Solifenacin Is Effective and Well Tolerated in Patients With Neurogenic Detrusor Overactivity: Results From the Double-Blind, Randomized, Active- and Placebo-Controlled SONIC Urodynamic Study

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F17%3A10362055" target="_blank" >RIV/00216208:11110/17:10362055 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11120/17:43915897 RIV/00064190:_____/17:N0000069 RIV/00216224:14110/17:00124601

Výsledek na webu

<a href="http://dx.doi.org/10.1002/nau.22945" target="_blank" >http://dx.doi.org/10.1002/nau.22945</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1002/nau.22945" target="_blank" >10.1002/nau.22945</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Solifenacin Is Effective and Well Tolerated in Patients With Neurogenic Detrusor Overactivity: Results From the Double-Blind, Randomized, Active- and Placebo-Controlled SONIC Urodynamic Study

Popis výsledku v původním jazyce

Aims: To investigate the effect on urodynamics of 4 weeks treatment with solifenacin succinate in patients with neurogenic detrusor overactivity ( NDO) due to multiple sclerosis ( MS) or spinal cord injury ( SCI). Methods: SONIC was a prospective, multicenter, double-blind, phase 3b/4 study investigating the efficacy and safety of solifenacin 10mg in patients with NDO due to MS or SCI. Patients ( n = 189) were randomized to placebo or active treatment ( solifenacin 5 mg, 10mg or oxybutynin hydrochloride 15 mg) for 4 weeks, after a 2-week, single-blind, placebo run-in period. The primary endpoint was change in maximum cystometric capacity ( MCC) from baseline to end of treatment. The primary analysis compared solifenacin 10mg versus placebo; all other comparisons were considered secondary. Secondary endpoints included changes in urodynamic parameters, patient-reported outcomes, and safety assessments. Results: In the primary analysis, solifenacin 10mg significantly improved mean change from baseline MCC versus placebo ( P&lt;0.001) and was associated with improvements in bladder volume at first contraction and at first leak as well as detrusor pressure at first leak. Similar results were obtained for oxybutynin versus placebo. Patient perception of bladder condition significantly improved with solifenacin 10mg versus placebo ( P = 0.041). There was a clear improvement in quality of life ( QoL) in the solifenacin arms versus placebo. The overall incidence of adverse events was low. Conclusions: In patients with NDO due to MS and SCI, 4 weeks of treatment with solifenacin 10mg improved urodynamic variables and QoL versus placebo and was well tolerated.

Název v anglickém jazyce

Solifenacin Is Effective and Well Tolerated in Patients With Neurogenic Detrusor Overactivity: Results From the Double-Blind, Randomized, Active- and Placebo-Controlled SONIC Urodynamic Study

Popis výsledku anglicky

Aims: To investigate the effect on urodynamics of 4 weeks treatment with solifenacin succinate in patients with neurogenic detrusor overactivity ( NDO) due to multiple sclerosis ( MS) or spinal cord injury ( SCI). Methods: SONIC was a prospective, multicenter, double-blind, phase 3b/4 study investigating the efficacy and safety of solifenacin 10mg in patients with NDO due to MS or SCI. Patients ( n = 189) were randomized to placebo or active treatment ( solifenacin 5 mg, 10mg or oxybutynin hydrochloride 15 mg) for 4 weeks, after a 2-week, single-blind, placebo run-in period. The primary endpoint was change in maximum cystometric capacity ( MCC) from baseline to end of treatment. The primary analysis compared solifenacin 10mg versus placebo; all other comparisons were considered secondary. Secondary endpoints included changes in urodynamic parameters, patient-reported outcomes, and safety assessments. Results: In the primary analysis, solifenacin 10mg significantly improved mean change from baseline MCC versus placebo ( P&lt;0.001) and was associated with improvements in bladder volume at first contraction and at first leak as well as detrusor pressure at first leak. Similar results were obtained for oxybutynin versus placebo. Patient perception of bladder condition significantly improved with solifenacin 10mg versus placebo ( P = 0.041). There was a clear improvement in quality of life ( QoL) in the solifenacin arms versus placebo. The overall incidence of adverse events was low. Conclusions: In patients with NDO due to MS and SCI, 4 weeks of treatment with solifenacin 10mg improved urodynamic variables and QoL versus placebo and was well tolerated.

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

2017

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

—

Svazek periodika

36

Číslo periodika v rámci svazku

2

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

8

Strana od-do

414-421

Kód UT WoS článku

000394667800032

EID výsledku v databázi Scopus

2-s2.0-84952837655