Evidence map›Paper›PMID 28620791›Full record

Trial reportInternational urogynecology journal2018

A prospective, double-blind, randomized, two-period crossover, multicenter study to evaluate tolerability and patient preference between mirabegron and tolterodine in patients with overactive bladder (PREFER study).

David Staskin, Sender Herschorn, Jonathan Fialkov, Le Mai Tu, Terry Walsh, Carol R Schermer

Registry-linked trialAbstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in International urogynecology journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02138747 (A Prospective, Double-Blind, Randomized, Two-Period Crossover, Multi-Center Study to Evaluate the Tolerability and Patient Preference Between Myrbetriq® and Detrol® LA in Subjects With Overactive Bladder), which is not on this map. Cited by 20 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 4 pooled it
–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.

NCT02138747 phase4completednot on this map

A Prospective, Double-Blind, Randomized, Two-Period Crossover, Multi-Center Study to Evaluate the Tolerability and Patient Preference Between Myrbetriq® and Detrol® LA in Subjects With Overactive Bladder (OAB)

TypeinterventionalSponsorAstellas Pharma Global Development, Inc.Ran2014 to 2015Enrolled376ConditionsOveractive Bladder (OAB)ArmsMirabegron, Tolterodine ER
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. 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
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Review
  12. Article
  13. Mirabegron in the Management of Overactive Bladder Syndrome.International journal of women's health · 2022
    Review
  14. Article
  15. Observational
  16. Mirabegron: a decade of study.Translational andrology and urology · 2020
    Article
  17. Article
  18. Article
  19. Review
  20. [Overactive bladder-which treatment when?]Der Urologe. Ausg. A · 2017
    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

6 authors.

David StaskinTufts University School of Medicine, Boston, MA, 02135, USA. staskin@att.net.
Sender HerschornSunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada.
Jonathan FialkovThe Iowa Clinic, West Des Moines, IA, USA.
Le Mai TuUniversity of Sherbrooke, Quebec, Canada.
Terry WalshAstellas Pharma US, Northbrook, IL, USA.
Carol R SchermerAstellas Pharma US, Northbrook, IL, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introduction and hypothesisThe objective of this study was to assess the tolerability and treatment preference in patients with overactive bladder (OAB) treated with mirabegron or tolterodine.

methodsThis was a two-period, 8-week crossover, double-blind, phase IV study (PREFER; NCT02138747) in treatment-naive adults with OAB for 3 months or longer randomized to one of four treatment sequences in a 5:5:1:1 ratio (mirabegron/tolterodine, tolterodine/mirabegron, mirabegron/mirabegron, or tolterodine/tolterodine), separated by a washout period of 2 weeks. The primary endpoint was drug tolerability using the Medication Tolerability scale of the OAB Treatment Satisfaction (OAB-S) questionnaire at end of treatment (EoT). Period-by-treatment interactions were analyzed to determine any effect of drug order. Patient preference, change from baseline in OAB symptoms, and treatment-emergent adverse events (TEAEs) were assessed.

resultsA total of 358 randomized patients completed the OAB-S Medication Tolerability scale questionnaire at one or more visits after the baseline evaluation. The mean (95% CI) OAB-S Medication Tolerability scores were significantly higher (better tolerability) for mirabegron (86.29 [83.50, 89.08]) than for tolterodine (83.40 [80.59, 86.20]; p = 0.004). The period-by-treatment interaction was not significant (p = 0.955). Improvements in OAB-S Medication Tolerability scores at EoT were more evident in women, patients aged ≥65 years, and in patients without baseline incontinence, and were greater with mirabegron than with tolterodine extended release. There were no significant differences in patient preference or improvements in OAB symptoms. Significant differences in favor of mirabegron were observed for anticholinergic TEAEs (20.4% vs. 27.4%; p = 0.042) and specifically for gastrointestinal disorders (14.7% vs. 22.5%; p = 0.015).

conclusionsTolerability of mirabegron was significantly higher than that of tolterodine, and patient preference and improvements in OAB symptoms were comparable. Both treatments were well tolerated; however, anticholinergic side effects were higher with tolterodine.

Indexed as

AcetanilidesAdultAgedCross-Over StudiesDouble-Blind MethodFemaleHumansMaleMiddle AgedPatient PreferenceProspective StudiesThiazolesTolterodine TartrateTreatment OutcomeUrinary Bladder, OveractiveUrological AgentsAcetanilidesmirabegronThiazolesTolterodine TartrateUrological AgentsAnticholinergic side effectsCrossover studyMirabegronOAB-S Medication Tolerability scalePatient preferenceTolterodine

Identifiers

PMID28620791
PMCPMC5780540

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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.