Efficacy and Safety of OnabotulinumtoxinA in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity: A Randomised, Double-Blind, Placebo-Controlled Trial

doi:10.1016/J.EURURO.2011.07.002

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Efficacy and Safety of OnabotulinumtoxinA in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity: A Randomised, Double-Blind, Placebo-Controlled Trial

Journal Article•DOI•

Efficacy and Safety of OnabotulinumtoxinA in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity: A Randomised, Double-Blind, Placebo-Controlled Trial

Francisco Cruz¹, Sender Herschorn², Philip Aliotta, Mitchell F. Brin³, Mitchell F. Brin⁴, Catherine Thompson³, Wayne Lam³, Grace Daniell³, John Heesakkers⁵, Cornelia Haag-Molkenteller³ - Show less +6 more•Institutions (5)

University of Porto¹, University of Toronto², Allergan³, University of California, Irvine⁴, Radboud University Nijmegen Medical Centre⁵

01 Oct 2011-European Urology (Elsevier)-Vol. 60, Iss: 4, pp 742-750

TL;DR: OnabotulinumtoxinA significantly reduced UI and improved urodynamics and QOL in MS and SCI patients with NDO in a multicentre, randomised, double-blind, placebo-controlled study.

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About: This article is published in European Urology.The article was published on 2011-10-01. It has received 422 citations till now. The article focuses on the topics: Urinary incontinence.

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Journal Article•DOI•

Summary of European Association of Urology (EAU) Guidelines on Neuro-Urology

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Jan Groen¹, Jürgen Pannek, David Castro Diaz², Giulio Del Popolo, Tobias Gross³, Rizwan Hamid, Gilles Karsenty⁴, Thomas M. Kessler⁵, Marc P. Schneider⁵, Lisette A. ‘t Hoen¹, Bertil F.M. Blok¹ - Show less +7 more•Institutions (5)

Erasmus University Rotterdam¹, University of La Laguna², University of Bern³, Aix-Marseille University⁴, University of Zurich⁵

01 Feb 2016-European Urology

TL;DR: The update of the EAU Guidelines on Neuro-Urology enables caregivers to provide optimal support to neuro-urological patients.

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401 citations

Cites background from "Efficacy and Safety of Onabotulinum..."

...Possible pathological findings include detrusor underactivity or acontractility, detrusor sphincter dyssynergia, a high urethral resistance, and PVR. Electromyography is useful as a gross indication of the patient’s ability to control the pelvic floor....
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...The most occurring side effects are UTIs and elevated PVR [32,33]....
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...Alphablockers seem to be effective for decreasing bladder outlet resistance, PVR, and autonomic dysreflexia [29]....
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...Possible pathological findings include a low maximum flow rate, low voided volumes, intermittent flow, and PVR. 3.3.7.3....
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...OnabotulinumtoxinA has been proven effective in patients with neurourological disorders in phase III randomized placebocontrolled trials [32,33]....
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Journal Article•DOI•

Lower urinary tract dysfunction in the neurological patient: clinical assessment and management

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Jalesh N. Panicker¹, Clare J. Fowler¹, Thomas M. Kessler²•Institutions (2)

UCL Institute of Neurology¹, University of Zurich²

01 Jul 2015-Lancet Neurology

TL;DR: An individualised, patient-tailored approach is required for the management of LUT dysfunction associated with neurological disorders, and neuromodulation offers promise for managing both storage and voiding dysfunction.

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Abstract: Lower urinary tract (LUT) dysfunction is a common sequela of neurological disease, resulting in symptoms that have a pronounced effect on quality of life. The site and nature of the neurological lesion affect the pattern of dysfunction. The risk of developing upper urinary tract damage and renal failure is much lower in patients with slowly progressive non-traumatic neurological disorders than in those with spinal cord injury or spina bifida; this difference in morbidity is taken into account in the development of appropriate management algorithms. Clinical assessment might include tests such as uroflowmetry, post-void residual volume measurement, renal ultrasound, (video-)urodynamics, neurophysiology, and urethrocystoscopy, depending on the indication. Incomplete bladder emptying is most often managed by intermittent catheterisation, and storage dysfunction by antimuscarinic drugs. Intradetrusor injections of onabotulinumtoxinA have transformed the management of neurogenic detrusor overactivity. Neuromodulation offers promise for managing both storage and voiding dysfunction. An individualised, patient-tailored approach is required for the management of LUT dysfunction associated with neurological disorders.

