The botulinum toxin, also known as Botox (onabotulinumtoxinA), is approved by the FDA to treat muscle spasms, spasticity, and bladder symptoms in patients with a wide range of diseases including multiple sclerosis (MS). The therapy is based on the bacteria Clostridium botulinum — a toxin that blocks neuromuscular conduction between the nerves and the muscles. The therapeutic result is a short-term localized relaxation of the targeted muscle.

Botox is manufactured by Allergan. The prescription medicine is injected into the muscles to treat increased muscle stiffness in ankle and toe muscles in adults with lower limb spasticity, and in elbow, wrist, finger, and thumb muscles in adults with upper limb spasticity.

There are no studies yet that confirm Botox’s safety and effectiveness for treating upper limb muscles other than those in the elbow, wrist, and thumb, or to treat increased stiffness in lower limb muscles other than ankle and toes.

Botox is injected approximately once every three months directly into the affected muscles by a healthcare specialist. The treatment can be repeated once the effect has worn off, but no sooner than three months in between injections.

Botox for muscle spasms in MS: What to know

The effects of the botulinum toxin may spread from the area of injection and produce symptoms that may last weeks after injection. Swallowing and breathing difficulties can be life threatening. Children treated for spasticity may have a greater risk, but risk can also occur in adults.

The most common adverse reactions reported by patients with spasticity are nausea, fatigue, bronchitis, muscle weakness, and pain in the arms.

Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.

 

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Low-dose Botox Treatment Improves Urinary Symptoms in MS Patients, Study Finds

Results from a Phase 3 clinical trial show that urinary symptoms can be reduced significantly after treatment with low-dose Botox (100 units) in patients with multiple sclerosis (MS).

That finding was reported in the study “Low-dose onabotulinumtoxinA improves urinary symptoms in noncatheterizing patients with MS,” published in the journal Neurology. 

Most patients with MS develop neurogenic detrusor overactivity (NDO). The detrusor muscles are part of the bladder and are involved in bladder contractions. Because of nerve damage caused by MS, the communication between the spinal cord and the bladder is disrupted and the detrusor muscles become overactive. This results in sporadic and frequent urine leakage. Not surprisingly, NDO can severely affect MS patients’ quality of life.

Treatments for NDO are usually invasive, and may include surgery and the use of implantable devices.

Botox (onabotulinumtoxinA), a minimally invasive option, is approved for the treatment of NDO associated with MS. Studies have shown that injections of Botox (200 units) can reduce urinary incontinence and improve the patient’s quality of life. However, high doses of Botox are associated with a potential risk of complications, including urinary retention requiring clean intermittent catheterization (the insertion of a catheter into the bladder to help the person urinate).

A previous Phase 3 trial (NCT00910845) testing Botox in patients with idiopathic overactive bladder with urinary incontinence (non-MS patients) showed that Botox at 100 units (half the dose) could reduce urinary incontinence.

In 2015, researchers completed a Phase 3 trial (NCT01600716) to assess the safety and effectiveness of Botox (marketed by Allergan) at a dose of 100 units  in noncatheterizing patients with MS and urinary incontinence due to NDO, to determine if the lower dose could reduce urinary symptoms in these patients.

The trial included 144 noncatheterized patients with clinically stable MS, and a history of NDO for more than three months.  These patients were recruited from 58 sites across North America and Europe between July 2012 and March 2015.

In total, 66 patients received 1 mL injections of Botox (100 units) distributed evenly into the detrusor muscle, while 78 patients received injections of a placebo. Patients were followed for 52 weeks (one year), with check-ups at 2, 6, 12, 24, and 52 weeks.

Significant decreases in urinary incontinence episodes in patients treated with Botox were seen as early as two weeks after the injection. This trend continued through week 12. At week six, more patients treated with Botox reported a more than 50% reduction or total reduction in urinary incontinence episodes per day, compared to patients treated with placebo.

Botox treatment also increased the maximum cystometric capacity — referring to the volume at which the patient feels he/she can no longer delay urination — compared to placebo, and significantly decreased the pressure in detrusor muscles.

Results showed that while symptoms of urinary incontinence decreased, bladder function improved.

Regarding incontinence-related quality of life, greater improvements were seen in patients treated with Botox.

Importantly, treatment with Botox was long-lasting. Duration of Botox’s effect (i.e., median time until  request for another treatment) was 51.7 weeks, compared to only 12.6 weeks in patients treated with placebo. Only 45.5% of patients treated with Botox requested a second dose, while 85.9% of patients treated with placebo requested a second treatment.

Botox was generally well-tolerated, and adverse effects for this treatment were low. The most common adverse event reported was urinary tract infection (25.8%).

Overall, the team concluded “in noncatheterizing patients with MS and NDO, treatment with onabotulinumtoxinA 100 [units] results in significant and clinically relevant improvements in UI [urinary incontinence] and other urinary symptoms, urodynamics, and QOL [quality of life]…than previously reported with onabotulinumtoxinA 200 U,” they wrote.

The team also emphasized that “more than half the patients (53%) treated with onabotulinumtoxinA became incontinence free (i.e., “dry”) at week 6 after treatment.”

Of note, the study was funded by Allergan, and the results are specific to the Botox formulation used. Other botulinum toxin products may not have the same results.

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