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 Researchers tested onabotulinumtoxinA (Botox) against InterStim in
patients with overactive bladder who couldn’t tolerate or didn’t
respond to other drugs or treatments such as pelvic floor muscle
training or fluid restriction.
Six months after treatment, women randomly assigned to receive Botox
injections in the bladder muscle had an average of 3.9 fewer
episodes of incontinence a day, compared with 3.3 fewer accidents
with InterStim.
That small difference is statistically meaningful, but it may not be
clinically important and is based on twice the Botox dose
recommended for overactive bladder, researchers conclude in JAMA.
“Both treatments are very good options,” said lead study author Dr.
Cindy Amundsen of Duke University in Durham, North Carolina.
Millions of older women in the U.S. alone suffer from urinary
incontinence, a condition that is linked to obesity and having had
multiple pregnancies.
Botox, commonly used to smooth wrinkles, can also relax muscle
spasms that cause incontinence. Women selected for this treatment in
the study received injections of 200 units of Botox; the usual
recommended maximum dose in the U.S. for overactive bladder is 100
units.
InterStim is placed under the skin just above the tailbone and works
by sending mild electric impulses to the sacral nerves that control
movement and sensation in parts of the pelvis in order to prevent
bladder contractions. Patients use a remote control to adjust the
intensity and turn the device on and off. Over time, the stimulation
may improve communication between the brain and the bladder,
reducing incontinence.
At the start of the study, women were around 63 years old on average
and typically overweight or obese.
They were having an average of six episodes of incontinence a day.
Over six months, women in both treatment groups reported similar
improvements in quality of life, though they reported a bigger
reduction in bothersome symptoms with Botox.
Both options had some side effects.
Urinary tract infections were common, affecting 35 percent of the
women in the Botox group and 11 percent of the patients with
InterStim implants.
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Among the women with these infections, 39 percent in the Botox group
and 30 percent in the InterStim group had at least two during the
study period.
In addition, six women with InterStim, or 3 percent, had to have
procedures to revise or remove the devices.
With Botox, 8 percent of women needed to remove excess urine with
catheters one month after treatment, as did 4 percent at three
months and 2 percent at six months. A previous study done to
determine the safest dose of Botox for overactive bladder found that
21 percent of patients needed intermittent catheterization, the
authors note.
One limitation of the study is that women received a single Botox
injection, making it impossible to determine how a series of shots
or other doses might be more effective than InterStim, the authors
caution. They also didn’t have a placebo group.
The unusually high dose of Botox in the study may also be considered
a design flaw, said Dr. Victor Nitti, director of female pelvic
medicine and reconstructive surgery at New York University Langone
Medical Center.
“Nevertheless, Botox did very well and actually had a low incidence
of side effects and a low incidence of patients needing to
catheterize – even lower than expected,” Nitti, who wasn’t involved
in the study, said by email. “The bottom line is both of these
treatments are reasonable for women with refractory overactive
bladder.”
SOURCE: http://bit.ly/2d0FfSv JAMA, online October 4, 2016.
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