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318 citations

Journal Article•DOI•

Phase 3 Efficacy and Tolerability Study of OnabotulinumtoxinA for Urinary Incontinence From Neurogenic Detrusor Overactivity

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David A. Ginsberg¹, Angelo E. Gousse², V. Keppenne³, Karl-Dietrich Sievert⁴, Catherine Thompson⁵, Wayne Lam⁵, Mitchell F. Brin⁶, Brenda Jenkins⁵, Cornelia Haag-Molkenteller⁵ - Show less +5 more•Institutions (6)

University of Southern California¹, FIU Herbert Wertheim College of Medicine², University of Liège³, University of Tübingen⁴, Allergan⁵, University of California, Irvine⁶

01 Jun 2012-The Journal of Urology

TL;DR: OnabotulinumtoxinA significantly improved neurogenic detrusor overactivity symptoms vs placebo and no clinically relevant benefit in efficacy or duration was identified for the 300 U dose over the 200 U dose.

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307 citations

Journal Article•DOI•

Treatment of progressive multiple sclerosis: what works, what does not, and what is needed

[...]

Anthony Feinstein¹, Jenny Freeman², Albert C. Lo³•Institutions (3)

Sunnybrook Health Sciences Centre¹, University of Plymouth², Brown University³

01 Feb 2015-Lancet Neurology

TL;DR: A new strategy that can be used in future rehabilitation trials is needed, with the adoption of approaches that look beyond single interventions to concurrent, potentially synergistic, treatments that maximise what remains of neural plasticity in patients with progressive multiple sclerosis.

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Abstract: Disease-modifying drugs have mostly failed as treatments for progressive multiple sclerosis. Management of the disease therefore solely aims to minimise symptoms and, if possible, improve function. The degree to which this approach is based on empirical data derived from studies of progressive disease or whether treatment decisions are based on what is known about relapsing-remitting disease remains unclear. Symptoms rated as important by patients with multiple sclerosis include balance and mobility impairments, weakness, reduced cardiovascular fitness, ataxia, fatigue, bladder dysfunction, spasticity, pain, cognitive deficits, depression, and pseudobulbar affect; a comprehensive literature search shows a notable paucity of studies devoted solely to these symptoms in progressive multiple sclerosis, which translates to few proven therapeutic options in the clinic. A new strategy that can be used in future rehabilitation trials is therefore needed, with the adoption of approaches that look beyond single interventions to concurrent, potentially synergistic, treatments that maximise what remains of neural plasticity in patients with progressive multiple sclerosis.

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206 citations

Journal Article•DOI•

Neurogenic bladder in spinal cord injury patients.

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Waleed Al Taweel, Raouf M. Seyam

10 Jun 2015-Research and Reports in Urology

TL;DR: The current literature pertaining to the pathology and management of neurogenic bladder dysfunction in patients with spinal cord injury is summarized.

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Abstract: Neurogenic bladder dysfunction due to spinal cord injury poses a significant threat to the well-being of patients. Incontinence, renal impairment, urinary tract infection, stones, and poor quality of life are some complications of this condition. The majority of patients will require management to ensure low pressure reservoir function of the bladder, complete emptying, and dryness. Management typically begins with anticholinergic medications and clean intermittent catheterization. Patients who fail this treatment because of inefficacy or intolerability are candidates for a spectrum of more invasive procedures. Endoscopic managements to relieve the bladder outlet resistance include sphincterotomy, botulinum toxin injection, and stent insertion. In contrast, patients with incompetent sphincters are candidates for transobturator tape insertion, sling surgery, or artificial sphincter implantation. Coordinated bladder emptying is possible with neuromodulation in selected patients. Bladder augmentation, usually with an intestinal segment, and urinary diversion are the last resort. Tissue engineering is promising in experimental settings; however, its role in clinical bladder management is still evolving. In this review, we summarize the current literature pertaining to the pathology and management of neurogenic bladder dysfunction in patients with spinal cord injury.

