Artigo Revisado por pares

Efficacy of Botulinum Toxin A Injection for Neurogenic Detrusor Overactivity and Urinary Incontinence: A Randomized, Double-Blind Trial

2011; Lippincott Williams & Wilkins; Volume: 185; Issue: 6 Linguagem: Inglês

10.1016/j.juro.2011.02.004

ISSN

1527-3792

Autores

Sender Herschorn, Jerzy B. Gajewski, Karen Ethans, Jacques Corcos, Kevin Carlson, G Bailly, Robert Bard, Luc Valiquette, Richard Baverstock, Lesley K. Carr, Sidney B. Radomski,

Tópico(s)

Genital Health and Disease

Resumo

No AccessJournal of UrologyAdult Urology1 Jun 2011Efficacy of Botulinum Toxin A Injection for Neurogenic Detrusor Overactivity and Urinary Incontinence: A Randomized, Double-Blind Trial Sender Herschorn, Jerzy Gajewski, Karen Ethans, Jacques Corcos, Kevin Carlson, Gregory Bailly, Robert Bard, Luc Valiquette, Richard Baverstock, Lesley Carr, and Sidney Radomski Sender HerschornSender Herschorn University of Toronto, Toronto, Ontario, Canada Financial interest and/or other relationship with Astellas, Allergan, Pfizer, Johnson&Johnson, Contura and Coloplast. More articles by this author , Jerzy GajewskiJerzy Gajewski Dalhousie University, Halifax, Nova Scotia, Canada Financial interest and/or other relationship with Astellas, Allergan, Medtronic, Lilly and Pfizer. More articles by this author , Karen EthansKaren Ethans University of Manitoba, Winnipeg, Manitoba, Canada More articles by this author , Jacques CorcosJacques Corcos McGill University, Montreal, Quebec, Canada Financial interest and/or other relationship with Johnson&Johnson, Coloplast and Paladin. More articles by this author , Kevin CarlsonKevin Carlson University of Calgary, Calgary, Alberta, Canada Financial interest and/or other relationship with Health Education Limited Partnership, BR Capital, GlaxoSmithKline, Astellas and Pfizer. More articles by this author , Gregory BaillyGregory Bailly Dalhousie University, Halifax, Nova Scotia, Canada More articles by this author , Robert BardRobert Bard University of Manitoba, Winnipeg, Manitoba, Canada University of Calgary, Calgary, Alberta, Canada More articles by this author , Luc ValiquetteLuc Valiquette University of Montreal, Montreal, Quebec, Canada Financial interest and/or other relationship with Allergan, Astellas, Eli Lilly, GlaxoSmithKline, Pfizer, Cook and Olympus. More articles by this author , Richard BaverstockRichard Baverstock University of Manitoba, Winnipeg, Manitoba, Canada Financial interest and/or other relationship with Astellas, Pfizer and GlaxoSmithKline. More articles by this author , Lesley CarrLesley Carr University of Toronto, Toronto, Ontario, Canada Financial interest and/or other relationship with Cook Myosite, Astellas, Allergan and Pfizer. More articles by this author , and Sidney RadomskiSidney Radomski University of Toronto, Toronto, Ontario, Canada Financial interest and/or other relationship with Allergan, Pfizer, Lilly and Astellas. More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2011.02.004AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: We determined the efficacy of onabotulinumtoxinA for neurogenic detrusor overactivity secondary to spinal cord injury or multiple sclerosis. Materials and Methods: In a prospective, double-blind, multicenter study 57 patients 18 to 75 years old with neurogenic detrusor overactivity secondary to spinal cord injury or multiple sclerosis and urinary incontinence (defined as 1 or more occurrences daily) despite current antimuscarinic treatment were randomized to onabotulinumtoxinA 300 U (28) or placebo (29) via cystoscopic injection at 30 intradetrusor sites, sparing the trigone. Patients were offered open label onabotulinumtoxinA 300 U at week 36 and followed a further 6 months while 24 each in the treatment and placebo groups received open label therapy. The primary efficacy parameter was daily urinary incontinence frequency on 3-day voiding diary at week 6. Secondary parameters were changes in the International Consultation on Incontinence Questionnaire and the urinary incontinence quality of life scale at week 6. Diary and quality of life evaluations were also done after open label treatment. Results: The mean daily frequency of urinary incontinence episodes was significantly lower for