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    More news can be found in New Pathways Magazine, our bi-monthly publication, and also check daily at MSRC: Latest MS News.

    Botox® authorised in UK for urinary leakage in MS, spinal cord injury

    BotoxBotox(R) has been licensed by the Medicines and Healthcare Products Regulatory Agency (MHRA) for the management of urinary incontinence in adult patients with neurogenic detrusor overactivity (NDO) due to subcervical spinal cord injury (SCI) (traumatic or non-traumatic) or multiple sclerosis (MS), who are not adequately managed with anticholinergics.

    The marketing authorisation is specific for Allergan's botulinum toxin type A product and is a key milestone in bringing this innovative treatment to people living with MS or SCI who have urinary leakage, providing them with a long-term solution for bladder control. Indeed, recently published NICE Guidelines recommend the use of botulinum toxin type A to treat patients with MS or SCI who have symptoms of an overactive bladder and in whom oral treatments have been ineffective or poorly tolerated.

    Approximately 140,000 people in the UK are living with MS or SCI. Between 75-80% of people with MS and 60-80% of people with SCI will suffer from some degree of bladder dysfunction including urinary leakage which can be extremely distressing. Urinary leakage in patients with MS or SCI is frequently caused by a condition called neurogenic detrusor overactivity, which results in involuntary contractions of the bladder during the filling stage when the bladder should be relaxed. This overactivity can lead to urinary incontinence (uncontrolled urinary leakage). Current treatment options include oral medications that need to be taken daily.

    However, less than 30% of patients manage to stay on oral medication for longer than a period of 12 months. If oral medications fail to control the leakage, then patients may require surgical intervention. Targeted injections with Allergan's botulinum toxin type A product into the bladder muscle have been shown to reduce the involuntary contractions and increase bladder capacity. In turn, this reduces the number of urinary leakage episodes and may even stop leakage altogether in some patients.

    "Historically, the management of urinary incontinence due to NDO has relied on daily medications. However, many patients find that daily medications are difficult to adhere to and sometimes these medications have limited effect," said Professor Christopher Chapple, Urology Department, Royal Hallamshire Hospital, Sheffield NHS Trust and a key investigator in the neurogenic detrusor overactivity registration trials. "Now, Botox(R) injections, given every 8-10 months into the bladder means that I have a new and potentially life changing treatment solution to help my patients get this distressing condition under control. Being able to better control and manage bladder function can be life-changing for patients."

    Many people living with MS and SCI face long-term mobility issues, yet remain professionally and socially active. Urinary leakage can be a disabling and socially isolating condition. The condition is associated with significant quality of life and emotional well-being implications such as embarrassment, low self-esteem, depression and loss of independence. Other health implications of urinary incontinence include skin irritation and ulcers, kidney failure and recurrent urinary tract infections, which may lead to serious health consequences if the overactivity of the detrusor muscle is not treated.

    Many people who have neurological diseases and are suffering from urinary incontinence remain undiagnosed and untreated. Amy Bowen, Director of Service Development at the MS Trust, explained, "For many people with MS, urinary leakage is frequently seen as a taboo subject with patients often reluctant or too embarrassed to talk about the symptoms to anyone. As a result, many people with MS can feel distressed, socially isolated and that they lack of control over their condition. It is a really positive development that there is now an additional, effective treatment option to help manage this difficult problem. Hopefully, more people with MS who are struggling with urinary leakage will feel confident to discuss these symptoms with their MS specialists and find the treatment option that is right for them."

    Alex Rankin, Director of Services for ASPIRE also welcomed the announcement "Many people who have been paralysed by spinal cord injury have to learn new techniques to manage their bladder. Botox(R) injections could now help a person with Spinal Cord Injury have better control over when and where they empty their bladder. This independence will lead to a greatly improved quality of life."

    DIGNITY: The largest clinical trial program in neurogenic detrusor overactivity

    The DIGNITY programme was Allergan's phase III clinical program evaluating the safety and efficacy of Botox(R) as a treatment in patients suffering from urinary incontinence due to neurogenic detrusor overactivity. The program consisted of two pivotal trials involving nearly 700 patients with either spinal cord injury or multiple sclerosis who were not adequately managed with at least one anticholinergic therapy. Eligible patients needed to be willing to perform clean intermittent catheterisation (CIC) to remove urine from the body, if required.

