Evidence map›Paper›PMID 31222714›Full record

ArticleAdvances in therapy2019

Factors Associated with Improvements in Patient-Reported Outcomes During Mirabegron or Antimuscarinic Treatment of Overactive Bladder Syndrome: A Registry Study (PERSPECTIVE).

Kevin V Carlson, Eric S Rovner, Kavita V Nair, Anna S Deal, Rita M Kristy, Carol R Schermer

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in Advances in therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02386072 (A Prospective, Non-interventional, Registry Study of Patients Initiating a Course of DrugTherapy for Overactive Bladder), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
2.7field-weighted citation impact, top 11% 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.

NCT02386072 completednot on this map

A Prospective, Non-interventional, Registry Study of Patients Initiating a Course of DrugTherapy for Overactive Bladder (OAB)

TypeobservationalSponsorAstellas Scientific & Medical Affairs, Inc.Ran2015 to 2017Enrolled1,524ConditionsUrinary Bladder Overactive, Overactive Bladder, Urinary Bladder Diseases, Urologic DiseasesArmsmirabegron, antimuscarinic medication
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Mirabegron and Anticholinergics in the Treatment of Overactive Bladder Syndrome: A Meta-analysis.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2023
    Pooled it
  2. Observational
  3. Article
  4. Mirabegron in the Management of Overactive Bladder Syndrome.International journal of women's health · 2022
    Review
  5. Article
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

6 authors at 4 institutions in 2 countries.

Kevin V CarlsonSection of Urology, Department of Surgery, University of Calgary, Calgary, AB, Canada. Kevin.Carlson@albertahealthservices.ca.
Eric S RovnerDepartment of Urology, Medical University of South Carolina, Charleston, SC, USA.
Kavita V NairCenter for Pharmaceutical Outcomes Research, Department of Clinical Pharmacy, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Anschutz Medical Campus, Aurora, CO, USA.
Anna S DealIPC/TeamHealth, Johnson City, TN, USA.
Rita M KristyAstellas Pharma Global Development, Inc., Northbrook, IL, USA.
Carol R SchermerAstellas Pharma Global Development, Inc., Northbrook, IL, USA.
Astellas Pharma (United States) · USMedical University of South Carolina · USUniversity of Calgary · CAUniversity of Colorado Anschutz Medical Campus · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPatient-reported outcomes (PROs) provide valuable insights about the effectiveness of overactive bladder (OAB) treatments. The aim of PERSPECTIVE (a Prospective, non-intErventional Registry Study of PatiEnts initiating a Course of drug Therapy for overactIVE bladder) was to provide real-world evidence from the USA and Canada on patient-perceived effectiveness and safety of mirabegron and antimuscarinics for treating OAB symptoms.

methodsThis prospective, non-interventional registry followed adult patients with OAB who were starting treatment with mirabegron or antimuscarinics. All treatment decisions were made at the discretion of the treating healthcare provider with no mandatory visits after enrollment. The primary objective was to identify factors associated with improved treatment effectiveness from a patient perspective mainly using the OAB Questionnaire Short-Form (OAB-q SF). The form was sent to patients via email link at baseline and months 1, 3, 6, and 12. Treatment-emergent adverse event (TEAE) data were collated from investigator reports.

resultsOverall, 1514 patients were included (female 73.5%, mean age 62.2 years). Mirabegron was initiated by 613 patients and antimuscarinics by 901 patients. A PRO response rate of approximately 60% was achieved (575 patients did not complete baseline PROs). Similar improvements in OAB-q SF symptom bother score and health-related quality of life (HRQoL) total score were observed for mirabegron and antimuscarinic initiators. Covariate-adjusted models demonstrated that worse baseline PRO score, Hispanic ethnicity, being treatment naïve, and use of complementary/supportive OAB therapies at baseline were significantly associated with greater improvements in both scores. The most frequent TEAEs were gastrointestinal disorders (dry mouth, constipation, and nausea) and nervous system disorders (headache, somnolence, and dizziness).

conclusionThere are no differences between mirabegron and antimuscarinics in terms of patient-reported OAB symptom bother and HRQoL.

trial registrationClinicalTrials.gov identifier, NCT02386072.

fundingAstellas Pharma Global Development, Inc. Plain language summary available for this article.

Indexed as

AcetanilidesAgedCanadaFemaleHumansMaleMiddle AgedMuscarinic AntagonistsPatient Reported Outcome MeasuresProspective StudiesQuality of LifeRegistriesSurveys and QuestionnairesThiazolesTreatment OutcomeUnited StatesAcetanilidesMuscarinic AntagonistsThiazolesUrological AgentsAntimuscarinicMirabegronOveractive bladder syndromePatient-reported outcomesRegistryUrology

Identifiers

PMID31222714
PMCPMC6822866
OpenAlexW2949352054

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.