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Neurourol Urodyn. 2017 Feb;36(2):414-421. doi: 10.1002/nau.22945. Epub 2015 Dec 29.

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.

Author information

1
Hôpital Tenon, Service De Neuro-Urologie Et D'Explorations Perineales, Paris, France.
2
Urological Department of Traumatological Clinic, Traumatological Hospital, School of Medicine, Masaryk University, Brno, Czech Republic.
3
Thomayer Hospital and 1st and 3rd Faculty of Medicine, Charles University, Prague, Czech Republic.
4
Cardiff University and University Hospital of Wales, Cardiff, United Kingdom.
5
Department of Neuro-Urology, Careggi University Hospital, Florence, Italy.
6
Astellas Pharma Europe, Global Data Science, Leiden, The Netherlands.
7
Department of Medical Affairs, Formerly at Astellas Pharma Europe, Chertsey, United Kingdom.
8
Department of Urology, KU Leuven, University Hospitals Leuven, Leuven, Belgium.

Abstract

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 10 mg in patients with NDO due to MS or SCI. Patients (n = 189) were randomized to placebo or active treatment (solifenacin 5 mg, 10 mg 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 10 mg 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 10 mg 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 10 mg 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 10 mg improved urodynamic variables and QoL versus placebo and was well tolerated. Neurourol. Urodynam. 36:414-421, 2017. © 2015 Wiley Periodicals, Inc.

KEYWORDS:

SONIC; cystometry; incontinence quality-of-life (I-QoL); multiple sclerosis (MS); neurogenic detrusor overactivity (NDO); solifenacin; spinal cord injury (SCI); urodynamic

PMID:
26714009
DOI:
10.1002/nau.22945
[Indexed for MEDLINE]

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