    Patients were randomized to receive a physician-administered single treatment of placebo, or 200 or 300 Units of Botox(R) injected as one procedure into the detrusor muscle using a rigid or flexible cystoscope. Treatment was shown to be effective within 2 weeks and lasted for approximately 42 weeks (or 9 months).

    The results from the DIGNITY program showed there was a highly statistically significant and clinically relevant reduction in frequency of the most bothersome symptom, urinary incontinence (leakage), reported in Botox(R) treated patients compared to placebo.

    - 76% of patients treated with Allergan's botulinum toxin type A product had a statistically significant reduction in urinary wetting episodes (defined as greater than or equal to 50% reduction) by week 6

    - Patients treated with 200 Units of Allergan's botulinum toxin type A product experienced a statistically significant reduction in the number of wetting episodes from 32.4 episodes/week at baseline to only 12.4 episodes during week 6 (a reduction of 21.3 episodes). In contrast, patients treated with placebo had an average of 31.5 episodes/week at baseline which was reduced to 21.0 episodes during week 6 (a reduction of only 10.5 episodes) (p<0.001)

    - Nearly 40% of patients treated with 200 Units of Allergan's botulinum toxin type A product were completely dry during week 6 compared to just 9% of patients treated with placebo

    - Patients treated with Allergan's botulinum toxin type A product experienced statistically significant improvements in quality of life including less avoidance behaviour, less psychosocial impact and less embarrassment compared to those on the placebo treatment arm

    "Allergan is pleased that Botox(R) has received the marketing authorisation in the UK for the treatment of urinary incontinence in people living with multiple sclerosis or spinal cord injury," said Douglas Ingram, President of Allergan in Europe, Africa and the Middle East. "For people with spinal cord injury or multiple sclerosis, gaining effective control over their bladder and staying dry can be a significant step towards improving overall quality of life."

    Like all medicines, Allergan's botulinum toxin type A product can cause side effects, although not everybody gets them. In general, side effects occur within the first few days following injection. They usually last only for a short time, but they may last for several months and in rare cases, longer. Overall, Allergan's botulinum toxin type A product treatment was generally well-tolerated in the majority of patients in the phase III clinical trial program.

    The most common adverse reactions were mainly associated with the urinary tract and included urinary tract infections and the inability to empty the bladder (urinary retention) in patients who were not using a catheter to remove urine. Other side effects included difficulty in sleeping (insomnia), tiredness, constipation, muscle weakness or spasm, blood in the urine after the injection, bulge in the bladder wall (bladder diverticulum), problems with walking (gait disturbance), possible uncontrolled reflex reaction of the body (e.g. profuse sweating, throbbing headache or increase in pulse rate) around the time of the injection (autonomic dysreflexia) or falls.

    Source:Science 2.0 © 2012 ION Publications LLC (01/10/12)

    Botox reduces tremors in MS patients

    BotoxThe anti-wrinkle treatment Botox has shown promising results as a treatment for multiple sclerosis patients suffering from tremors.

    Treatment with little more Botox than that used for wrinkles significantly reduced patients' upper limb shaking, The Royal Melbourne Hospital study found.

    Botox, a toxin derived from the Clostridium botulinum germ, is a muscle-relaxing medication used by the cosmetics industry to smooth wrinkles but it also has a number of medical benefits.

    It has already proven effective for muscle stiffness experienced by multiple sclerosis (MS) patients and is also available as a treatment for stroke and cerebral palsy sufferers.

    Neurologist Dr Anneke Van Der Walt and her colleagues, including Dr Andrew Evans, tested Botox in 23 MS patients, with all the patients experiencing a reduction of about 40 per cent in the severity of their shaking.

    Writing and drawing abilities improved by about 30 per cent in most patients, Dr Van Der Walt said.

    Overall, patients experienced improvements across a range of everyday activities, she said.

    'Even though it is a small study the results are very significant,' Dr Van Der Walt said.

    'We feel that this gives us a platform now to test this in more patients.

    'Hopefully this will translate into a very significant treatment for patients with MS who have this shaking of the upper limbs,' she told reporters.

