Intravesical instillation of onabotulinum toxin A embedded in inert hydrogel in the treatment of idiopathic overactive bladder: A double-blind randomized pilot study

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00843989%3A_____%2F16%3AE0105480" target="_blank" >RIV/00843989:_____/16:E0105480 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/61988987:17110/16:A1701IQ9

Výsledek na webu

<a href="http://dx.doi.org/10.3109/21681805.2015.1121406" target="_blank" >http://dx.doi.org/10.3109/21681805.2015.1121406</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.3109/21681805.2015.1121406" target="_blank" >10.3109/21681805.2015.1121406</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Intravesical instillation of onabotulinum toxin A embedded in inert hydrogel in the treatment of idiopathic overactive bladder: A double-blind randomized pilot study

Popis výsledku v původním jazyce

OBJECTIVE: It was hypothesized that increasing the time for which onabotulinum toxin A (OnabotA) is exposed to the urothelium following intravesical instillation will augment its effect. TC-3 is an inert heat-sensitive hydrogel, which creates an intravesical bulk providing a slow release of the embedded drug after instillation. The aim of this study was to evaluate the effect of OnabotA, embedded in inert TC-3 hydrogel, in patients with idiopathic overactive bladder (OAB). METHODS: In total, 39 female patients (age 30-65, average 53.8 years) with OAB symptoms were randomized for the study into four groups, each receiving 50 ml of the following intravesical instillations: Group A, 0.9% NaCl (placebo, n?=?11); Group B, TC-3 gel?+?200 U OnabotA (n?=?9); Group C, TC-3 gel?+?200 U OnabotA?+?dimethyl sulfoxide (DMSO) (n?=?10); and Group D, DMSO (n?=?9). The parameters were compared before and 1 month after treatment. RESULTS: When comparing parameters using conventional statistical methods (Kruskal-Wallis test), no statistically significant changes were observed within the groups. Comparison of the medians using an analysis based on the mathematical gnostics showed the superiority of the method used in Group B over the other groups in the following parameters: number of urgency grade 3?+?4 episodes/72 h, number of leakage episodes/72 h, Overactive Bladder Questionnaire total score and Patient Perception of Bladder Condition total score. Group D showed its superiority over the other groups in respect to the number of nocturia episodes/72 h. CONCLUSIONS: The results indicate that intravesical instillation of OnabotA, embedded in TC-3 gel, could become an alternative to intramural injection for a well-selected subgroup of patients.

Název v anglickém jazyce

Intravesical instillation of onabotulinum toxin A embedded in inert hydrogel in the treatment of idiopathic overactive bladder: A double-blind randomized pilot study

Popis výsledku anglicky

OBJECTIVE: It was hypothesized that increasing the time for which onabotulinum toxin A (OnabotA) is exposed to the urothelium following intravesical instillation will augment its effect. TC-3 is an inert heat-sensitive hydrogel, which creates an intravesical bulk providing a slow release of the embedded drug after instillation. The aim of this study was to evaluate the effect of OnabotA, embedded in inert TC-3 hydrogel, in patients with idiopathic overactive bladder (OAB). METHODS: In total, 39 female patients (age 30-65, average 53.8 years) with OAB symptoms were randomized for the study into four groups, each receiving 50 ml of the following intravesical instillations: Group A, 0.9% NaCl (placebo, n?=?11); Group B, TC-3 gel?+?200 U OnabotA (n?=?9); Group C, TC-3 gel?+?200 U OnabotA?+?dimethyl sulfoxide (DMSO) (n?=?10); and Group D, DMSO (n?=?9). The parameters were compared before and 1 month after treatment. RESULTS: When comparing parameters using conventional statistical methods (Kruskal-Wallis test), no statistically significant changes were observed within the groups. Comparison of the medians using an analysis based on the mathematical gnostics showed the superiority of the method used in Group B over the other groups in the following parameters: number of urgency grade 3?+?4 episodes/72 h, number of leakage episodes/72 h, Overactive Bladder Questionnaire total score and Patient Perception of Bladder Condition total score. Group D showed its superiority over the other groups in respect to the number of nocturia episodes/72 h. CONCLUSIONS: The results indicate that intravesical instillation of OnabotA, embedded in TC-3 gel, could become an alternative to intramural injection for a well-selected subgroup of patients.

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FP - Ostatní lékařské obory

OECD FORD obor

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Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2016

Kód důvěrnosti údajů

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

Název periodika

Scandinavian journal of urology

ISSN

2168-1805

e-ISSN

—

Svazek periodika

50

Číslo periodika v rámci svazku

n. 3

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

6

Strana od-do

"p. 200-205"

Kód UT WoS článku

000375039800012

EID výsledku v databázi Scopus

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