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@article{1853548,
author = {Amarenco, G. and Sutorý, Martin and Zachoval, R. and Agarwal, M. and Del Popolo, G. and Tretter, R. and Compion, G. and De Ridder, D.},
article_location = {HOBOKEN},
article_number = {2},
doi = {http://dx.doi.org/10.1002/nau.22945},
keywords = {cystometry; incontinence quality-of-life (I-QoL); multiple sclerosis (MS); neurogenic detrusor overactivity (NDO); solifenacin; SONIC; spinal cord injury (SCI); urodynamic},
language = {eng},
issn = {0733-2467},
journal = {NEUROUROLOGY AND URODYNAMICS},
title = {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},
url = {https://onlinelibrary.wiley.com/doi/10.1002/nau.22945},
volume = {36},
year = {2017}
}
TY - JOUR
ID - 1853548
AU - Amarenco, G. - Sutorý, Martin - Zachoval, R. - Agarwal, M. - Del Popolo, G. - Tretter, R. - Compion, G. - De Ridder, D.
PY - 2017
TI - 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
JF - NEUROUROLOGY AND URODYNAMICS
VL - 36
IS - 2
SP - 414-421
EP - 414-421
PB - WILEY
SN - 07332467
KW - cystometry
KW - incontinence quality-of-life (I-QoL)
KW - multiple sclerosis (MS)
KW - neurogenic detrusor overactivity (NDO)
KW - solifenacin
KW - SONIC
KW - spinal cord injury (SCI)
KW - urodynamic
UR - https://onlinelibrary.wiley.com/doi/10.1002/nau.22945
N2 - 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. (C) 2015 Wiley Periodicals, Inc.
ER -
AMARENCO, G., Martin SUTORÝ, R. ZACHOVAL, M. AGARWAL, G. DEL POPOLO, R. TRETTER, G. COMPION and D. DE RIDDER. 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. \textit{NEUROUROLOGY AND URODYNAMICS}. HOBOKEN: WILEY, 2017, vol.~36, No~2, p.~414-421. ISSN~0733-2467. Available from: https://dx.doi.org/10.1002/nau.22945.
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