    Dr Van Der Walt said Botox could be injected every three to four months but the study found most patients only required it every six months.

    'Every person and their tremor is different and doses, and timing of the doses, need to be individualised,' she said.

    About two-thirds of MS patients suffer upper limb tremors.

    The main side effect of the Botox treatment is muscle weakness, which often dissipates after one to two weeks, Dr Van Der Walt said.

    Dr Evans said other conditions had been treated with Botox for 20 years and there were no long-term concerns about its side effects or toxicity.

    A patient in the trial, 62-year-old Anca Chernok, said the tremors she experienced forced her to stop working 12 years ago.

    She said the Botox treatments in her arms allowed her to care for herself.

    'To be self sufficient, to look after myself ...was a great gift,' she said.

    'I felt human again.'

    Another patient, Andrew White, 55, said the treatments had allowed him to continue working as a human relations manager and to help around the house.

    'My wife is delighted that I don't smash dishes anymore when I'm putting them in the dishwasher,' he joked.

    Both patients have continued receiving the injections outside of the trial.

    The treatment will be trialled among a larger number of patients next year.

    The study was published in the American Academy of Neurology journal, Neurology.

    Source: Sky News Australia Copyright Australian News Channel Pty Ltd (02/07/12)

    Positive top-line results from phase III BOTOX® overactive bladder program

    BotoxAllergan, Inc. announced that two Phase III clinical trials of BOTOX® (onabotulinumtoxinA) as a potential treatment option for patients with idiopathic overactive bladder met their pre-specified primary endpoints.

    Results from both Phase III clinical trials demonstrate that BOTOX® significantly reduced urinary incontinence (bladder leakage) episodes compared to placebo for the treatment of overactive bladder patients with urinary incontinence who were not adequately managed by an anticholinergic treatment.

    The summary data are being presented as part of Allergan’s Research and Development Technology Review, which will be held today at 1 p.m. Eastern Time. The full study results of the North American Phase III study are expected to be presented at an upcoming medical meeting.

    Based on the results of the two Phase III clinical trials, Allergan has submitted a supplemental biologics license application (sBLA) with the U.S. Food and Drug Administration (FDA) and an application with European Regulatory authorities seeking approval for the use of BOTOX® as treatment of overactive bladder with symptoms of urinary incontinence, urgency, and frequency, in adult patients who have an inadequate response to or are intolerant of an anticholinergic medication. BOTOX® is currently approved in the United States and in several European countries for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g., spinal cord injury (SCI), multiple sclerosis (MS)) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

    “Allergan is committed to the research and clinical development of novel treatment options for urologists and their patients, and we look forward to potentially expanding the use of BOTOX® as a treatment option following approval by the respective regulatory agencies,” said Scott Whitcup, M.D., Allergan’s Executive Vice President, Research and Development, Chief Scientific Officer. “We are pleased with the results of our idiopathic overactive bladder Phase III clinical trials, which demonstrated that BOTOX® treatment provided benefit to these overactive bladder patients with symptoms of urinary incontinence who failed or were intolerant of other therapy.”

    Overactive bladder (OAB) is a medical condition that results in an uncontrolled urge to void, frequent voids and, in many patients, uncontrolled urinary leakages. In most cases, the precise cause of OAB is unknown. An estimated 13 million adults in the United States experience urinary incontinence, or bladder leakage, as a symptom of OAB. An estimated 3.2 million Americans with OAB, with or without urinary incontinence, are taking oral medications known as anticholinergics, which is the current standard of care.(1) It is estimated, however, that greater than 50 percent of these patients discontinue oral medications, likely due to an inadequate response to, or intolerance of, the medication.(2,3,4)

    Both Phase III clinical trials included patients with symptoms of OAB not caused by a neurological condition who were suffering with urinary incontinence for at least six months and who were inadequately treated with an anticholinergic therapy. Patients were randomly assigned to treatment with BOTOX® or placebo injections into the detrusor (bladder) muscle, followed by an injection with BOTOX® after a minimum of 12 weeks if desired. In both studies, there was a highly statistically significant decrease in the number of daily incontinence episodes in patients treated with BOTOX® vs. placebo (p<0.001).

