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

Welk, Blayne; Hickling, Duane; McKibbon, Mary; Radomski, Sidney B.; Ethans, Karen

doi:10.1002/nau.23774

Cited by 45 publications

(54 citation statements)

References 31 publications

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“…No significant change in BP was noted, which was expected, especially considering the fact that the present population was younger (mean age 36 years). This is in accordance with the previously reported good tolerability profile of the drug 11,12,14 …”

Section: Discussionsupporting

confidence: 93%

“…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 another randomized, double blind, placebo‐controlled study that recruited patients with SCI or multiple sclerosis, although there was a trend toward a lower peak NDO pressure and a higher volume at first NDO, these did not reach statistical significance 12 . Also, bladder capacity did not significantly increase in those who received mirabegron.…”

Section: Discussionmentioning

confidence: 95%

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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: Discussionsupporting

confidence: 93%

Section: Discussioncontrasting

confidence: 82%

Section: Discussionmentioning

confidence: 95%

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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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“…It can be used for patients who void spontaneously, use indwelling catheters, clean intermittent catheterization (CIC), condom catheters, or those who have reconstructive bladder surgery or urinary diversions. It is responsive to change, 4 has been validated in multiple datasets, 5,6 used in several studies, 7,8 and licensed to more than 75 investigators in over 30 countries.…”

Section: Introductionmentioning

confidence: 99%

The creation and validation of a short form of the Neurogenic Bladder Symptom Score

Welk

Lenherr

Elliott

et al. 2020

Neurourology and Urodynamics

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Aim: To develop a short form (SF) of the 24-item Neurogenic Bladder Symptom Score (NBSS). Methods:We used three previously published datasets. First, we selected the most responsive questions within each of the domains. Internal validity of the NBSS-SF was assessed using Cronbach's α. External validity was assessed by evaluating hypothesized relationships with other questionnaires and testing correlations with the full NBSS domains. Test-retest reliability of the NBSS-SF domains was determined using an intraclass coefficient (ICC).

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

Abstract: Among patients with SCI or MS, we demonstrated non-significant trends towards improvement in some urodynamic parameters with mirabegron 50 mg compared to placebo, and a significantly lower neurogenic bladder symptom burden.

Cited by 45 publications

References 31 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

The creation and validation of a short form of the Neurogenic Bladder Symptom Score

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

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