The 2021 American Urological Association (AUA)/Society of Urodynamics, Female Pelvic Medicine & Urogenital (SUFU) reconstruction guideline on adult neurogenic lower urinary tract dysfunction focuses on the evaluation, risk stratification, surveillance, and overall management of adults with neurogenic lower urinary tract dysfunction. The panel emphasizes individualized treatment based on neurologic disease, cognition, functional status, and risk of upper urinary tract deterioration; however, it does not address the use of mirabegron specifically. [1]
A 2021 review on neurogenic bladder management recommendations states that mirabegron cannot be recommended or contraindicated over antimuscarinics as first-line oral therapy due to insufficient comparative evidence (conditional recommendation, low quality evidence). Studies in patients with spinal cord injury and multiple sclerosis suggest improvements in incontinence symptoms and, in some reports, bladder compliance; however, several included studies were uncontrolled case series and one trial showed benefit only when mirabegron was combined with desmopressin rather than as monotherapy. Adverse effects were generally well tolerated, with hypertension, tachycardia, urinary tract infections, dizziness, and headache most commonly reported, and monitoring is recommended in patients with cardiovascular disease. Mirabegron also demonstrates lower discontinuation rates and longer persistence compared with antimuscarinic agents, with dosing and drug interaction considerations in renal or hepatic impairment and with cytochrome P450 (CYP450)-mediated medications. [2]
According to the 2026 European Association of Urology (EAU) guidelines on neuro-urology, evidence supporting mirabegron in patients with neurogenic lower urinary tract dysfunction remains limited. Although mirabegron has demonstrated improvements in lower urinary tract symptoms and quality of life comparable to antimuscarinics, available studies in patients with multiple sclerosis and spinal cord injury have not shown significant improvements in urodynamic parameters, including detrusor pressure or maximum cystometric capacity. Mirabegron has generally been well tolerated, with randomized controlled trial data supporting cardiovascular safety in patients with neurogenic detrusor overactivity, and studies in patients with Parkinson disease reporting no worsening of cognitive function and a lower risk of adverse effects compared with antimuscarinic agents. Overall, the guideline emphasizes that mirabegron provides similar symptom-related clinical benefits as antimuscarinic agents but does not improve urodynamic parameters in patients with neurogenic detrusor overactivity (level of evidence 1b). [3]
A 2016 review article discusses the medical management of neurogenic bladder with oral therapy and notes that mirabegron, a selective β3-adrenergic agonist, has a low adverse effect profile due to receptor specificity and is not expected to impair voiding function. Although data in neurogenic bladder populations are limited, studies in men with lower urinary tract symptoms and bladder outlet obstruction showed no significant changes in urine flow or detrusor pressure at maximum flow compared with placebo, with only a small increase in post-void residual at higher doses and no reported urinary retention requiring catheterization or cardiac adverse events. In a small study of patients with neurogenic bladder who failed antimuscarinics, mirabegron added to therapy was associated with improvements in detrusor overactivity, vesicoureteral reflux, and bladder compliance. The review notes that mirabegron is increasingly used in neurogenic patients who void, particularly those at risk for urinary retention from antimuscarinics, with generally mild adverse effects but suggest caution for the small increases in blood pressure and heart rate, and avoidance in patients with uncontrolled hypertension. [4]
A 2018 systematic review and network meta-analysis evaluated the efficacy and tolerability of mirabegron compared with antimuscarinic monotherapy or combination therapy in adults with non-neurogenic overactive bladder (OAB). The review included randomized controlled trials published between 2000 and 2017 with treatment durations of 4–16 weeks and incorporated data from 64 RCTs involving 46,666 participants. Mirabegron 50 mg was significantly more effective than placebo across all efficacy endpoints, including reductions in micturition frequency (mean difference [MD] 0.71; 95% credible interval [CrI] 0.55–0.87), urgency urinary incontinence (UUI) episodes (MD 0.40; 95% CrI 0.26–0.54), dry rate (OR 0.72; 95% CrI 0.64–0.82), and achieving a ≥50% reduction in incontinence episodes (OR 0.67; 95% CrI 0.57–0.79). Overall efficacy was comparable to most antimuscarinic monotherapies, although solifenacin 10 mg and combination therapy with solifenacin 5 mg plus mirabegron (25 mg or 50 mg) demonstrated superior efficacy for some endpoints. [5]
Regarding tolerability, mirabegron demonstrated a more favorable adverse effect profile than most antimuscarinic agents. The risk of dry mouth was significantly lower than 21 of 22 active comparators, constipation was lower than 9 of 20 comparators, and urinary retention was lower than 7 of 10 comparators. Rates of blurred vision, hypertension, urinary tract infection, and tachycardia were generally similar to placebo and other active treatments. The authors noted that mirabegron had similar efficacy to most antimuscarinic agents while avoiding many of the bothersome anticholinergic adverse effects that commonly lead to treatment discontinuation. Although this analysis excluded patients with neurogenic detrusor overactivity and therefore does not directly address neurogenic bladder or spinal cord dysfunction, its findings support mirabegron as an alternative pharmacologic option when avoidance of anticholinergic adverse effects is desirable. [5]