    In both Phase III clinical trials, BOTOX® treatments were well tolerated in patients suffering from OAB symptoms with urinary incontinence. Adverse events were primarily limited to the urinary tract, with urinary tract infection rates between 15-20 percent and urinary retention rates between 5-6 percent for patients treated with BOTOX® in both studies. Patients receiving BOTOX® treatments in both studies also reported an improvement in quality of life.

    About BOTOX® (onabotulinumtoxinA)

    BOTOX® is a prescription-only medical product that contains tiny amounts of highly purified botulinum toxin protein refined from the bacterium, Clostridium botulinum. BOTOX® has a unique, protected molecular structure that stabilizes the core toxin in BOTOX® from degradation. When injected at FDA-approved and labeled doses into a specific muscle or gland, BOTOX® neurotoxinis expected to diffuse locally and produce a safe and effective result by producing a localized and temporary reduction in the overacting muscle or gland, usually lasting up to approximately three to ten months depending on the indication and on the individual patient.

    BOTOX® was first approved by the FDA more than 22 years ago for the treatment of strabismus and blepharospasm, two eye muscle disorders, making it the first botulinum toxin type A product approved in the world. Since its first approval in 1989, BOTOX® has been recognized by regulatory authorities worldwide as an effective treatment for 25 different indications in approximately 85 countries, benefiting millions of patients worldwide. In the United States, BOTOX® neurotoxin is also approved to treat seven medical conditions, including the abnormal head position and neck pain that happens with cervical dystonia (CD) in adults; symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough; for the treatment of increased muscle stiffness in elbow, wrist, and finger muscles in adult patients with upper limb spasticity; for the prophylactic treatment of headaches in adults with Chronic Migraine, a distinct and severe neurological disorder characterized by patients who have a history of migraine and suffer from headaches on 15 or more days per month with headaches lasting four hours a day or longer; and most recently, for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g., spinal cord injury (SCI), multiple sclerosis (MS)) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

    In addition to its therapeutic uses, the same formulation of BOTOX® with dosing specific to moderate to severe glabellar lines was approved by the FDA in 2002 under the trade name BOTOX® Cosmetic (onabotulinumtoxinA). BOTOX® Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines (frown lines between the eyebrows) associated with corrugator and/or procerus muscle activity in adult patients up to 65 years of age.

    In addition to approximately 21 years of clinical experience, the safety and efficacy of BOTOX® have been well-established in approximately 65 randomized, placebo-controlled clinical trials and in approximately 15,000 patients treated with BOTOX® and BOTOX® Cosmetic in Allergan’s clinical trials.(5) Worldwide, approximately 30 million vials of BOTOX® and BOTOX® Cosmetic have been distributed and approximately 29 million treatment sessions have been performed over the past 20 years (1990-2010).(6) With approximately 2,500 articles on BOTOX® and BOTOX® Cosmetic in scientific and medical journals,(7) BOTOX® neurotoxin is one of the most widely researched medicines in the world.

    Source: MarketWatch Copyright © 2012 MarketWatch, Inc (30/03/12)

    Botox cuts MS-related arm tremors

    BotoxInjections of botulinum toxin A (Botox) were a significant help to multiple sclerosis patients whose disease causes arm tremors, according to a small study reported here.

    In a placebo-controlled crossover trial involving 25 patients, Botox injected into the affected muscles significantly improved the tremors, said Anneke van der Walt, MBChB, of Royal Melbourne Hospital in Australia.

    The treatment also allowed many of the patients to again perform simple activities such as handwriting and drinking from open cups that the tremors had made difficult or impossible, van der Walt told attendees at the joint meeting of the European and Americas Committees for Treatment and Research in Multiple Sclerosis.

    Currently there is no specific treatment for MS-related tremors, she explained. The present standard of care involves anticonvulsant drugs such as levetiracetam (Keppra) or carbamazepine, with a variety of other agents often used as well. These include benzodiazepines, beta-blockers, and even the anti-nausea drug ondansetron.

    Van der Walt described these medications as "unrewarding" and indicated that nonsurgical approaches such as thalamotomy and deep brain stimulation had substantial side effects and lacked confirmation of long-term efficacy.

