Mirabegron for urinary incontinence in women
Näytönastekatsaukset
31.3.2026
Level of evidence: B
Mirabegron probably decreases incontinence episodes slightly in patients with overactive bladder.
In a systematic review on Mirabegron to treat overactive bladder symptoms «Dey A, Georgiadis G, Umezurike J, et al. Mirabegron Versus Placebo and Other Therapeutic Modalities in the Treatment of Patients with Overactive Bladder Syndrome-A Systematic Review. Eur Urol Focus 20»1, Mirabegron decreased urge urinary incontinence episodes for -0,41 episodes per day (-0.56 to -0.26, about 23 % decrease).
Mirabegron 50mg probably has little to no impact on health-related quality of life compared to placebo (mean difference 2.28, 95% CI 0.66 to 3.90).
Specific adverse effects were not reported, however dropout rates due to adverse effects were similar between placebo and mirabegron groups (OR 1.17, 95% CI 0.89–1.54).
The effect of vibegron decreasing urge urinary incontinence episodes is similar to solifenacin and mirabegron. The dropout rates due to adverse events for mirabegron and vigebron are also similar «Kennelly M, Wielage R, Shortino D, et al. Long-term efficacy and safety of vibegron versus mirabegron and anticholinergics for overactive bladder: a systematic review and network meta-analysis. Drugs »2, «Shi H, Chen H, Zhang Y, et al. The efficacy and safety of Vibegron in treating overactive bladder: A systematic review and pooled analysis of randomized controlled trials. Neurourol Urodyn 2020;39(5):»4.
| Reference | Study type | Population | Intervention and comparison | Outcomes | Risk of bias |
|---|---|---|---|---|---|
| RCT=randomized controlled trial; SR=systematic review; MA=meta-analysis; TAE=treatment-related adverse event | |||||
| «Dey A, Georgiadis G, Umezurike J, et al. Mirabegron Versus Placebo and Other Therapeutic Modalities in the Treatment of Patients with Overactive Bladder Syndrome-A Systematic Review. Eur Urol Focus 20»1 | SR | Adult women and/or men (≥18 yr) with OAB | Mirabegron vs No treatment, placebo/sham or anticholinergic drugs | Improvement of OAB symptoms
TAEs Patient satisfaction Change in functional bladder capacity | Moderate |
| «Kennelly M, Wielage R, Shortino D, et al. Long-term efficacy and safety of vibegron versus mirabegron and anticholinergics for overactive bladder: a systematic review and network meta-analysis. Drugs »2 | SR/network MA | Adults with non-neurogenic OAB | Vibegron 75 mg or Mirabegron 25/50 mg or anticholinergics vs placebo or other OAB medication | Incontinence episodes, micturitions, and total volume voided per micturition; safety (check below for more info) | High |
| «Athanasiou S, Pitsouni E, Grigoriadis T, et al. Mirabegron in female patients with overactive bladder syndrome: What's new? A systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol 2020»3 | SR/MA | Female patients with OAB | Mirabegron vs. anticholinergics or placebo or no treatment or laser | Frequency, nocturia, urgency and urge incontinence, degree of symptoms bothering, sexual function, quality of life questionnaires, patients' global impression of improvement (PGI-I), persistence rates to treatment, postvoiding residual volume and urodynamic data. | High |
| «Shi H, Chen H, Zhang Y, et al. The efficacy and safety of Vibegron in treating overactive bladder: A systematic review and pooled analysis of randomized controlled trials. Neurourol Urodyn 2020;39(5):»4 | SR, MA | Adult women and/or men (≥18 yr) with OAB | Vibegron vs. placebo | Micturitions, urgency episodes, urgency incontinence epi-sodes, incontinence episodes, volume voided/micturition, TAEs | Moderate |
| Reference | Comments |
|---|---|
| «Dey A, Georgiadis G, Umezurike J, et al. Mirabegron Versus Placebo and Other Therapeutic Modalities in the Treatment of Patients with Overactive Bladder Syndrome-A Systematic Review. Eur Urol Focus 20»1 | Twenty-eight RCTs (n = 27 481 randomized participants) Inclusion criteria: Adult women and/or men (18 yr) with OAB syndrome defined as presence of ‘‘urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection or other obvious pathology '' Individuals with mixed urinary incontinence were also to be included. Exclusion criteria: Individuals with stress urinary incontinence and those with OAB symptoms attributed to any comorbid condition that may directly impact bladder function (complicated OAB) or result in nocturnal/global polyuria and any drug side effects will be excluded. Other comparators: Nonpharmacological treatment: (1) lifestyle interventions (including exercise, weight reduction, caffeine intake reduction, fluid management, smoking cessation, etc.); (2) behavioural/physical therapies (including prompted voiding, bladder training, pelvic floor muscle training, electrical/electromagnetic stimulation of the pelvic floor, posterior tibial nerve stimulation) Risk of bias: Moderate. SR: Incl+ex criteria ok, search ok, reporting outcomes ok. Original studes: Moderate (missing data on allocation concealment, blinding of outcome assessment, random sequence generation. Some incomplete outcome data.) |
| «Kennelly M, Wielage R, Shortino D, et al. Long-term efficacy and safety of vibegron versus mirabegron and anticholinergics for overactive bladder: a systematic review and network meta-analysis. Drugs »2 | 5 publications and 1 study report describing 5 unique RCTs with evaluable data were included in the analyses = 4622 Risk of bias: High. Complete data on search strategy and clear inclusion/exclusion criteria missing. Original studies on efficacy (n=3): one with missing data on blinding and randomizing, 1 good quality and one |
