Low-dose onabotulinumtoxinA improves urinary symptoms in noncatheterizing patients with MS
| Autor: | Brenda Jenkins, Emmanuel Chartier-Kastler, Benjamin M. Brucker, Meryl Mandle, Alfred Kohan, Veronique Keppenne, Mark Tullman, Pierre Denys, Blair Egerdie, Jean Paul Nicandro |
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| Rok vydání: | 2018 |
| Předmět: |
Adult
Male Urologic Diseases medicine.medical_specialty Multiple Sclerosis Neurotoxins 030232 urology & nephrology Urology Urinary incontinence Placebo Article law.invention 03 medical and health sciences 0302 clinical medicine Double-Blind Method Randomized controlled trial Quality of life law medicine Humans Botulinum Toxins Type A Adverse effect Dose-Response Relationship Drug medicine.diagnostic_test Urinary retention business.industry Cystoscopy Middle Aged Europe Clinical trial Urodynamics Treatment Outcome North America Quality of Life Female Neurology (clinical) medicine.symptom business 030217 neurology & neurosurgery Follow-Up Studies |
| Zdroj: | Neurology |
| ISSN: | 1526-632X 0028-3878 |
| DOI: | 10.1212/wnl.0000000000005991 |
| Popis: | ObjectiveTo evaluate the efficacy and safety of onabotulinumtoxinA 100 U in noncatheterizing patients with multiple sclerosis (MS) with urinary incontinence (UI) due to neurogenic detrusor overactivity (NDO).MethodsIn this randomized, double-blind phase III study, patients received onabotulinumtoxinA 100 U (n = 66) or placebo (n = 78) as intradetrusor injections via cystoscopy. Assessments included changes from baseline in urinary symptoms, urodynamics, and Incontinence–Quality of Life (I-QOL) total score. Adverse events (AEs) were assessed, including initiation of clean intermittent catheterization (CIC) due to urinary retention.ResultsOnabotulinumtoxinA vs placebo significantly reduced UI at week 6 (−3.3 episodes/day vs −1.1 episodes/day, p < 0.001; primary endpoint). Significantly greater proportions of onabotulinumtoxinA-treated patients achieved 100% UI reduction (53.0% vs 10.3%, p < 0.001). Significant improvements in urodynamics (p < 0.01) were observed with onabotulinumtoxinA. Improvements in I-QOL score were significantly greater with onabotulinumtoxinA (40.4 vs 9.9, p < 0.001) and ≈3 times the minimally important difference (+11 points). The most common AE was urinary tract infection (25.8%). CIC rates were 15.2% for onabotulinumtoxinA and 2.6% for placebo.ConclusionIn noncatheterizing patients with MS, onabotulinumtoxinA 100 U significantly improved UI and quality of life with lower CIC rates than previously reported with onabotulinumtoxinA 200 U.ClinicalTrials.gov identifier:NCT01600716.Classification of evidenceThis study provides Class I evidence that compared with placebo, 100 U onabotulinumtoxinA intradetrusor injections significantly reduce UI and improve quality of life in noncatheterizing patients with MS and NDO. |
| Databáze: | OpenAIRE |
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