    Botox, on the other hand, is considered safe when injected carefully and has been found helpful in a host of conditions involving abnormal muscle activity, ranging from overactive bladder to migraine.

    The 25 patients in the study included some with bilateral tremors, such that a total of 33 arms were treated and evaluated, after excluding one dropout and two patients who experienced MS relapse during the study. About three-quarters of participants had secondary progressive MS, with mean disease duration of 17 years (SD 8.5) and mean duration of tremor of 6.5 years (SD 5.1).

    The median of both EDSS disability score and Unified Dystonia Rating Scale score was 5.5.

    Patients received injections of botulinum toxin A or placebo targeted to their specific tremor patterns. A maximum of 100 IU of Botox was given in each injection.

    Evaluations were conducted at baseline and six and 12 weeks after the treatment. At that point, participants crossed over to the other treatment for an identical series of injections and assessments.

    The primary outcome measure was change from baseline in Bain scores for ability to hand-write a standard sentence, drawing of an Archimedes spiral, and a composite of tremor severity.

    A variety of other ratings were secondary outcomes. These included scores for postural, action, intention, and rest tremors as well as for abilities to perform ordinary tasks such as drawing straight lines, pouring liquids, and drinking from a cup.

    Videos were taken at baseline and at each post-treatment evaluation of participants performing these tasks.

    Van der Walt showed clips of one middle-age male patient who had major improvement following the toxin injections.

    At baseline, the man's left hand shook violently as he tried to write on a piece of paper and to hold a cup to his lips.

    The "after" video showed him successfully drawing the Archimedes spiral, pouring water into a container without spilling, and drinking from a cup. However, it wasn't a total cure, as his hand still shook noticeably during these activities.

    For all 33 arms included in the study, the mean decrease in Bain scores for tremor severity following the active Botox injections was about 2.0 at six and 12 weeks. The writing and drawing scores both declined by close to 1.0.

    Very slight increases in Bain scores for all three components were seen in the averages following placebo injections, van der Walt reported. P values for all comparisons between Botox and placebo were less than 0.001.

    Postural and action tremors both showed significantly greater improvement with Botox than with placebo at the six- and 12-week evaluations. However, resting and intentional tremors did not improve.

    Not all participants showed significant improvements in all functional tasks at both evaluations, though when statistical significance was lacking the trend was still strong.

    For example, improvements in ability to drink from a cup fell just short of significant at six weeks (P=0.069) but reached significance at 12 weeks (P=0.009). The opposite pattern was seen for pouring water into a container.

    The major adverse effect associated with toxin injections was weakness in the injected arm, van der Walt said. It was reported in 42% of Botox-treated arms versus 6% of those receiving placebo shots.

    None of the weakness was severe, she added; most was rated as moderate, defined as feeling weak but still able to use it.

    In all cases, moreover, the weakness did not last beyond two weeks after the injections.

    In response to an audience question, van der Walt said that many participants had continued to receive Botox injections in the hospital's outpatient clinic and there seemed to be no loss of effectiveness with repeated treatment. The weakness effect also appeared to decline with additional injections.

    Session co-moderator Jürg Kesselring, MD, of the Neuroscience Center in Zurich, Switzerland, complimented van der Walt on the research.

    "This is important because we are so desperate for something to offer our tremor patients," he said.

    The study was funded by the RMH Neuroscience Foundation and Box Hill MS Research Fund. Allergan provided Botox free of charge.

    Van der Walt reported grant funding and/or direct payments from Bayer, Biogen Idec, Merck Serono, and GlaxoSmithKline.

    Kesselring has served on trial oversight committees and/or advisory boards for Biogen, Novartis, Serono, Schering, and Wyeth.

    Primary source: ECTRIMS/ACTRIMS Triennial Meeting
    Source reference:
    van der Walt A, et al "Botulinum toxin type A for the treatment of disabling tremor in multiple sclerosis: a double-blind, randomised controlled study" ECTRIMS/ACTRIMS 2011; Abstract 50.

    Source: MedPage Today © 2011 Everyday Health, Inc.(21/10/11)

    Botox for bladders: wrinkle-smoother treats incontinence too

    BotoxBotox, a drug famous for smoothing out wrinkles, could make life a little easier for people with urinary incontinence. By paralyzing the muscular lining of the bladder, the drug decreases the urgency and frequency of urination.

