Evidence map›Paper›PMID 33305474›Full record

Trial reportNeurourology and urodynamics2021

OnabotulinumtoxinA for the treatment of neurogenic detrusor overactivity in children.

Paul F Austin, Israel Franco, Eric Dobremez, Pawel Kroll, Wilson Titanji, Till Geib, Brenda Jenkins, Piet B Hoebeke

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Neurourology and urodynamics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
3.9field-weighted citation impact, top 6% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 38 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 3 countries.

Paul F AustinTexas Children's Hospital, Baylor College of Medicine, Houston, Texas, USA.ORCID 0000-0003-3654-9524
Israel FrancoYale New Haven Children's Hospital, New Haven, Connecticut, USA.ORCID 0000-0002-5675-873X
Eric DobremezHôpital Pellegrin Enfants, Bordeaux, France.
Pawel KrollNeuro-urology Unit, Paediatric Urology Clinic, Poznań, Poland.
Wilson TitanjiAllergan, an AbbVie company, Irvine, California, USA.
Till GeibAllergan, an AbbVie company, Irvine, California, USA.
Brenda JenkinsAllergan, an AbbVie company, Irvine, California, USA.
Piet B HoebekeGhent University Hospital, Ghent, Belgium.
AbbVie (United States) · USBaylor College of Medicine · USGhent University Hospital · BEHôpital Pellegrin · FRYale New Haven Hospital · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

aimsThis study evaluated whether one (or more) of three doses of onabotulinumtoxinA were safe and effective to treat neurogenic detrusor overactivity (NDO) in children.

methodsThis was a 48-week prospective, multicenter, randomized, double-blind study in children (aged 5-17 years) with NDO and urinary incontinence (UI) receiving one onabotulinumtoxinA treatment (50, 100, or 200 U; not to exceed 6 U/kg). Primary endpoint: change from baseline in daytime UI episodes. Secondary endpoints: change from baseline in urine volume at first morning catheterization, urodynamic measures, and positive response on the treatment benefit scale. Safety was also assessed.

resultsThere was a similar reduction in urinary incontinence from baseline to Week 6 for all doses (-1.3 episodes/day). Most patients reported positive responses on the treatment benefit scale (75.0%-80.5%). From baseline to Week 6, increases were observed in urine volume at first morning clean intermittent catheterization (50 U, 21.9 ml; 100 U, 34.9 ml; 200 U, 87.5 ml; p = 0.0055, 200 U vs. 50 U) and in maximum cystometric capacity (range 48.6-63.6 ml) and decreases in maximum detrusor pressure during the storage phase (50 U, -12.9; 100 U, -20.1; 200 U, -27.3 cmH

conclusionsOnabotulinumtoxinA was well tolerated and effective for the treatment of NDO in children; 200 U showed greater efficacy in reducing bladder pressure and increasing bladder capacity.

Indexed as

AdolescentBotulinum Toxins, Type AChildChild, PreschoolDouble-Blind MethodFemaleHumansMaleProspective StudiesTreatment OutcomeUrinary Bladder, NeurogenicBotulinum Toxins, Type Aonabotulinum toxin Abotulinum toxinsneurogenicpediatricsType Aurinary bladder

Identifiers

PMID33305474
PMCPMC7839517
OpenAlexW3112576118

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.