Efficacy and safety of mirabegron for the treatment of neurogenic detrusor overactivity—Prospective, randomized, double‐blind, placebo‐controlled study

Krhút, Jan; Borovička, Vladimír; Bilkova, Karolina; Sýkora, Radek; Míka, David; Mokriš, Jan; Zachoval, Roman

doi:10.1002/nau.23566

Cited by 61 publications

(74 citation statements)

References 26 publications

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“…The bladder compliance improved (increased nearly 10‐fold) and, overall, 88.2% of the patients responded. This is in contrast with findings in NDO patients, where the peak detrusor pressure did not reduce significantly and an improvement in compliance was not universally seen 11,12 . Also, the magnitude of improvement in patients who were on CIC for >6 months (already on CIC group) and those were started on CIC at inclusion in the study was similar.…”

Section: Discussioncontrasting

confidence: 82%

“…In a randomized, double blind, placebo‐controlled study evaluating the role of mirabegron in NDO resulting from SCI or multiple sclerosis, Krhut et al. reported on 66 patients, and concluded that the volume at first detrusor contraction and the bladder compliance significantly improved in the mirabegron group, whereas the increase in cystometric capacity and change in maximum detrusor pressure did not reach statistical significance 11 …”

Section: Discussionmentioning

confidence: 99%

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Efficacy and safety of mirabegron for the treatment of low compliance bladder resulting from sacral/infrasacral lesions: A prospective study

et al. 2020

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Objective: To assess the efficacy and safety of mirabegron in patients with sacral/ infrasacral lesions who have an acontractile detrusor and develop a low compliance bladder. Methods: This prospective study included adult patients with acontractile detrusor as a result of sacral/infrasacral lesions who develop a low compliance bladder (compliance <20 mL/cmH 2 O). All patients were asked to make a 48-h clean intermittent catheterization diary and underwent invasive urodynamics evaluation at the baseline, and were started on mirabegron 50 mg once daily. Patients were re-evaluated at 6 weeks with a repeat clean intermittent catheterization diary and invasive urodynamics, and the efficacy and safety of mirabegron was assessed. Results: A total of 17 patients were included. After 6 weeks of mirabegron therapy, the number of patients reporting leakage in between clean intermittent catheterization reduced from seven to two (P = 0.02), the end filling pressures reduced from 41.4 to 15.1 cmH 2 O (P = 0.003), the compliance increased from 9.8 to 99.9 mL/cmH 2 O (P = 0.000), and the number of patients where the end filling pressure was >40 cmH 2 O reduced from eight to one (P = 0.02). The cystometric bladder capacity did not change significantly. Similar effects were noted in patients who were already on clean intermittent catheterization or were started on clean intermittent catheterization at inclusion in the study. Mirabegron was well tolerated, none of the patients discontinued therapy or reported major side-effects. Conclusions: Mirabegron reduces end filling pressure, improves compliance and is safe in patients with a low compliance bladder resulting from a sacral/infrasacral lesion.

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Section: Discussioncontrasting

confidence: 82%

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of mirabegron for the treatment of low compliance bladder resulting from sacral/infrasacral lesions: A prospective study

et al. 2020

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“…However, most relevant to our study is a recent published trial that similarly examined mirabegron in patients with SCI and MS. Krhut et al randomized 66 Czechoslovakian patients with NDO due to MS or SCI to mirabegron or placebo. They found improvements in MMC, volume of first NDO, compliance, pad weights, and several patient‐reported outcome measures.…”

Section: Discussionmentioning

confidence: 99%

“…8 There is interest in using mirabegron for patients with NLUTD due to the potentially better safety and tolerability profile 5,9 ; however, there is limited evidence of its efficacy in this population. 10,11 There are potentially serious consequences of inadequately treated neurogenic bladder parameters; one study found that almost 20% of SCI patients required surgical invention for adverse urodynamic parameters over a 5-year period. 12 In some cases, bladder dysfunction can cause renal dysfunction (estimated at 5% after SCI, and uncommon among MS patients).…”

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confidence: 99%

A pilot randomized‐controlled trial of the urodynamic efficacy of mirabegron for patients with neurogenic lower urinary tract dysfunction

Welk

Hickling

McKibbon

et al. 2018

Neurourology and Urodynamics

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“…The β3‐adrenoceptor is involved in detrusor relaxation during the storage phase. The efficacy and safety of a β3‐adrenoceptor agonist (mirabegron) were evaluated in two small RCTs in SCI patients, and showed positive results without safety concerns . In Japan, a β3‐adrenoceptor agonist is approved only for treatment of OAB.…”

Section: Summary Of the Guidelinesmentioning

confidence: 99%

Clinical guidelines for the diagnosis and treatment of lower urinary tract dysfunction in patients with spinal cord injury

et al. 2020

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The present article is an abridged English translation of the Japanese clinical guidelines for the diagnosis and treatment of lower urinary tract dysfunction in patients with spinal cord injury updated as of July 2019. The patients are adult spinal cord injured patients with lower urinary tract dysfunction; special consideration of pediatric and elderly populations is presented separately. The target audience is healthcare providers who are engaged in the medical care of patients with spinal cord injury. The mandatory assessment includes medical history, physical examination, frequency‐volume chart, urinalysis, blood chemistry, transabdominal ultrasonography, measurement of post‐void residual urine, uroflowmetry and video‐urodynamic study. Optional assessments include questionnaires on the quality of life, renal scintigraphy and cystourethroscopy. The presence or absence of risk factors for renal damage and symptomatic urinary tract infection affects urinary management, as well as pharmacological treatments. Further treatment is recommended if the maximum conservative treatment fails to improve or prevent renal damage and symptomatic urinary tract infection. In addition, management of urinary incontinence should be considered individually in patients with risk factors for urinary incontinence and decreased quality of life.

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Efficacy and safety of mirabegron for the treatment of neurogenic detrusor overactivity—Prospective, randomized, double‐blind, placebo‐controlled study

Abstract: Mirabegron (50 mg) improved both urodynamic variables and patient-reported outcomes in patients with NDO. The treatment was tolerated well.

Cited by 61 publications

References 26 publications

Efficacy and safety of mirabegron for the treatment of low compliance bladder resulting from sacral/infrasacral lesions: A prospective study

Efficacy and safety of mirabegron for the treatment of low compliance bladder resulting from sacral/infrasacral lesions: A prospective study

A pilot randomized‐controlled trial of the urodynamic efficacy of mirabegron for patients with neurogenic lower urinary tract dysfunction

Clinical guidelines for the diagnosis and treatment of lower urinary tract dysfunction in patients with spinal cord injury

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