    Botox maker Allergan has applied for Food and Drug Administration approval in people with multiple sclerosis and spinal cord injury whose conditions result in bladder overactivity.

    "Those people are very much affected by this," said Caroline Van Hove, Allergan's vice president of corporate affairs. "The conditions make the bladder muscle involuntarily contract, and that causes patients to have to go to the bathroom frequently and unexpectedly."

    Approval could come by the end of the year, potentially making urinary incontinence the eighth condition treated with Botox. Only one use is cosmetic; the other conditions include chronic migraine and spasticity.

    "The uses of Botox are increasing," said Van Hove, adding that medical indications currently account for roughly half of the drug's $1.4 billion in worldwide sales, the remainder coming from cosmetic uses. "With the new uses, definitely that 50-50 split will sway more towards therapeutic."

    There are other drugs that perform multiple roles, including a skin cancer cream used to smooth out your facial wrinkles, a baldness drug to protect against prostate cancer, and a drug for enlarged prostate and possibly prostate cancer that may stop baldness.

    Once a drug has been approved for one use, doctors can prescribe it "off-label" when it is shown to be useful for something else. And an increasing number of drugs are prescribed in this manner. Off-label use of medicines accounts for about one fifth of all prescriptions, according to a 2008 study in the New England Journal of Medicine.

    Many of these off-label uses meet with controversy and questions about their value, particularly since the FDA has not yet approved them. (As a result, drug companies cannot advertise off-label uses.) But in other cases, the alternative uses are well-known in the medical community -- though perhaps not among the general public -- and are regularly exploited.

    Source: ABC News Copyright 2011 ABC News Radio (08/08/11)

    BOTOX receives FDA approval for treatment of upper limb spasticity in adults
    Allergan LogoAllergan Inc. announced that the United States Food and Drug Administration or FDA has approved BOTOX for treatment of increased muscle stiffness in the elbow, wrist and fingers in adults with upper limb spasticity.

    Upper limb spasticity may occur following a spinal cord or traumatic brain injury or in patients affected by multiple sclerosis or adults with a history of cerebral palsy. FDA approved the drug to treat spasticity in flexor muscles, a condition that can result from stroke, brain injury or multiple sclerosis.

    Source: RTT News © 2010 RTTNews (10/03/10)

    Botulinum Toxin Type A Helps Multiple Sclerosis Patients With Spastic Foot Drop
    Botulinum toxin type A injections can decrease spasticity and improve quality of life in multiple sclerosis (MS) patients with spastic foot drop,

    Anjali Shah, MD, Assistant Professor, Divisions of Physical Medicine and Rehabilitation and Neurology, University of Texas Southwestern Medical Center, Dallas, Texas, and colleagues reported on data from 19 patients whose spastic foot drop was treated with botulinum toxin type A injections.

    Nearly 90% of MS patients report the presence of spasticity, and lower-extremity spasticity increases the energy of walking and aggravates fatigue, Dr. Shah pointed out. Oral antispasticity medications can exacerbate fatigue and decrease cognitive functioning.

    Botulinum toxin type A injections focally target spasticity, and do not cause fatigue; there are, however, limited data on the use of such injections to specifically treat spastic foot drop due to plantar flexor spasticity in MS patients.

    According to the study protocol, 150 units of botulinum toxin type A diluted in 1 cc of preservative-free saline were injected into the medial gastrocnaemius muscle, lateral gastrocnaemius muscle, and soleus muscle.

    Electrical stimulation was used to localise the motor points in the target muscles.

    Patients underwent 6 to 8 weeks of physical therapy.

    Overall, 74.7% of patients have returned for repeat botulinum toxin type A injections.

    Patient self-report surveys revealed improved ambulation with less tripping or toe drag, improved driving ability, and less fatigue.

    Results document significant improvement in spasticity (P = .1) and emotional quality of life (P = .035).

    Dr. Shah cautioned that the study was limited by small sample size and the use of varying physical-therapy programs between subjects.

