Efficacy and safety of mirabegron for the treatment of neurogenic detrusor overactivity-Prospective, randomized, double-blind, placebo-controlled study
| Autor: | Roman Zachoval, David Míka, Jan Krhut, Vladimír Borovička, Jan Mokriš, Karolina Bilkova, Radek Sýkora |
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| Rok vydání: | 2018 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent Urology 030232 urology & nephrology Placebo-controlled study Placebo Young Adult 03 medical and health sciences 0302 clinical medicine Double-Blind Method Statistical significance Humans Medicine Patient Reported Outcome Measures Prospective Studies Adverse effect Spinal cord injury Neurogenic bladder dysfunction Aged Urinary Bladder Overactive business.industry Middle Aged medicine.disease Thiazoles Urodynamics Treatment Outcome 030220 oncology & carcinogenesis Urological Agents Acetanilides Female Neurology (clinical) Analysis of variance business Mirabegron medicine.drug |
| Zdroj: | Neurourology and Urodynamics. 37:2226-2233 |
| ISSN: | 0733-2467 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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