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Botox injection approved by FDA for bladder leakage, incontinence

Kathleen Blanchard's picture

The FDA has approved Botox to treat urine leakage and incontinence. The bacterium - onabotulinumtoxinA - is commonly used to treat wrinkles and migraine headaches because it relaxes muscles.

In a press announcement, the FDA approved the drug to treat overactive bladder and urinary incontinence that stems from neurological causes such as multiple sclerosis and spinal cord injury.

The decision to approve Botox to treat bladder incontinence comes after 691 patients were studied in two clinical trials.

Botox improved urinary incontinence in spinal cord injury, MS

Compared to placebo, the drug injection “significantly” reduced weekly episodes of urinary incontinence in patients with spinal cord injury and multiple sclerosis.

Botox blocks nerves and weakens muscles, making it useful for treating muscle disorders, which include cervical dystonia – a condition that causes severe pain from muscle spasms in the neck and shoulder.

The drug comes from the bacterium Clostridium botulinum, which causes food poisoning. In small dose injections the bacteria is not toxic.

George Benson, deputy director, division of Reproductive and Urologic Products said, “Botox is “another treatment option” for patients who have difficulty controlling urine flow.”

The drug increases the capacity of the bladder to hold more urine and relaxes the muscle to stop unexpected urine leakage.

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The effect of Botox, marketed by the drug company Allergan, bladder can last up to nine months. General anesthesia might be required.

Current treatment for overactive bladder and incontinence include self-catheterization and drugs that also block nerve signals, known as anticholinergics, which must be taken daily.

The drugs have side effects and are contraindicated for people with glaucoma and chronic constipation.

According to the National Institutes of Health, the incidence of overactive bladder (OAB) isn’t known, but may be as high as 43 percent. Sufferers of the condition often fail to discuss their condition or seek treatment.

Symptoms of OAB include urinary frequency, sudden urge to urinate and inability to control urine flow that can impact quality of life and interfere with activities of daily living.

The condition is more prevalent in woman than men. Urinary incontinence in the presence of neurological diseases can lead to frequent infections and increased rates of hospitalization.

FDA approval of Botox for treating urinary incontinence and overactive bladder, which may be more prevalent that known, especially for people between 35 and 55 years of age, offers another option to daily medication use, bladder training or catheterization to keep the bladder empty.

Resource: PubMed
"The Prevalence of Overactive Bladder"

Image credit: Wikimedia commons