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176 citations

Cites background from "Efficacy and Safety of Onabotulinum..."

...However, adverse events related to antibiotic treatment and emergence of drug Research and Reports in Urology 2015:7 submit your manuscript | www.dovepress.com Dovepress Dovepress 87 Neurogenic bladder in spinal cord injury resistance were common and limit the usefulness of this treatment regimen.15 Another prospective study in patients with SCIneurogenic bladder dysfunction conducted during initial management with CIC found that prophylactic antibiotics significantly reduced bacteriuria but not clinical UTIs.16 A meta-analysis examined the benefits and harms of antimicrobial prophylaxis for UTI in patients with SCI.17 The authors pooled the results from 15 clinical trials and reached the conclusion that there is no evidence to support the use of prophylactic antibiotics for most patients....
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...Prospective randomized studies have confirmed that treatment with botulinum toxin is associated with a significant reduction in urinary incontinence and improvements in urodynamic parameters and quality of life for patients with SCI.(71,73) No differences between doses of 200 units and 300 units were found in terms of tolerability, efficacy, or duration of effect....
[...]
...Prospective randomized studies have confirmed that treatment with botulinum toxin is associated with a significant reduction in urinary incontinence and improvements in urodynamic parameters and quality of life for patients with SCI.71,73 No differences between doses of 200 units and 300 units were found in terms of tolerability, efficacy, or duration of effect....
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References

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Open Access

More filters

Journal Article•DOI•

Rating neurologic impairment in multiple sclerosis An expanded disability status scale (EDSS)

[...]

John F. Kurtzke

01 Nov 1983-Neurology

TL;DR: A new Expanded Disability Status Scale (EDSS) is presented, with each of the former steps (1,2,3 … 9) now divided into two (1.0, 1.5, 2.0 … 9).

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Abstract: One method of evaluating the degree of neurologic impairment in MS has been the combination of grades (0 = normal to 5 or 6 = maximal impairment) within 8 Functional Systems (FS) and an overall Disability Status Scale (DSS) that had steps from 0 (normal) to 10 (death due to MS). A new Expanded Disability Status Scale (EDSS) is presented, with each of the former steps (1,2,3 . . . 9) now divided into two (1.0, 1.5, 2.0 . . . 9.5). The lower portion is obligatorily defined by Functional System grades. The FS are Pyramidal, Cerebellar, Brain Stem, Sensory, Bowel & Bladder, Visual, Cerebral, and Other; the Sensory and Bowel & Bladder Systems have been revised. Patterns of FS and relations of FS by type and grade to the DSS are demonstrated.

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13,564 citations

Journal Article•DOI•

Prognostic Value of Urodynamic Testing in Myelodysplastic Patients

[...]

Edward J. McGuire¹, Edward J. McGuire², Jeffrey R. Woodside², Jeffrey R. Woodside¹, Thomas A. Borden², Thomas A. Borden¹, Robert M. Weiss², Robert M. Weiss¹ - Show less +4 more•Institutions (2)

University of New Mexico¹, Yale University²

01 Aug 1981-The Journal of Urology

TL;DR: Assessment of urethral function showed 36 patients (86 per cent) with an open vesical outlet and nonfunctional proximal urethra and 7 of 42 patients had reflex detrusor activity: 4 with coordinated micturition and 3 withdetrusor-sphincter dyssynergia.

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958 citations

Journal Article•DOI•

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.

[...]

Brigitte Schurch¹, Marianne de Sèze¹, Pierre Denys¹, Emmanuel Chartier-Kastler¹, François Haab¹, Karel Everaert¹, Pierre Plante¹, Brigitte Perrouin-Verbe¹, Catherine Kumar¹, S Fraczek¹, Mitchell F. Brin¹ - Show less +7 more•Institutions (1)

University of California, Irvine¹

01 Jul 2005-The Journal of Urology

TL;DR: Intramuscular injections of BTX-A into the detrusor can provide rapid, well tolerated, clinically significant decreases in the signs and symptoms of urinary incontinence caused by neurogenicdetrusor overactivity during a 24-week study period.