onabotulinumtoxinA than for placebo at week 6 (1.31 vs 4.76, p <0.0001), and for weeks 24 and 36. Improved urodynamic and quality of life parameters for treatment vs placebo were evident at week 6 and persisted to weeks 24 to 36. The most common adverse event in each group was urinary tract infection. Conclusions: In adults with antimuscarinic refractory neurogenic detrusor overactivity and multiple sclerosis onabotulinumtoxinA is well tolerated and provides clinically beneficial improvement for up to 9 months. References 1 : Urinary incontinence in spinal cord injured individuals 10–45 years after injury. Spinal Cord2010; 48: 27. Google Scholar 2 : Urinary, faecal and sexual dysfunction in patients with multiple sclerosis. J Neurol1999; 246: 1027. Google Scholar 3 : Long-term medical complications after traumatic spinal cord injury: a regional model systems analysis. Arch Phys Med Rehabil1999; 80: 1402. Google Scholar 4 : Urinary dysfunction in multiple sclerosis. J Clin Neurosci2009; 16: 1321. Google Scholar 5 : Prevalence of bladder, bowel and sexual problems among multiple sclerosis patients two to five years after diagnosis. Mult Scler2007; 13: 106. Google Scholar 6 : EAU guidelines on neurogenic lower urinary tract dysfunction. Eur Urol2009; 56: 81. Google Scholar 7 : Antimuscarinics for treatment of overactive bladder. Lancet Neurol2004; 3: 46. Google Scholar 8 : Botulinum-A toxin for treating detrusor hyperreflexia in spinal cord injured patients: a new alternative to anticholinergic drugs?: Preliminary results . J Urol2000; 164: 692. Link, Google Scholar 9 : European experience of 200 cases treated with botulinum-A toxin injections into the detrusor muscle for urinary incontinence due to neurogenic detrusor overactivity. Eur Urol2004; 45: 510. Google Scholar 10 : Botulinum A toxin injections into the detrusor: an effective treatment in idiopathic and neurogenic detrusor overactivity?. Neurourol Urodyn2005; 24: 231. Google Scholar 11 : Botulinum toxin type A injections for treating neurogenic detrusor overactivity combined with low-compliance bladder in patients with spinal cord lesions. Arch Phys Med Rehabil2005; 86: 2114. Google Scholar 12 : Efficacy of botulinum-A toxin in adults with neurogenic overactive bladder: initial results. Can J Urol2005; 12: 2543. Google Scholar 13 : A comparison between the response of patients with idiopathic detrusor overactivity and neurogenic detrusor overactivity to the first intradetrusor injection of botulinum-A toxin. J Urol2005; 174: 984. Link, Google Scholar 14 : Treatment of neurogenic detrusor overactivity with botulinum toxin A: the first seven years. Urol Int2009; 83: 379. Google Scholar 15 : Botulinum toxin type A for neurogenic detrusor overactivity due to spinal cord lesions in children: a retrospective study of seven cases. J Pediatr Urol2009; 5: 430. Google Scholar 16 : Treatment outcomes and resource use of patients with neurogenic detrusor overactivity receiving botulinum toxin A (BOTOX) therapy in Germany. World J Urol2010; 28: 385. Google Scholar 17 : New therapeutic options for refractory neurogenic detrusor overactivity. Minerva Urol Nefrol2004; 56: 79. Google Scholar 18 : Intravesical resiniferatoxin versus botulinum-A toxin injections for neurogenic detrusor overactivity: a prospective randomized study. J Urol2004; 172: 240. Link, Google Scholar 19 : Botulinum toxin type a is a safe and effective treatment for neurogenic urinary incontinence: results of a single treatment, randomized, placebo controlled 6-month study. J Urol2005; 174: 196. Link, Google Scholar 20 : Efficacy and impact of botulinum toxin A on quality of life in patients with neurogenic detrusor overactivity: a randomised, placebo-controlled, double-blind study. Scand J Urol Nephrol2007; 41: 335. Google Scholar 21 : The standardization of terminology in neurogenic lower urinary tract dysfunction: with suggestions for diagnostic procedures: International Continence Society Standardization Committee . Neurourol Urodyn1999; 18: 139. Google Scholar 22 : ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn2004; 23: 322. Google Scholar 23 : Quality of life of persons with urinary incontinence: development of a new measure. Urology1996; 47: 67. Crossref, Medline, Google