Evidence map›Paper›PMID 30030330›Full record

Trial reportNeurology2018

Low-dose onabotulinumtoxinA improves urinary symptoms in noncatheterizing patients with MS.

Mark Tullman, Emmanuel Chartier-Kastler, Alfred Kohan, Veronique Keppenne, Benjamin M Brucker, Blair Egerdie, Meryl Mandle, Jean Paul Nicandro, Brenda Jenkins, Pierre Denys

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Neurology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01600716 (Safety and Efficacy Study of OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity), which is not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
1.4field-weighted citation impact, top 19% 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.

NCT01600716 phase3completednot on this map

Safety and Efficacy Study of OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity (NDO) in Non-Catheterizing Patients With Multiple Sclerosis (MS)

TypeinterventionalSponsorAllerganRan2012 to 2015Enrolled144ConditionsUrinary Incontinence, Multiple Sclerosis, Neurogenic BladderArmsOnabotulinumtoxinA, Placebo (Normal Saline)
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 22 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
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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

10 authors at 3 institutions in 1 country.

Mark TullmanFrom the MS Center for Innovations in Care (M.T.), St. Louis, MO; Sorbonne Universités (E.C.-K.), UPMC Paris 6, Pitié Salpétrière Academic Hospital, AP-HP, Paris, UMR Inserm 1179, France; Advanced Urology Centers (A.K.), Bethpage, NY; Université de Liège (V.K.), Belgium; New York University Langone Medical Center (B.M.B), New York; Urology Associates/Urologic Medical Research (B.E.), Kitchener, Ontario, Canada; Evidence Scientific Solutions (M.M.), Philadelphia, PA; Allergan plc (J.P.N., B.J.), Irvine, CA; and Hôpital Raymond Poincaré (P.D.), Garches, UVSQ, UMR Inserm 1179, France. mjt2796@bjc.org.
Emmanuel Chartier-KastlerFrom the MS Center for Innovations in Care (M.T.), St. Louis, MO; Sorbonne Universités (E.C.-K.), UPMC Paris 6, Pitié Salpétrière Academic Hospital, AP-HP, Paris, UMR Inserm 1179, France; Advanced Urology Centers (A.K.), Bethpage, NY; Université de Liège (V.K.), Belgium; New York University Langone Medical Center (B.M.B), New York; Urology Associates/Urologic Medical Research (B.E.), Kitchener, Ontario, Canada; Evidence Scientific Solutions (M.M.), Philadelphia, PA; Allergan plc (J.P.N., B.J.), Irvine, CA; and Hôpital Raymond Poincaré (P.D.), Garches, UVSQ, UMR Inserm 1179, France.
Alfred KohanFrom the MS Center for Innovations in Care (M.T.), St. Louis, MO; Sorbonne Universités (E.C.-K.), UPMC Paris 6, Pitié Salpétrière Academic Hospital, AP-HP, Paris, UMR Inserm 1179, France; Advanced Urology Centers (A.K.), Bethpage, NY; Université de Liège (V.K.), Belgium; New York University Langone Medical Center (B.M.B), New York; Urology Associates/Urologic Medical Research (B.E.), Kitchener, Ontario, Canada; Evidence Scientific Solutions (M.M.), Philadelphia, PA; Allergan plc (J.P.N., B.J.), Irvine, CA; and Hôpital Raymond Poincaré (P.D.), Garches, UVSQ, UMR Inserm 1179, France.
Veronique KeppenneFrom the MS Center for Innovations in Care (M.T.), St. Louis, MO; Sorbonne Universités (E.C.-K.), UPMC Paris 6, Pitié Salpétrière Academic Hospital, AP-HP, Paris, UMR Inserm 1179, France; Advanced Urology Centers (A.K.), Bethpage, NY; Université de Liège (V.K.), Belgium; New York University Langone Medical Center (B.M.B), New York; Urology Associates/Urologic Medical Research (B.E.), Kitchener, Ontario, Canada; Evidence Scientific Solutions (M.M.), Philadelphia, PA; Allergan plc (J.P.N., B.J.), Irvine, CA; and Hôpital Raymond Poincaré (P.D.), Garches, UVSQ, UMR Inserm 1179, France.
Benjamin M BruckerFrom the MS Center for Innovations in Care (M.T.), St. Louis, MO; Sorbonne Universités (E.C.-K.), UPMC Paris 6, Pitié Salpétrière Academic Hospital, AP-HP, Paris, UMR Inserm 1179, France; Advanced Urology Centers (A.K.), Bethpage, NY; Université de Liège (V.K.), Belgium; New York University Langone Medical Center (B.M.B), New York; Urology Associates/Urologic Medical Research (B.E.), Kitchener, Ontario, Canada; Evidence Scientific Solutions (M.M.), Philadelphia, PA; Allergan plc (J.P.N., B.J.), Irvine, CA; and Hôpital Raymond Poincaré (P.D.), Garches, UVSQ, UMR Inserm 1179, France.
Blair EgerdieFrom the MS Center for Innovations in Care (M.T.), St. Louis, MO; Sorbonne Universités (E.C.-K.), UPMC Paris 6, Pitié Salpétrière Academic Hospital, AP-HP, Paris, UMR Inserm 1179, France; Advanced Urology Centers (A.K.), Bethpage, NY; Université de Liège (V.K.), Belgium; New York University Langone Medical Center (B.M.B), New York; Urology Associates/Urologic Medical Research (B.E.), Kitchener, Ontario, Canada; Evidence Scientific Solutions (M.M.), Philadelphia, PA; Allergan plc (J.P.N., B.J.), Irvine, CA; and Hôpital Raymond Poincaré (P.D.), Garches, UVSQ, UMR Inserm 1179, France.
Meryl MandleFrom the MS Center for Innovations in Care (M.T.), St. Louis, MO; Sorbonne Universités (E.C.-K.), UPMC Paris 6, Pitié Salpétrière Academic Hospital, AP-HP, Paris, UMR Inserm 1179, France; Advanced Urology Centers (A.K.), Bethpage, NY; Université de Liège (V.K.), Belgium; New York University Langone Medical Center (B.M.B), New York; Urology Associates/Urologic Medical Research (B.E.), Kitchener, Ontario, Canada; Evidence Scientific Solutions (M.M.), Philadelphia, PA; Allergan plc (J.P.N., B.J.), Irvine, CA; and Hôpital Raymond Poincaré (P.D.), Garches, UVSQ, UMR Inserm 1179, France.
Jean Paul NicandroFrom the MS Center for Innovations in Care (M.T.), St. Louis, MO; Sorbonne Universités (E.C.-K.), UPMC Paris 6, Pitié Salpétrière Academic Hospital, AP-HP, Paris, UMR Inserm 1179, France; Advanced Urology Centers (A.K.), Bethpage, NY; Université de Liège (V.K.), Belgium; New York University Langone Medical Center (B.M.B), New York; Urology Associates/Urologic Medical Research (B.E.), Kitchener, Ontario, Canada; Evidence Scientific Solutions (M.M.), Philadelphia, PA; Allergan plc (J.P.N., B.J.), Irvine, CA; and Hôpital Raymond Poincaré (P.D.), Garches, UVSQ, UMR Inserm 1179, France.
Brenda JenkinsFrom the MS Center for Innovations in Care (M.T.), St. Louis, MO; Sorbonne Universités (E.C.-K.), UPMC Paris 6, Pitié Salpétrière Academic Hospital, AP-HP, Paris, UMR Inserm 1179, France; Advanced Urology Centers (A.K.), Bethpage, NY; Université de Liège (V.K.), Belgium; New York University Langone Medical Center (B.M.B), New York; Urology Associates/Urologic Medical Research (B.E.), Kitchener, Ontario, Canada; Evidence Scientific Solutions (M.M.), Philadelphia, PA; Allergan plc (J.P.N., B.J.), Irvine, CA; and Hôpital Raymond Poincaré (P.D.), Garches, UVSQ, UMR Inserm 1179, France.
Pierre DenysFrom the MS Center for Innovations in Care (M.T.), St. Louis, MO; Sorbonne Universités (E.C.-K.), UPMC Paris 6, Pitié Salpétrière Academic Hospital, AP-HP, Paris, UMR Inserm 1179, France; Advanced Urology Centers (A.K.), Bethpage, NY; Université de Liège (V.K.), Belgium; New York University Langone Medical Center (B.M.B), New York; Urology Associates/Urologic Medical Research (B.E.), Kitchener, Ontario, Canada; Evidence Scientific Solutions (M.M.), Philadelphia, PA; Allergan plc (J.P.N., B.J.), Irvine, CA; and Hôpital Raymond Poincaré (P.D.), Garches, UVSQ, UMR Inserm 1179, France.
Scientific Solutions (United States) · USAllergan (United States) · USNYU Langone Health · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the efficacy and safety of onabotulinumtoxinA 100 U in noncatheterizing patients with multiple sclerosis (MS) with urinary incontinence (UI) due to neurogenic detrusor overactivity (NDO).

