Stimulation Procedure Is Promising Option for Treating Bladder Control
incontinence patients who have not responded favorably to traditional
therapy options have an option for an alternative treatment that is
proving to be effective in patients treated at Emory University. An
implanted stopwatch-sized device acts as a 'pacemaker' by determining
the rate of firing of the muscles in the pelvic floor and can change
the way the bladder and bowel behaves.
The InterStim® Therapy,
developed by Medtronic, Inc., is a sacral nerve stimulation device that
sends mild electrical pulses to the sacral nerves in the lower back
that control the bladder, sphincter and pelvic floor muscles.. The neurostimulator
is placed under the skin of the abdomen and generates mild impulses
via a thin wire.
"With the InterStim®
implant, our incontinence patients are experiencing a significant reduction
in leaking episodes and in some cases, complete relief from leaking
episodes," says Dr. Niall Galloway, FRCS, associate professor of urology
and medical director of the Emory Continence Center.
According to Dr. Galloway,
individuals carry a lot of guilt, shame and embarrassment with problems
below the belt and are reluctant to seek help. "In the United States,
patients wait an average of 7-8 years with moderate or severe incontinence
before they seek help. The prevalence is far higher than people understand.
There are more people with moderate or severe incontinence in the Unites
States than all people with cancer and all with diabetes combined."
Interested urge incontinence patients are pre-screened to determine
their eligibility for the procedure. Most have undergone previous medical
treatment such as medication, pelvic floor exercises or other surgeries
that proved to be ineffective in alleviating their condition.
The InterStim® procedure
is a two-stage process. First, the physician internally places electrodes
in the patient's lower back, using X-rays for precise placement. The
electrodes are then tested to confirm perfect position before they are
attached to an external device. The patient wears the test stimulator
for approximately one week.
"This allows us to predict
whether or not the final implant will work for patient," says Dr. Galloway,
who has performed almost twenty InterStim¨ implants. "Consequently,
every time you do an operation it is a success because you've selected
out only those patients who will do well."
If the patient's symptoms
have resolved in the presence of electrical stimulus, the electrodes
are attached to an implanted neurostiumulator. A hand-held electromagnetic
device allows the patient or doctor to non-invasively control and adjust
the strength of the stimulation, described by most people as a slight
pulling sensation in the pelvic area; in the scrotum area for men and
in the vagina for women.
"Without this sort of simple
technology, we would have to do major reconstruction surgical operations
for patients with severe incontinence that might create new problems
for them," Dr. Galloway says.
InterStim® Therapy is
completely reversible and can be discontinued at any time with no permanent
damage to the nerves.
The U.S. Food and Drug Administration
(FDA) approved InterStim® for use with urge incontinence patients
in September 1997 and later for urgency-frequency and urinary retention
patients in April 1999. Currently, almost 6,000 implants have been performed
More than 13 million people
in the United States experience urinary incontinence, including urinary
urge incontinence, urinary retention, and symptoms of urgency-frequency.
Individuals with urge incontinence or urgency-frequency experience involuntary
bladder contractions that cause urine leakage or the sudden urge to
urinate. Individuals with urinary retention have problems emptying their