    [Presentation title: Botulinum Toxin in the Treatment of Spastic Foot Drop in Multiple Sclerosis: An Analysis of the Effects on Gait, Fatigue and Quality of Life. Abstract P03.070]

    Source: Doctor's Guide (c) 1995-2008 Doctor's Guide Publishing Limited (18/04/08)

    Better Treatment for Bladder Problems in People With Multiple Sclerosis
    New research funded by the MS Society has shown that Botox injections to the bladder provide benefits for people with multiple sclerosis (MS) with sustained improvements to their overall quality of life.

    Bladder problems are a common and disabling symptom of MS where both storage and emptying processes can be disrupted. Incontinence is common and being unable to 'hold on' (known as urgency) is understandably considered by many people with MS to be one of the most troubling symptoms they face.

    In the recent research, carried out at the National Hospital for Neurology and Neurosurgery, 43 people with MS who had severe incontinence problems were treated with botulinum neurotoxin type A (Botox (R)) bladder muscle injections. The action of the injection on the bladder is complex but its overall effect is to reduce involuntary contractions and so reduce frequency of urination and urgency.

    The GBP200,000 study showed significant improvements in incontinence episodes and the frequency of urination both day and night. There were also sustained improvements in all quality of life measures used and frequency of urination returned to near normal.

    Dr Laura Bell, Research Communications Officer for the MS Society, said: "Living with symptoms such as bladder problems can be extremely distressing and restrictive, but this type of treatment can make a tangible and substantial improvement to people's lives and we hope it will become part of standard care for people with MS who need it."

    The typical duration of the effect of the treatment was 10 months and similar results were seen with repeat treatments.

    This treatment is not yet licensed in the UK and is consequently not yet widely available for people with MS.

    Professor Clare Fowler, Consultant in Uro-Neurology at The National Hospital for Neurology and Neurosurgery said: "This study was done as part of a research investigation and the treatment is not widely available. This is because bladder injections of Botox(R) have not yet been licensed and although studies by the pharmaceutical company are ongoing it will probably take a few more years.

    "This research has been extremely valuable in establishing a clinical method, researching why the treatment works so very well, and providing an opportunity to demonstrate the minimally invasive injection technique to more than 60 visitors, mostly UK consultant urologists, who attended as observers."

    Further clinical trials to ascertain its effect in people with MS are currently underway. More information about clinical trials can be found at 

    Source: MS Society (27/11/07)

    Botox® may help spinal cord-injured or multiple sclerosis patients with overactive bladder
    Botox® may help patients who suffer from spinal cord injuries and multiple sclerosis have better control of their overactive bladders, said a physician-scientist at Baylor College of Medicine in Houston.

    Dr. Christopher Smith, assistant professor of urology at BCM, said an international multi-center study using Botox® to treat these patients is currently ongoing. He will direct the BCM part of the study.

    "People with spinal cord injuries or multiple sclerosis are particularly prone to developing overactive bladder because the normal nerve pathways between the bladder and brain become interrupted," said Smith. "In these conditions, the bladder becomes overactive leading to urinary symptoms of frequency, urgency and possibly incontinence."

    Botox® is a commercial preparation of botulinum toxin A that works by preventing nerve impulses from reaching the muscle.

    "Botox® is the most potent drug known to man," said Smith. "It's amazing how medicine can utilize such an agent for therapeutic benefit. If you focally inject it in small quantities within the bladder, one can reduce overactive bladder symptoms without side effects associated with oral medications."

    Botox® is advantageous because it is a durable yet reversible treatment, with symptom relief lasting between six to 12 months.

    "Before Botox®, the only option left for a patient with refractory overactive bladder symptoms was to undergo extensive abdominal surgery, using the intestines to enlarge the bladder. This treatment requires a prolonged recovery period and, for the most part, is considered irreversible," said Smith. "Patients often prefer the reversible and less invasive option of Botox® injection."

    Past studies show the drug is effective, but results from treatment in more patients are needed.

    Source: Baylor College of Medicine © 1998 - 2007 Baylor College of Medicine® (15/09/07)

    Botox: Helping Patients Move Again
    The medication known for smoothing a wrinkled brow can also relieve uncontrollable muscle tightness that prevents many patients from functioning normally.