| «Athanasiou S, Pitsouni E, Grigoriadis T, et al. Mirabegron in female patients with overactive bladder syndrome: What's new? A systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol 2020»3 | Inclusion criteria: publications in English language, full texted, prospective study design, providing data of mirabegron's evaluation in female patients with OAB. Exclusion criteria: Studies including data from both women and men without providing specific data in female patients, as well as studies evaluating patients with underlying neurological disorders (i.e spinal cord injury, Parkinson's disease) or pharmacokinetics parameters were excluded from this review. 21 studies with 2381 participants were included in this review. Safety outcomes: treatment-emergent adverse events and specific adverse events including dry mouth, constipation, blurred vision, and tachycardia; withdrawals for any reason Risk of bias: High. Original studies: small sample sizes, not all studies were RCTs, a lot of missing data on allocation, randomization, patients lost to follow up |
| «Shi H, Chen H, Zhang Y, et al. The efficacy and safety of Vibegron in treating overactive bladder: A systematic review and pooled analysis of randomized controlled trials. Neurourol Urodyn 2020;39(5):»4 | Three high-quality RCTs involving a total of 2120 OAB patients were adopted in the systematic review and pooled analysis RCTs accorded with the following inclusion criteria: (a) Vibegron in treating OAB was studied, (b) articles provided sufficient data for analysis mainly including number of the patients with OAB symptoms, the mean number of micturitions episodes/d, the mean number of urgency episodes/d, mean number of urgency incontinence episodes/d, mean number of incontinence episodes/d, mean volume voided/micturition, dry mouth, drug‐related treatment‐emergent adverse event (TEAE), serious ad-verse event (SAE), and discontinuations due to adverse event (AE), and (c) full text available. The article would be excluded from the pooled analysis if the above inclusion criteria were not met. Risk of bias: Moderate. High dropout rates. |
Results
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Mean (sd) I | Mean (sd) C | Mean difference (95% CI), fixed |
|---|---|---|---|---|---|
| Level of evidence: moderate The quality of evidence is downgraded due to moderate risk of bias. The analysis used fixed effects model, likely leading to too precise estimates. I=intervention; C=comparison; CI=confidence interval, MD=mean difference *not calculated by the study authors | |||||
| «Dey A, Georgiadis G, Umezurike J, et al. Mirabegron Versus Placebo and Other Therapeutic Modalities in the Treatment of Patients with Overactive Bladder Syndrome-A Systematic Review. Eur Urol Focus 20»1 | 11 RCTs, n=4257 | 0-3 months | 1.77* | -0.41 (-0.52 to -0.31) relative effect: -23 % (-18 % to -29 %) | |
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Mean (sd) I | Mean (sd) C | Mean difference (95% CI), fixed |
|---|---|---|---|---|---|
| Level of evidence: moderate The quality of evidence is downgraded due to moderate risk of bias. I=intervention; C=comparison; CI=confidence interval, MD=mean difference *not calculated by the study authors | |||||
| «Dey A, Georgiadis G, Umezurike J, et al. Mirabegron Versus Placebo and Other Therapeutic Modalities in the Treatment of Patients with Overactive Bladder Syndrome-A Systematic Review. Eur Urol Focus 20»1 | 10 RCTs, n=4326 | 0-3 months | 1.57* | MD -0.44 (-0.55 to -0.33) relative effect: -28 % (-21 % to -35 %) | |
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Mean (sd) I | Mean (sd) C | Mean difference (95% CI), fixed |
|---|---|---|---|---|---|
| Level of evidence: moderate The quality of evidence is downgraded due to moderate risk of bias. I=intervention; C=comparison; CI=confidence interval, MD=mean difference *not calculated by the study authors | |||||
| «Dey A, Georgiadis G, Umezurike J, et al. Mirabegron Versus Placebo and Other Therapeutic Modalities in the Treatment of Patients with Overactive Bladder Syndrome-A Systematic Review. Eur Urol Focus 20»1 | 3 RCTs, n=1750 | 0-3 months | 2.28 (0.66 to 3.9) | ||
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Absolute number of events (%) I | Absolute number of events (%) C | Relative effect (95% CI) |
|---|---|---|---|---|---|
| Level of evidence: moderate The quality of evidence is downgraded due to moderate risk of bias. I=intervention; C=comparison; CI=confidence interval, MD=mean difference | |||||
| «Dey A, Georgiadis G, Umezurike J, et al. Mirabegron Versus Placebo and Other Therapeutic Modalities in the Treatment of Patients with Overactive Bladder Syndrome-A Systematic Review. Eur Urol Focus 20»1 | 12 RCTs, n=7046 | 0-3 months | 3,3 % | 2,8 % | 0R 1.17 (0.89–1.54) |
References
- Dey A, Georgiadis G, Umezurike J, et al. Mirabegron Versus Placebo and Other Therapeutic Modalities in the Treatment of Patients with Overactive Bladder Syndrome-A Systematic Review. Eur Urol Focus 2025;11(2):323-336 «PMID: 39343691»PubMed
- Kennelly M, Wielage R, Shortino D, et al. Long-term efficacy and safety of vibegron versus mirabegron and anticholinergics for overactive bladder: a systematic review and network meta-analysis. Drugs Context 2022;11(): «PMID: 36303599»PubMed
- Athanasiou S, Pitsouni E, Grigoriadis T, et al. Mirabegron in female patients with overactive bladder syndrome: What's new? A systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol 2020;251():73-82 «PMID: 32480182»PubMed
- Shi H, Chen H, Zhang Y, et al. The efficacy and safety of Vibegron in treating overactive bladder: A systematic review and pooled analysis of randomized controlled trials. Neurourol Urodyn 2020;39(5):1255-1263 «PMID: 32421908»PubMed