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
Language English Country United States Media print-electronic
Document type Journal Article, Randomized Controlled Trial
PubMed
26714009
DOI
10.1002/nau.22945
Knihovny.cz E-resources
- Keywords
- SONIC, cystometry, incontinence quality-of-life (I-QoL), multiple sclerosis (MS), neurogenic detrusor overactivity (NDO), solifenacin, spinal cord injury (SCI), urodynamic,
- MeSH
- Adult MeSH
- Double-Blind Method MeSH
- Urinary Bladder, Overactive drug therapy physiopathology MeSH
- Quality of Life MeSH
- Middle Aged MeSH
- Humans MeSH
- Young Adult MeSH
- Urinary Bladder, Neurogenic drug therapy physiopathology MeSH
- Aged MeSH
- Solifenacin Succinate administration & dosage adverse effects therapeutic use MeSH
- Urodynamics drug effects physiology MeSH
- Urological Agents administration & dosage adverse effects therapeutic use MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Young Adult MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- Solifenacin Succinate MeSH
- Urological Agents MeSH
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.
Astellas Pharma Europe Global Data Science Leiden The Netherlands
Cardiff University and University Hospital of Wales Cardiff United Kingdom
Department of Medical Affairs Formerly at Astellas Pharma Europe Chertsey United Kingdom
Department of Neuro Urology Careggi University Hospital Florence Italy
Department of Urology KU Leuven University Hospitals Leuven Leuven Belgium
Hôpital Tenon Service De Neuro Urologie Et D'Explorations Perineales Paris France
Thomayer Hospital and 1st and 3rd Faculty of Medicine Charles University Prague Czech Republic
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