING

    Nice, France

  • Hôpital Necker Enfants Malades

    NOT_YET_RECRUITING

    Paris, France

  • Hôpital Trousseau (chirurgie viscérale pédiatrique et néonatale)

    NOT_YET_RECRUITING

    Paris, France

  • Hôpital Trousseau (médecine physique et de réadaptation pédiatrique)

    NOT_YET_RECRUITING

    Paris, France

  • Les Hopitaux Universitaires De Strasbourg

    NOT_YET_RECRUITING

    Strasbourg, France

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