People with some neurological conditions can have uninhibited urinary bladder contractions, making it harder for the bladder to store urine. Currently, patients with this conditions may be given medications to relax the bladder, while some may have to use a urinary catheter.
When Botox is injected into the bladder, it relaxes, improving its storage capacity and reducing the risk of urinary incontinence.
George Benson, deputy director, Division of Reproductive and Urologic Products, FDA, said:
"Urinary incontinence associated with neurologic conditions can be difficult to manage. Botox offers another treatment option for these patients."
The Botox is injected into the bladder using a cytoscope - a lighted instrument that goes through the urethra (tube that carries urine from the bladder to outside the body). Sometimes general anesthesia is required. The treatment is effective for about nine months.
Before approving Botox for this treatment, the FDA looked at data on two clinical trials involving 691 participants - they all had urinary incontinence resulting from multiple sclerosis or spinal cord injury. In both studies, patients receiving Botox had significantly fewer weekly episodes of incontinence compared to those who were given placebo.
Botox is already FDA-approved for treating facial frown lines, chronic migraine, severe underarm sweating, some types of muscle stiffness and contraction, improper alignment of the eyes, and abnormal twitch of the eyelid.
Possible side effects may include urinary retention and urinary tract infection. Patients who develop urinary retention may have to use a catheter to empty their bladder.
In the USA, Botox is marketed by Allergen Inc.