Evidence map›Paper›PMID 29673355›Full record

Trial reportHealth and quality of life outcomes2018

Patient-reported outcomes in patients with overactive bladder treated with mirabegron and tolterodine in a prospective, double-blind, randomized, two-period crossover, multicenter study (PREFER).

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

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Health and quality of life outcomes, 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 11 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 3 pooled it
2.3field-weighted citation impact, top 13% 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.

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

11 citing papers in PubMed, 3 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Article
  9. Review
  10. Mirabegron in the Management of Overactive Bladder Syndrome.International journal of women's health · 2022
    Review
  11. 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

7 authors at 5 institutions in 2 countries.

Sender HerschornSunnybrook Health Sciences Centre, University of Toronto, 2075 Bayview Avenue, MG408, Toronto, Ontario, M4N 3M5, Canada. s.herschorn@utoronto.ca.
David StaskinTufts University School of Medicine, Boston, MA, USA.
Le Mai TuUniversity of Sherbrooke, Quebec, Canada.
Jonathan FialkovThe Iowa Clinic, West Des Moines, IA, USA.
Terry WalshAstellas Pharma US, Northbrook, IL, USA.
Katherine GoochAstellas Pharma US, Northbrook, IL, USA.
Carol R SchermerAstellas Pharma US, Northbrook, IL, USA.
Astellas Pharma (United States) · USHealth Sciences Centre · CAIowa Lutheran Hospital · USTufts University · USUniversité de Sherbrooke · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe PREFER study was an assessment of medication tolerability, treatment preference and symptom improvement during treatment with mirabegron (M) and tolterodine (T) extended release (ER) in patients with overactive bladder (OAB). In this analysis of PREFER, patient-reported outcomes (PROs) were assessed during treatment.

methodsPREFER was a two-period, 8-week crossover, double-blind, phase IV study (NCT02138747) of treatment-naïve adults with OAB ≥3 months randomized to 1 of 4 treatment sequences (M/T; T/M; M/M; T/T), separated by a 2-week washout. Tolterodine ER was dosed at 4 mg for 8 weeks and mirabegron was dosed at 25 mg for 4 weeks then increased to 50 mg for the next 4 weeks. At each visit, PROs related to treatment satisfaction, quality of life and symptom bother were assessed using the OAB Satisfaction (OAB-S; 3 independent scales/5 single-item overall assessments), OAB-q (total health-related QoL [HRQoL] and subscales [Sleep, Social, Coping, Concern] and Symptom Bother scale) and Patient Perception of Bladder Condition (PPBC) questionnaires. Responder rates were reported for OAB-q subscales based on a minimal important difference (MID; ≥ 10-point improvement) and OAB-S Medication Tolerability score ≥ 90.

resultsIn total, 358 randomized patients received ≥1 dose of double-blind study medication and completed ≥1 post-baseline value (OAB-S scale, OAB-q, PPBC): M/T (n = 154), T/M (n = 144), M/M (n = 30) or T/T (n = 30). At end of treatment (EoT), mirabegron and tolterodine ER were associated with similar mean improvements in 7 of the 8 OAB-S scores investigated, OAB-q scales and PPBC. A higher percentage of patients achieved clinically relevant improvements (MID) in OAB-q scales and OAB-S Medication Tolerability score during treatment with mirabegron than tolterodine ER.

conclusionsOn average, patients with OAB experienced improvements in treatment satisfaction, HRQoL and symptom bother that were of a similar magnitude during treatment with mirabegron or tolterodine ER. However, during mirabegron treatment, patients were more likely to achieve clinically relevant improvements in tolerability and HRQoL (as measured by the MID for the OAB-q or an OAB-S Medication Tolerability score ≥ 90) than during tolterodine ER treatment.

trial registrationNCT02138747 ; registered May 13, 2014.

Indexed as

Patient Reported Outcome MeasuresQuality of LifeAcetanilidesAdultAgedCross-Over StudiesDouble-Blind MethodFemaleHumansMaleMiddle AgedPatient SatisfactionProspective StudiesThiazolesTolterodine TartrateUrinary Bladder, OveractiveAcetanilidesmirabegronThiazolesTolterodine TartrateUrological AgentsHealth-related quality of lifeMirabegronOAB-questionnaireOAB-satisfactionOveractive bladderPatient Perception of Bladder ConditionPatient-reported outcomesTolterodine ER

Identifiers

PMID29673355
PMCPMC5909214
OpenAlexW2801845647

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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.