Evidence map›Paper›PMID 41178302›Full record

ArticleBJU international2026

Intravesical oxybutynin for bladder capacity in children with spina bifida: the 'Place de l'OXybutynine Intravésicale chez le Patient Enfant Neurologique' (POXIPEN) trial protocol.

Marie Buzzi, Jonathan Epstein, Zahi Hatem, Nadine Juge, Charles Mazeaud, Jean-Louis Lemelle, Nicolas Berte

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BJU international, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07027020 (Efficacy of Intravesical Oxybutynin in Children With Neurogenic Bladder Dysfunction), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07027020 phase3recruitingnot on this map

Efficacy of Intravesical Oxybutynin in Children With Neurogenic Bladder Dysfunction: A Randomized, Prospective Controlled Multi-center Trial

TypeinterventionalSponsorCentral Hospital, Nancy, FranceRan2026 to 2028Enrolled60ConditionsSpina BifidaArmsOxybutynin Hydrochloride, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Marie BuzziCHRU-Nancy, INSERM, CIC, Epidémiologie Clinique, Université de Lorraine, Nancy, France.ORCID 0000-0003-3002-6976
Jonathan EpsteinCHRU-Nancy, INSERM, CIC, Epidémiologie Clinique, Université de Lorraine, Nancy, France.
Zahi HatemCHRU-Nancy, Pediatric Surgery Department, Université de Lorraine, Nancy, France.
Nadine JugeCHRU-Nancy, INSERM, CIC, Epidémiologie Clinique, Université de Lorraine, Nancy, France.
Charles MazeaudCHRU-Nancy, Urology Department, Université de Lorraine, Nancy, France.
Jean-Louis LemelleCHRU-Nancy, Pediatric Surgery Department, Université de Lorraine, Nancy, France.
Nicolas BerteCHRU-Nancy, Pediatric Surgery Department, Université de Lorraine, Nancy, France.

Funding

Association Nationale Spina Bifida HandicapsFarco PharmaFrench Ministry of Health PHRC-N-2021
6 · The paper itself

Abstract

backgroundNeurogenic bladder is defined as a dysfunction of the bladder resulting from damage to the central or peripheral nervous systems. Its treatment is based on a progressive therapeutic escalation, rapidly involving invasive therapeutic procedures such as repeated intradetrusor injections and surgery. Given the risk of repeated general anaesthesia in children, there is a need for non-invasive treatment for young patients who do not respond to or have adverse effects from oral anticholinergic treatment. The 'Place de l'OXybutynine Intravésicale chez le Patient Enfant Neurologique' (POXIPEN) trial aims to assess the efficacy of intra-vesical oxybutynin on bladder capacity in a sample of French children with neurogenic bladder. STUDY

designThe POXIPEN is a multicentre, randomised, double-blind, placebo-controlled trial. ENDPOINTS: The primary outcome is change in maximal bladder capacity after treatment. Secondary outcomes include changes in voiding, urodynamic and ultrasound parameters. We will also assess changes on quality of life and usability of the product. PATIENTS AND

methodsWe aim to randomly assign 60 children with neurogenic bladder secondary to spina bifida and deemed non-responders to first-line treatment with oral anticholinergics, to receive intravesical oxybutynin (IVO) or placebo for 4 weeks. Recruitment will start in September 2025. It will be the first prospective study to evaluate the efficacy of IVO in children, with a high level of evidence provided by its design. If IVO proves effective, it could lengthen the delay in therapeutic escalation to invasive procedures, thereby reducing the risk of complications associated with general anaesthesia in children with neurogenic bladder.

trial registrationThis trial is registered with the European Union (EU) Clinical Trials Information System (CTIS) under EU CT Number: 2022-501 902-36-00 (approved 09.01.2025) and ClinicalTrials.gov under identifier NCT07027020 (registered 18.06.2025).

Indexed as

Mandelic AcidsMuscarinic AntagonistsSpinal DysraphismUrinary Bladder, NeurogenicAdministration, IntravesicalAdolescentChildChild, PreschoolClinical Trials, Phase III as TopicDouble-Blind MethodFemaleHumansMaleMulticenter Studies as TopicRandomized Controlled Trials as TopicTreatment OutcomeMandelic AcidsMuscarinic Antagonistsoxybutyninneurogenic bladderpaediatric surgeryrandomised controlled trialspina bifidaurology

Identifiers

PMID41178302
PMCPMC12789847

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.