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550 citations

"Efficacy and Safety of Onabotulinum..." refers background or result in this paper

...efficacy results observed in this study are consistent with previous onabotulinumtoxinA studies, most of which used 300 U [2,8,9,18,19]....
[...]
...injections (1 ml each) approximately 1 cm apart and to a depth of 2 mm, sparing the trigone [9]....
[...]
...) have been shown to improve clinical and urodynamic parameters and QOL in refractory NDO patients in several open-label studies (primarily at a dose of 300 U) [7,8] and in a small phase 2 placebo-controlled trial [9]....
[...]
...However, efficacy across multiple repeated injections is suggested in the published literature [8,9]....
[...]

Journal Article•DOI•

EAU Guidelines on Neurogenic Lower Urinary Tract Dysfunction

[...]

Manfred Stöhrer, Bertil F.M. Blok¹, David Castro-Diaz², E. Chartier-Kastler, Giulio Del Popolo, G. Kramer, Jürgen Pannek, Piotr Radziszewski³, Jean-Jacques Wyndaele⁴ - Show less +5 more•Institutions (4)

Erasmus University Rotterdam¹, Hospital Universitario de Canarias², Medical University of Warsaw³, University of Antwerp⁴

01 Jul 2009-European Urology

TL;DR: The diagnosis and treatment of NLUTD, which is a highly specialised and complex field involving both urology and medicine, requires up-to-date expert advice to be readily available and the current guidelines are designed to fulfil this need.

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528 citations

"Efficacy and Safety of Onabotulinum..." refers background in this paper

...The primary goals of treatment for NDO are to protect the upper urinary tract by decreasing bladder pressure, reducing incontinence, and improving QOL [12]....
[...]

Book•

Therapy with botulinum toxin

[...]

Joseph Jankovic, Mark Hallett

01 Jan 1994

TL;DR: Basic Science The Site and Mechanism of Action of Botulinum Neurotoxin, Julie A. Lebeda, Dallas C. Hack, and Mary K. Gentry Evaluation of Captopril and Other Potential Therapeutic Compounds in AntagonizingBotulinum Toxin-Induced Muscle Paralysis.