A 2021 systematic review and meta-analysis assessed the efficacy and safety of mirabegron for treating neurogenic lower urinary tract dysfunction (NLUTD). This investigation utilized data from four randomized controlled trials, involving a total of 245 patients with conditions such as spinal cord injury and neurological disorders like multiple sclerosis and Parkinson disease. The primary outcomes evaluated were bladder compliance, urinary incontinence episodes, Incontinence Quality of Life (I-QOL), Patient Perception of Bladder Condition (PPBC), and urinary urgency episodes. Safety outcomes included the incidence of drug-related adverse events, arrhythmias, hypertension, and post-voiding residual volume. The meta-analysis revealed that mirabegron treatment resulted in a significant improvement in bladder compliance (MD 19.53, 95% confidence interval 14.19 to 24.87, p<0.00001], urinary incontinence episodes (MD −0.78, 95% CI −0.89 to −0.67, p<0.00001), and I-QOL (MD 8.02, 95% CI 3.20 to 12.84, p=0.001). However, no significant differences were observed in PPBC or urinary urgency episodes when compared to placebo. Regarding safety, mirabegron did not show a significant difference from placebo in the incidence of adverse events, arrhythmias, hypertension, or changes in post-voiding residual volume. This analysis suggests that mirabegron is an effective and safe treatment for NLUTD, offering an alternative to traditional antimuscarinic therapy. [6]
A 2022 systematic review evaluated the efficacy and safety of mirabegron for the treatment of neurogenic detrusor overactivity (NDO) in adults suffering from spinal cord injury (SCI) or multiple sclerosis (MS). This review compiled data from 11 studies with a total of 488 patients. These studies varied in design, including 2 randomized, double-blind, placebo-controlled trials; 2 randomized comparative studies; 3 prospective cohort studies; 1 prospective comparative non-randomized study; and 3 retrospective studies. The treatment durations ranged from 4 weeks to 12 months, with mirabegron being used primarily as a second-line treatment following anticholinergics. Results from this systematic review indicated that mirabegron demonstrated similar clinical efficacy to anticholinergics in patients with MS, as evidenced by clinical outcome parameters. However, comprehensive urodynamic evaluations in the studies involving SCI patients, particularly in randomized controlled trials, did not show significant improvements in key urodynamic parameters such as maximum cystometric capacity or detrusor pressure, which are critical for assessing the risk of upper urinary tract deterioration. On the safety front, while mirabegron was generally well-tolerated with no significant changes in heart rate or blood pressure observed across most studies, occasional cardiovascular concerns such as tachycardia were reported. The review highlighted the need for further research, especially multicenter randomized studies, to better assess the role of mirabegron in NDO management, particularly in different subsets of neurogenic bladder patients. [7]
A 2023 systematic review and network meta-analysis evaluated the efficacy and safety of oral detrusor relaxing agents (DRAs), including antimuscarinics and mirabegron, in patients with NDO. The analysis included 23 randomized controlled trials involving 1,697 patients, including 16 trials evaluating antimuscarinics, 5 placebo-controlled trials of mirabegron, and 2 direct comparisons between mirabegron and antimuscarinics. Compared with placebo, oral DRAs were associated with significant improvements in patient perception of bladder condition (standardised mean difference [SMD] −0.509; 95% CI −0.897 to −0.121), incontinence-related quality of life (SMD 0.370; 95% CI 0.136 to 0.605), urinary incontinence episodes (SMD −0.734; 95% CI −1.317 to −0.150), maximum bladder capacity (SMD 0.640; 95% CI 0.210 to 1.069), volume at first contraction (SMD 0.819; 95% CI 0.621 to 1.018), maximum detrusor pressure (SMD −0.498; 95% CI −0.922 to −0.073), and bladder compliance (SMD 0.410; 95% CI 0.131 to 0.688), although total adverse events were more frequent (RR 1.380; 95% CI 1.032–1.846). [8]
In subgroup analyses, antimuscarinics significantly improved patient perception of bladder condition, urinary incontinence episodes, urinary frequency, residual urine volume, maximum bladder capacity, volume at first contraction, maximum detrusor pressure, and bladder compliance, but were associated with a significantly greater risk of adverse events (RR 1.565; 95% CI 1.082–2.263) and xerostomia (RR 4.819; 95% CI 2.340–9.923). Mirabegron significantly improved incontinence-related quality of life (SMD 0.617; 95% CI 0.210–1.023), volume at first contraction (SMD 0.898; 95% CI 0.481–1.315), and bladder compliance (SMD 0.661; 95% CI 0.165–1.158), while no significant differences versus placebo were observed for urinary incontinence episodes, urinary frequency, residual urine volume, maximum bladder capacity, maximum detrusor pressure, or overall adverse events (RR 1.157; 95% CI 0.722–1.854). Two randomized trials directly comparing mirabegron with antimuscarinics found no significant differences in efficacy or safety, and the network meta-analysis similarly found no antimuscarinic agent or mirabegron to be superior or inferior to another across evaluated efficacy and safety outcomes. It was suggested that although mirabegron may provide some clinical benefit with fewer bothersome anticholinergic adverse effects, evidence supporting mirabegron as first-line therapy for NDO remains limited, and additional well-designed randomized trials are needed. [8]
A 2024 individual participant data meta-analysis (IPDMA) analyzed the effects of mirabegron on NLUTD in patients with MS and SCI. The meta-analysis pooled data from two previously published randomized, placebo-controlled trials, which included a total of 98 patients. The primary outcomes evaluated were the change in maximum cystometric capacity and the PPBC. Secondary outcomes were the change in the peak pressure of NDO, volume at first NDO, urodynamic compliance, 24-hour pad weight, and an I‐QoL. The analyses were conducted using analysis of covariance, adjusting for baseline values for statistical robustness. The results highlighted a significant improvement in maximum cystometric capacity by 41 mL (p= 0.04) and in PPBC by 0.8 points in the mirabegron group compared to placebo (p<0.01). Secondary outcomes, such as peak NDO pressure and I-QoL scores, also showed significant improvements with mirabegron. Exploratory analyses within the meta-analysis suggested similar benefits among patients with MS and SCI, with some outcomes favoring those with incomplete SCI or SCIs below the T7 level. These findings underscore the potential benefit of mirabegron in managing NLUTD symptoms, suggesting a favorable profile for improving bladder capacity and patient quality of life in this specific population. [9]