Scholar 24 : The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn2002; 21: 167. Google Scholar 25 : Botulinum toxin A improves the quality of life of patients with neurogenic urinary incontinence. Eur Urol2007; 52: 850. Google Scholar 26 : Reliability and validity of the Incontinence Quality of Life questionnaire in patients with neurogenic urinary incontinence. Arch Phys Med Rehabil2007; 88: 646. Google Scholar 27 : Outcome measures for research in adult women with symptoms of lower urinary tract dysfunction. Neurourol Urodyn1998; 17: 255. Google Scholar 28 : Outcome measures for research in treatment of adult males with symptoms of lower urinary tract dysfunction. Neurourol Urodyn1998; 17: 263. Google Scholar 29 : Noninvasive outcome measures of urinary incontinence and lower urinary tract symptoms: a multicenter study of micturition diary and pad tests. J Urol2000; 164: 698. Link, Google Scholar 30 : Systematic review and evaluation of methods of assessing urinary incontinence. Health Technol Assess2006; 10: 1. Google Scholar © 2011 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited byTipton W, de Riese W and de Riese C (2020) Review of New Implantable Tibial Nerve Stimulators in Comparison to Established Third Line Treatment Modalities for Nonneurogenic Overactive BladderUrology Practice, VOL. 7, NO. 6, (530-537), Online publication date: 1-Nov-2020.Wein A (2019) Re: Switch to Abobotulinum Toxin A May be Useful in the Treatment of Neurogenic Detrusor Overactivity when Intradetrusor Injections of Onabotulinum Toxin A FailedJournal of Urology, VOL. 201, NO. 3, (451-452), Online publication date: 1-Mar-2019.Clemens J (2012) ConJournal of Urology, VOL. 187, NO. 6, (1963-1965), Online publication date: 1-Jun-2012. Volume 185Issue 6June 2011Page: 2229-2235 Advertisement Copyright & Permissions© 2011 by American Urological Association Education and Research, Inc.Keywordsbotulinum toxin type Aurinary bladderspinal cord injuriesurinary incontinencemultiple sclerosisneurogenicAcknowledgmentsRandomization, monitoring, and data collection and analysis were done at Ethica Clinical Research. Sushma Soni, inScience Communications, and Dr. Sonja Dhani, Allergan, assisted with the manuscript.Metrics Author Information Sender Herschorn University of Toronto, Toronto, Ontario, Canada Financial interest and/or other relationship with Astellas, Allergan, Pfizer, Johnson&Johnson, Contura and Coloplast. More articles by this author Jerzy Gajewski Dalhousie University, Halifax, Nova Scotia, Canada Financial interest and/or other relationship with Astellas, Allergan, Medtronic, Lilly and Pfizer. More articles by this author Karen Ethans University of Manitoba, Winnipeg, Manitoba, Canada More articles by this author Jacques Corcos McGill University, Montreal, Quebec, Canada Financial interest and/or other relationship with Johnson&Johnson, Coloplast and Paladin. More articles by this author Kevin Carlson University of Calgary, Calgary, Alberta, Canada Financial interest and/or other relationship with Health Education Limited Partnership, BR Capital, GlaxoSmithKline, Astellas and Pfizer. More articles by this author Gregory Bailly Dalhousie University, Halifax, Nova Scotia, Canada More articles by this author Robert Bard University of Manitoba, Winnipeg, Manitoba, Canada University of Calgary, Calgary, Alberta, Canada More articles by this author Luc Valiquette University of Montreal, Montreal, Quebec, Canada Financial interest and/or other relationship with Allergan, Astellas, Eli Lilly, GlaxoSmithKline, Pfizer, Cook and Olympus. More articles by this author Richard Baverstock University of Manitoba, Winnipeg, Manitoba, Canada Financial interest and/or other relationship with Astellas, Pfizer and GlaxoSmithKline. More articles by this author Lesley Carr University of Toronto, Toronto, Ontario, Canada Financial interest and/or other relationship with Cook Myosite, Astellas, Allergan and Pfizer. More articles by this author Sidney Radomski University of Toronto, Toronto, Ontario, Canada Financial interest and/or other relationship with Allergan, Pfizer, Lilly and Astellas. More articles by this author Expand All Advertisement PDF downloadLoading ...

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