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Abstract: Basic Science The Site and Mechanism of Action of Botulinum Neurotoxin, Julie A. Coffield, Robert V. Considine, and Lance L. Simpson Structures of Botulinum Neurotoxin, Its Functional Domains, and Perspectives on the Crystalline Type A Toxin, Bibhuti R. DasGupta Preparation and Characterization of Botulinum Toxin Type A for Human Treatment, Edward J. Schantz and Eric A. Johnson Theoretical Analyses of the Functional Regions of the Heavy Chain of Botulinum Neurotoxin, Frank J. Lebeda, Dallas C. Hack, and Mary K. Gentry Evaluation of Captopril and Other Potential Therapeutic Compounds in Antagonizing Botulinum Toxin-Induced Muscle Paralysis, Michael Adler, Sharad S. Deshpande, Robert E. Sheridan, and Frank J. Lebeda Botulinum Toxin Type B: Experimental and Clinical Experience, Elizabeth Moyer and Paulette E. Setler Production and Properties of Type F Toxin, Tomoko Shimizu and Genji Sakaguchi Immunogenicity of the Neurotoxins of Clostridium botulinum, Charles L. Hatheway and Carol Dang Systemic Effects of Botulinum Toxin, Dale J. Lange Pharmacology and Histology of the Therapeutic Application of Botulinum Toxin, Gary E. Borodic, Robert J. Ferrante, L. Bruce Pearce, and Kathy Alderson Assessment of the Biological Activity of Botulinum Toxin, Christopher M. Shaari and Ira Sanders Dystonia Dystonia, Stanley Fahn Botulinum Toxin for Blepharospasm, John S. Elston Acute and Chronic Effects of Botulinum Toxin in the Management of Blepharospasm, Jonathan J. Dutton Clinical Assessments of Patients with Cervical Dystonia, Earl S. Consky and Anthony E. Lang Anatomy and Neurophysiology of Neck Muscles, Richard M. Dubinsky Clinical Neurophysiology of Cervical Dystonia, Michael J. Aminoff and Richard K. Olney Experience with Botulinum Toxin in Cervical Dystonia, W. Poewe and Jorg Wissel Controlled Trials of Botulinum Toxin for Cervical Dystonia: A Critical Review, Paul Greene Electromyography-Assisted Botulinum Toxin Injections for Cervical Dystonia, Cynthia L. Comella Botulinum Toxin Treatment of Focal Hand Dystonia, Barbara Illowsky Karp and Mark Hallett Limb Dystonia: Treatment with Botulinum Toxin, Seth L. Pullman Clinical Experience with Botulinum Toxin F, Karen Rhew, Christy L. Ludlow, Barbara Illowsky Karp, and Mark Hallett Hemifacial Spasm Hemifacial Spasm: Evaluation and Management, with Emphasis on Botulinum Toxin Therapy, Gary E. Borodic Management on Hemifacial Spasm with Botulinum A Toxin, Albert W. Biglan and Sang-Jin Kim Botulinum Toxin for Facial-Oral-Mandibular Spasms and Bruxism, Alfredo Berardelli, Bruno Mercuri, and Alberto Priori Strabismus Clinical Use of Botulinum Toxin: Clinical Trials for Strabismus, Elbert H. Magoon Strabismus: Other Therapies, Oscar A. Cruz and John T. Flynn Management of Acute and Chronic VI Nerve Palsy, Arthur L. Rosenbaum Speech and Voice Disorders Clinical Aspects of Speech Motor Compromise, David B. Rosenfield Acoustic, Aerodynamic, and Videoendoscopic Assessment of Unilateral Thyroarytenoid Muscle Injection with Botulinum Toxin for Spasmodic Dysphonia, Gayle E. Woodson, Thomas Murry, Petra Zwirner, and Michael R. Swenson Oromandibular Dystonia: Treatment of 96 Patients with Botulinum Toxin Type A, Mitchell F. Brin, Andrew Blitzer, Susan Herman, and Celia Stewart Botulinum Toxin Injection for Adductor Spasmodic Dysphonia, Christy L. Ludlow, Karen Rhew, and Eric Anthony Nash The Evaluation and Management of Abductor Laryngeal Dysphonia, Andrew Blitzer and Mitchell F. Brin Indirect Laryngoscopic Approach for Injection of Botulinum Toxin in Spasmodic Dysphonia, Charles N. Ford Unilateral Injections of Botulinum Toxin in Spasmodic Dysphonia, Donald T. Donovan, Kenneth Schwartz, and Joseph Jankovic Responses of Stutterers and Vocal Tremor Patients to Treatment with Botulinum Toxin, Sheila V. Stager and Christy L. Ludlow Miscellaneous Disorders Treatment of Tremors with Botulinum Toxin, Joseph Jankovic Botulinum Toxin in the Treatment of Tics, Joseph Jankovic Botulinum Toxin: Potential Role in the Management of Cerebral Palsy During Childhood, L. Andrew Koman, James F. Mooney III, and Beth Paterson Smith Clinical Trials for Spasticity, Joseph King, Ching Tsui, and Christopher F. O'Brien Effects of Botulinum Toxin Type A on Detrusor-Sphincter Dyssynergia in Spinal Cord Injury Patients, Dennis D. Dykstra Botulinum Toxin in the Treatment of Gastrointestinal Disorders, Pankaj Jay Pasricha and Anthony N. Kalloo Botulinum Toxin for Spasms and Spasticity in the Lower Extremities, Reiner Benecke Botulinum Toxin Treatment of Palatal Tremor (Myoclonus), Gunther Deuschl, E. Lohle, Camilo Toro, Mark Hallett, and Robert S. Lebovics Botulinum Toxin in the Treatment of Glabellar Frown Lines and Other Facial Wrinkles, Alastair Carruthers and Jean D. A. Carruthers

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441 citations