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

Identifikátory výsledku

  • 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>

Alternativní jazyky

  • 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.

Klasifikace

  • Druh

    J<sub>x</sub> - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

  • CEP obor

    FP - Ostatní lékařské obory

  • OECD FORD obor

Návaznosti výsledku

  • Projekt

  • Návaznosti

    I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Ostatní

  • Rok uplatnění

    2016

  • Kód důvěrnosti údajů

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

Údaje specifické pro druh výsledku

  • 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