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Efficacy and safety of mirabegron for the treatment of neurogenic detrusor overactivity—Prospective, randomized, double‐blind, placebo‐controlled study
Author(s) -
Krhut Jan,
Borovička Vladimír,
Bílková Karolína,
Sýkora Radek,
Míka David,
Mokriš Jan,
Zachoval Roman
Publication year - 2018
Publication title -
neurourology and urodynamics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 90
eISSN - 1520-6777
pISSN - 0733-2467
DOI - 10.1002/nau.23566
Subject(s) - medicine , mirabegron , placebo , overactive bladder , adverse effect , spinal cord injury , randomized controlled trial , anesthesia , urology , single center , incidence (geometry) , spinal cord , physics , alternative medicine , optics , pathology , psychiatry
Aims To assess the efficacy and safety of mirabegron in the treatment of neurogenic detrusor overactivity. Methods This prospective, multicenter, randomized, double‐blind, placebo‐controlled study was conducted in three tertiary centers, and included 78 patients suffering from spinal cord injury or multiple sclerosis. Patients were randomized for Mirabegron 50 mg (Group A) or placebo (Group B). Urodynamic parameters, the 24 h pad‐weight test, and patient‐reported outcomes were assessed. Safety assessments included monitoring the incidence and severity of adverse events. Changes in time and differences between groups were assessed with nonparametric Kruskal‐Wallis one‐way analysis of variance; P ≤ 0.05 was considered statistically significant. Results In total, 66 patients were eligible for inclusion in the final analysis. There was a significant increase of volume at the first detrusor contraction ( P = 0.00047) and an improvement in bladder compliance ( P = 0.0041) in the mirabegron group compared with the placebo‐treated group, whereas the increase in cystometric capacity did not reach statistical significance ( P = 0.061). There was a clear tendency to reduced urine leakage ( P = 0.056) in Group A. There were significant changes in all the patient‐reported outcomes, favoring the mirabegron group. The incidence of drug‐related adverse events was 3.13%. Conclusions Mirabegron (50 mg) improved both urodynamic variables and patient‐reported outcomes in patients with NDO. The treatment was tolerated well.