FDA Approval of New Therapy for Urinary Control
Provides New Hope for Patients
New York, NY (May 1999) -- A therapy that offers new
hope to the millions of people who suffer from severe urinary control problems
and do not respond to or are dissatisfied with drug or behavioral treatments
is now available at New York Weill Cornell Center of New York Presbyterian
Hospital.
InterStim Therapy for Urinary Control, recently approved for three indications
by the U.S. Food & Drug Administration (FDA), has been found
in clinical trials to be a promising treatment option for those who suffer
from urinary urge incontinence, urinary retention or significant symptoms
of urgency-frequency, all of which are conditions that can destroy the
ability to hold a job and live a normal life. Of the estimated 13
million Americans who suffer urinary control problems, approximately 85
percent are women between the ages of 30 and 59--women who are in the most
active, productive years of their lives.
"This new therapy can help people with severe types of incontinence
regain their ability to work and perform normal activities without fear
of embarrassment," said George Young, M.D., of the Department of Urology
at New York Weill Cornell. "It represents a new type of treatment
for incontinence, one that many patients should consider before resorting
to bladder augmentation, bladder removal or other irreversible surgical
options."
People with urinary urge-incontinence or significant symptoms of urgency-frequency
may feel a strong urge to urinate as many as 40 times a day and often are
embarrased by wetting episodes. Although a variety of therapies are
available to them, as many as 30 percent may not respond well to
incontinence medications. People with urinary retention have difficulty
going to the bathroom. They have few therapy options and must use
a catheter to empty their bladders.
InterStim Therapy uses neurostimulation to send mild electrical pulses
to the sacral nerves that control bladder function. A stopwatch-sized
neurostimulator, surgically placed under the skin of the abdomen, generates
mild pulses that are carried via a thin implanted lead, or wire, to the
sacral nerves in the lower back.
A simple diagnostic trial--or test stimulation--initiated in a physician's
office can help assess whether this therapy will prove effective for individual
patients. Physicians can test its potential effectiveness before
surgical placement of the neurostimulator by adjusting the strength of
stimulation for each patient. If the therapy fails to provide satisfaction,
it can be turned off or removed completely.
