Trial reportInternational urogynecology journal2013
A phase II dose-ranging study of mirabegron in patients with overactive bladder.
Trial report in International urogynecology journal, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03189511 (Short Term Effect of Fluvastatin on Brown Adipose Tissue Thermogenesis and Activity in Humans), which is not on this map. Cited by 50 papers, 7 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.
Short Term Effect of Fluvastatin on Brown Adipose Tissue Thermogenesis and Activity in Humans
Open the trial in the graphWho cites it
50 citing papers in PubMed, 7 syntheses or guidelines pooled it, 133 citations in OpenAlex.
- Guideline for Medication Management of Distressing Symptoms in Older Patients Receiving End-of-Life Palliative Care.Journal of evidence-based medicine · 2026Guideline
- Pooled it
- 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 · 2023Pooled it
- Updating the evidence on drugs to treat overactive bladder: a systematic review.International urogynecology journal · 2019Pooled it
- Factors influencing efficacy endpoints in clinical trials for new oral medicinal treatments for overactive bladder: a systematic literature review and meta-analysis.International urology and nephrology · 2018Pooled it
- Comparative assessment of efficacy and safety of approved oral therapies for overactive bladder: a systematic review and network meta-analysis.International braz j urol : official journal of the Brazilian Society of UrologyPooled it
- Overactive bladder - 18 years - Part II.International braz j urol : official journal of the Brazilian Society of UrologyPooled it
- Efficacy of novel βInternational journal of urology : official journal of the Japanese Urological Association · 2019Trial
- Regulation of Human Adipose Tissue Activation, Gallbladder Size, and Bile Acid Metabolism by a β3-Adrenergic Receptor Agonist.Diabetes · 2018Trial
- Human adipose beiging in response to cold and mirabegron.JCI insight · 2018Trial
- Combination treatment with mirabegron and solifenacin in patients with overactive bladder: exploratory responder analyses of efficacy and evaluation of patient-reported outcomes from a randomized, double-blind, factorial, dose-ranging, Phase II study (SYMPHONY).World journal of urology · 2017Trial
- Activation of human brown adipose tissue by a β3-adrenergic receptor agonist.Cell metabolism · 2015 · on this mapTrial
- Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults.The Cochrane database of systematic reviews · 2023Review
- Urinary Incontinence and Pelvic Organ Prolapse in Women.Deutsches Arzteblatt international · 2023Review
- Assessing Quality-of-Life of Patients Taking Mirabegron for Overactive Bladder.Therapeutics and clinical risk management · 2023Review
- The Efficiency and Safety of Mirabegron Monotherapy for the Treatment of Urge Incontinence in Women Aged >80 Years.Cureus · 2023Article
- Article
- Mirabegron in the Management of Overactive Bladder Syndrome.International journal of women's health · 2022Review
- Efficacy and safety of desmopressin on frequency and urgency in female patients with overactive bladder and nocturia, current clinical features and outcomes: A systematic review.Asian journal of urology · 2022Review
- Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 7 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introduction and hypothesisMirabegron is a potent and selective β3-adrenoceptor agonist that may represent an alternative treatment option in place of antimuscarinics for patients with overactive bladder.
methodsPatients completed a single-blinded, 2-week placebo run-in period followed by 12 weeks of randomized (n = 928) double-blinded treatment with mirabegron oral controlled absorption system (OCAS) 25, 50, 100, or 200 mg once-daily (QD), placebo or tolterodine extended release (ER) 4 mg QD. The primary endpoint was change from baseline to end-of-treatment in mean number of micturition episodes/24 h. Secondary endpoints included changes in mean volume voided per micturition; mean number of urinary incontinence, urgency urinary incontinence, and urgency episodes/24 h; severity of urgency; nocturia; and quality of life measures. Safety parameters included vital signs, adverse events, laboratory tests, electrocardiogram measurements and post-void residual volume.
resultsMirabegron 25, 50, 100, and 200 mg resulted in dose-dependent reductions (improvements) from baseline to end-of-treatment in micturition frequency of 1.9, 2.1, 2.1, and 2.2 micturitions/24 h respectively, versus 1.4 micturitions/24 h with placebo (p ≤ 0.05 for the mirabegron 50-, 100-, and 200-mg comparisons). There was a statistically significant improvement with mirabegron compared with placebo for most secondary endpoints including quality of life variables. While there was a significant (p < 0.05) increase from baseline in pulse rate in the mirabegron 100-mg and 200-mg groups, this was not associated with an increased incidence of cardiovascular adverse events.
conclusionsThe favorable efficacy and tolerability of mirabegron in this phase II dose-finding study has led to its successful advancement into a phase III clinical development program.
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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.