Evidence map›Paper›PMID 35685566›Full record

Trial reportInternational journal of clinical practice2022

Vibegron for the Treatment of Patients with Dry and Wet Overactive Bladder: A Subgroup Analysis from the EMPOWUR Trial.

David Staskin, Jeffrey Frankel, Susann Varano, Michael Kennelly, Diane K Newman, Matt T Rosenberg, Denise D Shortino, Rachael A Jankowich, Paul N Mudd

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of clinical practice, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03492281 (An International Phase 3, Randomized, Double-Blind, Placebo- and Active), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 9% 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.

NCT03492281 phase3completednot on this map

An International Phase 3, Randomized, Double-Blind, Placebo- and Active (Tolterodine)-Controlled Multicenter Study to Evaluate the Safety and Efficacy of Vibegron in Patients With Symptoms of Overactive Bladder

TypeinterventionalSponsorUrovant Sciences GmbHRan2018 to 2019Enrolled1,530ConditionsOveractive BladderArmsvibegron, Vibegron placebo, Tolterodine Tartrate ER, Tolterodine placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. 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

9 authors at 7 institutions in 1 country.

David StaskinTufts University School of Medicine, Boston, MA, USA.ORCID https://orcid.org/0000-0003-4972-765X
Jeffrey FrankelSeattle Urology Research Center, Seattle, WA, USA.ORCID https://orcid.org/0000-0002-0142-9015
Susann VaranoClinical Research Consulting, Milford, CT, USA.
Michael KennellyCarolinas Medical Center, Charlotte, NC, USA.ORCID https://orcid.org/0000-0002-7044-506X
Diane K NewmanPerelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Matt T RosenbergMid-Michigan Health Centers, Jackson, MI, USA.
Denise D ShortinoUrovant Sciences, Irvine, CA, USA.
Rachael A JankowichUrovant Sciences, Irvine, CA, USA.
Paul N MuddUrovant Sciences, Irvine, CA, USA.
Myovant Sciences (United States) · USCarolinas Medical Center · USClinical Research Consulting · USMercy Health · USSeattle University · USTufts University · USUniversity of Pennsylvania · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Overactive bladder (OAB) is characterized by urgency and frequency with (OAB wet) or without (OAB dry) urge urinary incontinence (UUI). In the phase 3 EMPOWUR trial, vibegron-a selective Methods: Patients were randomly assigned 5:5:4 to receive once-daily vibegron 75 mg, placebo, or tolterodine 4 mg extended release, respectively, for 12 weeks. Baseline criteria for OAB dry included an average of ≥8 micturitions, ≥3 urgency episodes, and <1 UUI episode per diary day and for OAB wet included an average of ≥8 micturitions and ≥1 UUI episode per diary day. Change from baseline in mean daily number of urgency episodes and micturitions was assessed in both populations. Results: Of the 1463 patients included in the full analysis set, 336 (23%) had OAB dry (vibegron, Conclusions: In this subgroup analysis from the EMPOWUR trial, vibegron was associated with significant reductions compared with placebo in urgency episodes and micturitions in both the OAB dry and wet populations, suggesting that vibegron is similarly efficacious for these endpoints in patients with and without UUI. This trial is registered with NCT03492281.

Indexed as

Urinary Bladder, OveractiveDouble-Blind MethodHumansPyrimidinonesPyrrolidinesTolterodine TartrateTreatment OutcomeUrinary Incontinence, UrgeN-(4-((5-(hydroxy(phenyl)methyl)pyrrolidin-2-yl)methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo(1,2-a)pyrimidine-6-carboxamidePyrimidinonesPyrrolidinesTolterodine Tartrate

Identifiers

PMID35685566
PMCPMC9159226
OpenAlexW4224039739

What OpenQuestion holds

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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.