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
The result's identifiers
Result code in 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>
Alternative codes found
RIV/00216208:11120/17:43915897 RIV/00064190:_____/17:N0000069 RIV/00216224:14110/17:00124601
Result on the web
<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>
Alternative languages
Result language
angličtina
Original language name
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
Original language description
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<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.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30217 - Urology and nephrology
Result continuities
Project
—
Continuities
V - Vyzkumna aktivita podporovana z jinych verejnych zdroju
Others
Publication year
2017
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Neurourology and Urodynamics
ISSN
0733-2467
e-ISSN
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Volume of the periodical
36
Issue of the periodical within the volume
2
Country of publishing house
US - UNITED STATES
Number of pages
8
Pages from-to
414-421
UT code for WoS article
000394667800032
EID of the result in the Scopus database
2-s2.0-84952837655