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

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064190%3A_____%2F18%3AN0000010" target="_blank" >RIV/00064190:_____/18:N0000010 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00843989:_____/18:E0107230

Výsledek na webu

<a href="https://onlinelibrary-1wiley-1com-1wos.han.medvik.cz/resolve/doi?DOI=10.1002/nau.23566" target="_blank" >https://onlinelibrary-1wiley-1com-1wos.han.medvik.cz/resolve/doi?DOI=10.1002/nau.23566</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1002/nau.23566" target="_blank" >10.1002/nau.23566</a>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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 24h 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.

Název v anglickém jazyce

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

Popis výsledku anglicky

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 24h 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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30217 - Urology and nephrology

Projekt

—

Návaznosti

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Rok uplatnění

2018

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

NEUROUROLOGY AND URODYNAMICS

ISSN

0733-2467

e-ISSN

1520-6777

Svazek periodika

37

Číslo periodika v rámci svazku

7

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

8

Strana od-do

2226-2233

Kód UT WoS článku

000444957900022

EID výsledku v databázi Scopus

2-s2.0-85052201981