Trial reportBMC geriatrics2020
Effect of mirabegron on cognitive function in elderly patients with overactive bladder: MoCA results from a phase 4 randomized, placebo-controlled study (PILLAR).
Trial report in BMC geriatrics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02216214 (A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder), which is not on this map. Cited by 36 papers, 3 of them syntheses that pooled 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.
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.
A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB)
Who cites it
36 citing papers in PubMed, 3 syntheses or guidelines pooled it, 65 citations in OpenAlex.
- Pooled it
- Anticholinergic deprescribing interventions for reducing risk of cognitive decline or dementia in older adults with and without prior cognitive impairment.The Cochrane database of systematic reviews · 2023Pooled it
- A systematic review of neurocognitive dysfunction with overactive bladder medications.International urogynecology journal · 2021Pooled it
- Radiofrequency as the New Opportunity in Treating Overactive Bladder and Urge Urinary Incontinence-A Single-Arm Pilot Study.Medicina (Kaunas, Lithuania) · 2024Trial
- The effect of oral medications on fMRI brain activation: A randomized, double blind, controlled pilot trial of older women with overactive bladder.International urogynecology journal · 2023Trial
- The effect of oral medications on fMRI brain activation: A randomized, double blind, controlled pilot trial of older women with overactive bladder.International urogynecology journal · 2023Trial
- Vibegron for the Treatment of Patients with Dry and Wet Overactive Bladder: A Subgroup Analysis from the EMPOWUR Trial.International journal of clinical practice · 2022Trial
- Trial
- Trial
- Bladder Antimuscarinic Use and Cognitive Impairment in Adults Aged 75 Years or Older With Urinary Incontinence or Overactive Bladder Symptoms: A Population-Based Study.Pharmacoepidemiology and drug safety · 2026Article
- A Retrospective Database Analysis of Anticholinergic Burden Among Older Patients With and Without Overactive Bladder in South Korea.International neurourology journal · 2025Article
- Overactive bladder medications and risk of emergency hospital admissions with delirium in adults without dementia: self-controlled case series.Age and ageing · 2025Article
- Drug-Induced Cognitive Impairment.Drug safety · 2025Review
- Overactive bladder drugs and the risk of dementia.BMJ medicine · 2025Article
- Article
- Frailty recommendations and guidelines: an evaluation of the implementability and a critical appraisal of clinical applicability by the ISPRM Frailty Focus Group.European journal of physical and rehabilitation medicine · 2024Article
- Treatment Patterns with Mirabegron and Antimuscarinics for Overactive Bladder: A Prospective, Registry Study in Taiwan and South Korea (FAITH).Advances in therapy · 2024Observational
- Management of use of urinary antimuscarinics and alpha blockers for benign prostatic hyperplasia in older adults at risk of falls: a clinical review.European geriatric medicine · 2023Review
- Article
- Mirabegron for overactive bladder in frail patients 80 years or over (HOKUTO study).BMC urology · 2022Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 6 institutions in 2 countries.
Funding
Abstract
backgroundAntimuscarinics are often used for treatment of overactive bladder (OAB), but exposure to medications such as antimuscarinics that have anticholinergic properties has been linked to adverse cognitive effects. A phase 4 placebo-controlled study (PILLAR; NCT02216214) described the efficacy and safety of mirabegron, a β
methodsOutpatients aged ≥65 years with wet OAB were randomized 1:1 to mirabegron or placebo, stratified by age (<75/≥75 years). There were no exclusion criteria regarding cognitive status. Patients randomized to mirabegron initially received 25 mg/day with an optional increase to 50 mg/day after week 4/8 based on patient/investigator discretion. The MoCA was administered at baseline and end of treatment (EoT, week 12). The study protocol was Independent Ethics Committee/Institutional Review Board-approved.
resultsOf the 887 randomized patients who received ≥1 dose of study drug, 72.3% were female, 79.5% were white, and 28.1% were aged ≥75 years. All patients had ≥1 comorbidity and 94.3% were receiving ≥1 concomitant medication. One third of patients had a history of psychiatric disorders, the most common being depression (17.2%), insomnia (15.7%), and anxiety (11.4%). Baseline mean (standard error, SE) MoCA total scores were 26.9 (0.1) and 26.8 (0.1) in the mirabegron and placebo groups, respectively. Among patients with MoCA data available at baseline/EoT, 27.1% (115/425) and 25.8% (106/411) of mirabegron and placebo group patients, respectively, had impaired cognitive function at baseline (MoCA total score <26). There was no statistically significant change in adjusted mean (SE) MoCA total score from baseline to EoT in the mirabegron group (-0.2 [0.1]) or the placebo group (-0.1 [0.1]).
conclusionsTreatment with mirabegron for 12 weeks did not contribute to drug-related cognitive side effects in patients aged ≥65 years, as measured by the MoCA. Furthermore, the pattern of change in cognition over time in an older OAB trial population does not appear to differ from that of subjects receiving placebo.
trial registrationNCT02216214 (prospectively registered August 13, 2014).
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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.