    Botulinum Toxin, commonly knows as Botox, can paralyse and kill if consumed in contaminated food. But it's now safely used, in a purified form, as a medicine to control certain conditions marked by involuntary muscle contractions. Spasticity: This is a condition that occurs after a stroke, in multiple sclerosis and cerebral palsy patients or those suffering from traumatic brain injuries. Muscles become overactive and tighten uncontrollably. These spasms cause pain and can prevent a person from moving normally.

    HOW IT WORKS: Once in the body, the toxin binds to nerve endings at the point where the nerves join muscles. This prevents the nerves from signaling the muscles to contract. The result is weakness and paralysis in that muscle. Botox is not approved by the FDA to treat spasticity, but doctors can prescribe the medication if they think it will be helpful.

    HOW LONG DOES IT LAST? The drug injections usually don't manifest symptoms of recovery until a few days after the injections. The effects are usually long-lasting, however, and depending on the amount and where it was injected; Botox therapy can last from four to eight months.

    SIDE EFFECTS: Botox therapy is a safe and effective treatment when given in very small amounts by a qualified neurologist. Some patients experience temporary weakness in the group of muscles being treated. Flu-like symptoms develop in some, but doctors say it is rare.

    Source: Copyright ©2007 ABC Inc., WLS-TV Chicago

    Botox could be used to treat incontinence and cystitis
    It has won an army of celebrity fans for banishing crow's feet and frown lines, but the use of Botox to combat bladder problems such as incontinence has been hailed as a 'major advance' by a urology expert.

    Christopher Chapple, a visiting professor at Sheffield Hallam University, said poisonous botulinum toxin could be used therapeutically to treat bladder storage and sensation problems such as incontinence and cystitis. Professor Chapple, who is carrying out new research into the treatment at the University's Biomedical Research Centre, said it had successfully helped eighty per cent of cases during recent trials.

    He explained in a lecture at Sheffield Hallam that a simple injection of the substance into the bladder lining could bring relief to some of the ten per cent of people in the UK who currently suffer from an overactive bladder, which is resistant to other drug therapy.

    He said: "Doctors are now realising the role of the bladder lining as the cause of problems to do with frequent or painful passing of urine. By injecting the patient's bladder lining with botulinum toxin, we can block the release of nerve transmitter substances and sensory nerves, which means that the patient doesn't feel the need to go to the toilet as often. It also means we don't have to rely on intensive drug therapy, or invasive surgery.

    "Around ten per cent of the current UK population has an overactive bladder, while nearly a third of us will experience bladder storage or sensation problems at some point in our lives.

    "The bladder normally stores urine at a low pressure, until it can be passed at a socially acceptable time, but some people have problems storing urine and need to go frequently, and urgently. Problems can occur with age, or sometimes as the result of a neurological disorder such as multiple sclerosis.

    "Imagine you've come home after a few drinks, you need to pee, and you're fumbling to get the key in the door - that's the sensation some of these people experience every day."

    He added: "Treatment with botulinum toxin has been successful in eighty per cent of cases so far. Work is still ongoing, but there is no doubt that it is a major advance that will really improve sufferers' quality of life."

    Botulinum toxin, commercially known as Botox, is highly toxic, but is used in minute doses to control muscle spasms. Demi Moore and Madonna have reportedly benefited from its cosmetic, wrinkle-softening effects.

    The simple bladder lining treatment lasts between three and six months, and can be administered to outpatients under local anesthetic.

    Around fifty people have currently been treated with the botulinum toxin treatment. Professor Chapple and his team are now involved in clinical trials, and will publish further findings at the end of the current, 18-month long research project.

    Professor Chapple has a specialist interest in reconstructive surgery and is also working on engineering tissue to carry out urethral reconstruction. Other research is ongoing in the research group to investigate the underlying problems behind bladder and prostate problems.

    Christopher Chapple is a Consultant Urological Surgeon at the Royal Hallamshire Hospital, part of Sheffield Teaching Hospitals NHS Trust.

    He spoke at Sheffield Hallam University on Wednesday 21 February, 2007.

    Source: News-Medical.Net©2007 News-Medical.Net (21/02/07)

    © Multiple Sclerosis Resource Centre (MSRC)

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