methodsIn this randomized, double-blind phase III study, patients received onabotulinumtoxinA 100 U (n = 66) or placebo (n = 78) as intradetrusor injections via cystoscopy. Assessments included changes from baseline in urinary symptoms, urodynamics, and Incontinence-Quality of Life (I-QOL) total score. Adverse events (AEs) were assessed, including initiation of clean intermittent catheterization (CIC) due to urinary retention.

resultsOnabotulinumtoxinA vs placebo significantly reduced UI at week 6 (-3.3 episodes/day vs -1.1 episodes/day,

conclusionIn noncatheterizing patients with MS, onabotulinumtoxinA 100 U significantly improved UI and quality of life with lower CIC rates than previously reported with onabotulinumtoxinA 200 U. CLINICALTRIALSGOV IDENTIFIER: NCT01600716. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that compared with placebo, 100 U onabotulinumtoxinA intradetrusor injections significantly reduce UI and improve quality of life in noncatheterizing patients with MS and NDO.

Indexed as

AdultBotulinum Toxins, Type ADose-Response Relationship, DrugDouble-Blind MethodEuropeFemaleFollow-Up StudiesHumansMaleMiddle AgedMultiple SclerosisNeurotoxinsNorth AmericaQuality of LifeTreatment OutcomeUrodynamicsBotulinum Toxins, Type ANeurotoxinsonabotulinum toxin A

Identifiers

PMID30030330
PMCPMC6105039
OpenAlexW2883525943

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.