Earlier this year, the U.S. Food and Drug Administration (FDA) approved the use of Botox to treat both men and women with overactive bladder or who cannot use or do not respond to anticholinergics. It was already approved for the treatment of urinary incontinence due to overactive bladder that was related to nerve damage from conditions such as multiple sclerosis and spinal injury.
Botox helps urinary incontinence by relaxing the bladder, which allows it to store more urine. According to the National Institutes of Health, several studies have demonstrated the effectiveness of Botox as a treatment for overactive bladder. Improvements in incontinence episodes, quality of life, maximum detrusor pressure, and bladder capacity were reported for Botox versus a placebo.
Urologist Nicole D. Massie, MD, of Urology Centers of Alabama, says the Botox treatment has been available for a while for other uses, such as rectal spasms and migraines. The recent FDA approval has given her an additional tool to use on patients with bladder control issues. “The Botox treatment is specifically for patients with overactive bladder urgency and urge incontinence problems,” she says. “This is for people with no control where medications have failed or they cannot tolerate the medicines.”
The outpatient procedure is done in the physician’s office through a cystoscope. The surgeon injects a small dose of Botox into the bladder wall under the lining of the mucosa layer. “We use an extremely small dose and divide it for use in different areas in the bladder,” Massie says. “It is the same process used in other areas of the body to relax or paralyze muscles, but for an overactive bladder we use a small amount so the patients can still void their bladders.”
In a study of nearly 250 women who had urge incontinence, published in the October 4, 2012, issue of the New England Journal of Medicine, a one-time Botox injection in the bladder worked as well as daily pills at reducing episodes of urinary incontinence at six months. However, the patients given Botox were significantly more likely to report complete resolution of urinary incontinence. A full 70 percent of women in both groups reported an average of three leaks a day at the six-month mark compared to an average of five a day at the start of the study.
The initial treatment usually lasts about four months, Massie says, while subsequent treatments can last as long as 10 months. “Each successive treatment lasts longer, and it is interesting that while symptoms may come back, they aren’t as bothersome. We can get women from soaking diapers into thin panty liners. That is so much more comfortable and less costly,” she says.
Massie says they still follow their first-line treatment with patients before using the Botox injections. “We do diet and behavior modification and double voiding. We also recommend avoidance of sodas, coffee and tea,” she says.
Risks associated with Botox injections include, but are not limited to, urinary tract infections, blood in the urine, and pain with urination. Six to 17 percent of patients will experience urinary retention. However, Massie notes that she has not observed a high retention rate. Those who develop urinary retention may require self-catheterization to empty the bladder. “To help avoid infection, we test patients ahead of time to make sure we are dealing with sterile urine,” Massie says. “Urinary retention is the most bothersome side effect, but we can test patients and determine ahead of time who might have this problem. We counsel these patients and teach them to catheterize themselves. The good things is that these side effects are reversible.”
Massie sees more uses for Botox therapy in the future for men and women as further studies are done. “I think because of what Botox can do, any condition that causes hyper-spasticity of the nerves can be improved with this type of treatment,” she says.
The availability of Botox injections for her patients has been a welcome addition to the treatment regimen in Massie’s practice. “These injections give bladder patients another avenue of treatment,” she says. “I now have the ability to offer them different, effective options.”