THURSDAY, Oct. 4 (HealthDay News) -- Botulinum toxin, the
anti-wrinkle treatment known as Botox, can also help women with
urge incontinence reduce their leaking episodes, according to a new
Injecting Botox into the bladder worked as well as daily
solifenacin pills, a commonly prescribed treatment for
incontinence, the researchers found.
The Botox treatment is already approved by the U.S. Food and
Drug Administration for urge incontinence due to known neurological
injuries such as spinal cord trauma, said lead study Dr. Anthony
Visco, chief of urogynecology and reconstructive pelvic surgery at
Duke University Medical Center in Durham, N.C.
It is not yet approved for incontinence without a recognized
cause, known as idiopathic incontinence.
Visco and his colleagues conducted what they believe is the
first head-to-head comparison of medication and the botulinum
They will present their results at this week's annual meeting of
the American Urogynecologic Society in Chicago. The findings also
will be published online Oct. 4 in the
New England Journal of Medicine.
The researchers assigned nearly 250 women, all with urge
incontinence, to either take daily medication and get saline
injections or to get daily placebo pills and Botox injections. The
women on average were in their mid- to late-50s.
With urge incontinence, the bladder is overactive and
unpredictable. Up to one in five older women in the United States
is affected, Visco said.
The pill used to treat the condition, solifenacin (brand name
Vesicare), works by relaxing the bladder muscle. If the initial
5-milligram dose didn't help, the researchers upped the dosage to
10 mg. If that didn't work, the women were switched to another
commonly used drug, trospium XR (Sanctura).
The Botox works, Visco said, by helping relax the muscles so
they are not overactive. Botox injections are done via cystoscopy,
in which a lighted instrument is introduced into the bladder. The
Botox is injected at 15 or 20 sites and then spread evenly over the
surface of the bladder, Visco said.
For six months, the women in each group kept a three-day diary
once a month, noting how many episodes of incontinence they had. At
the beginning, the women had an average of five episodes per
After six months, the average reduction in incontinence episodes
was nearly the same: 3.4 episodes in the pill group and 3.3 in the
"They both work very well," Visco said.
However, he said, "the groups that received Botox had a two-fold
higher likelihood of achieving complete resolution of their
Twenty-seven percent of those on Botox said they had no daily
episodes of leaking after six months compared with 13 percent of
those taking the pills.
Both groups reported side effects. Dry mouth occurred in 46
percent of those taking the pills and 31 percent of those using
Botox. Those on Botox were much more likely to get a urinary tract
infection, with 33 percent of them reporting one.
Those on Botox sometimes had urinary retention and had to use a
At six months, treatments were stopped. A month later, 50
percent of the women on pills still had relief of symptoms, versus
62 percent of those who got Botox. A year later, 25 percent of
those on pills and 38 percent of those on Botox still had
Visco estimated that the Botox would need to be repeated every
nine months or so.
Another expert who reviewed the study commented on its
Botox "might be a viable option for people who have failed
regular therapy," said Dr. Peter Galier, an internal medicine
specialist at UCLA Medical Center in Santa Monica, Calif., and
associate professor of medicine at UCLA's David Geffen School of
Medicine in Los Angeles.
It is crucial, he said, to be sure the diagnosis is urge
incontinence and that symptoms are not due to other problems. He
would prescribe other medication first, he said, and turn to the
Botox treatment if the medication did not work.
The risk of infection with the Botox injections should be
considered, he said.
The price of standard medication varies, as does insurance
coverage. A month's supply of low-dose Vesicare, for instance, can
cost about $230.
Allergan, which makes Botox, has now asked the FDA for approval
for adults with idiopathic urge incontinence for whom standard
medicines don't work, said company spokeswoman Heather Katt.
Allergan declined to estimate costs of the injections for urge
incontinence, but Katt said many plans cover the treatment for
neurogenic urge incontinence and also would be expected to do so
for the new indication, if it is approved.
The U.S. National Institutes of Health funded the study. Visco
has no pharmaceutical company ties to report. Some co-authors
report serving as consultants for Astellas Pharma US and
GlaxoSmithKline, which make Vesicare.
To learn more about incontinence, visit the
U.S. National Institutes of Health.
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