Company Press Release
Bladder Pacemaker Restores Urinary Control

http://biz.yahoo.com/bw/980813/stanford_p_1.html

STANFORD, Calif.--(BW HealthWire)--Aug. 13, 1998--Just as a cardiac
pacemaker helps maintain a steady heartbeat, a new bladder pacemaker
helps men and women with debilitating bladder problems regain control of
this vital function, according to UCSF Stanford Health Care physicians,
who pioneered the technology.

The implantable bladder pacemaker delivers a painless electrical
stimulus to the nerve fibers that regulate the muscle of the bladder.
This enables patients to control urine storage and release, said Dr.
Emil Tanagho, a UCSF professor of urology whose early work with
paraplegics and quadriplegics led to the development of the device.

He and Dr. Rodney Anderson, a Stanford professor of urology, are among
the three physicians in California -- and the only two in Northern
California -- who are currently implanting the device. The Food and Drug
Administration approved the device in September 1997.

Tanagho said the new pacemaker may benefit patients suffering from urge
incontinence, the inability to control the strong, sudden urge to
urinate. It could also help people with severe bladder problems
associated with multiple sclerosis, PARKINSON'S disease, interstitial
cystitis or pelvic pain produced by overactive pelvic muscles, he said.

People who lack bladder control can be virtually incapacitated by their
condition, making multiple daily trips to the restroom and suffering the
embarrassment and discomfort of frequent bladder leakage, he said.

The bladder pacemaker ``is a major breakthrough in the management of
many patients with severe voiding problems that can interfere with their
well-being,'' Tanagho said. ``It can restore their freedom and give them
back normal function.

``For these patients it's a major change in lifestyle as well as
productivity,'' he added. ``It's a quality-of-life issue, and the
difference is day and night.''

Implanted Under Skin

The pacemaker, about two inches in diameter and one-fourth inch thick,
is encased in a stainless steel frame and is surgically implanted under
the skin in the lower abdomen. It carries a lead wire, containing
four platinum electrodes, that is threaded to a site within the sacral
canal, near the sacral nerves at the base of the spine. These are the
nerves that regulate bladder function.

Once installed, the device is externally programmed by the physician to
send electrical impulses to the nerves. This signals the bladder and
pelvic muscles to contract or relax as urine is stored or eliminated.
Patients can also regulate the device, within certain set limits, by
turning it up or down.

In clinical trials in the United States, Canada and Europe, the device
reduced the number of leaking episodes among 74 percent of the 458
patients within six months after implantation. Almost half of the
patients remained completely dry. The most common problems associated
with the device were discomfort at the pacemaker site caused by the
presence of the device, the movement of the lead wire, infection and
skin irritation, the studies found. But all of these were mild and
infrequent, the studies found.

When the stimulation is on, patients usually report feeling a kind of
tugging sensation and may experience a vibration or an electric
tingling, but over time they may forget the device is in place, Anderson
said.

Few Treatment Options

The device is a much-needed addition to the medical arsenal, he said,
because in the past physicians have had few options to offer patients
with severe bladder control problems. Some medications can help
regulate bladder function, but they don't work for all patients and can
have unpleasant side-effects, he noted. Some patients may undergo a
surgical procedure known as bladder augmentation, but it is a major
operation that has mixed results, he said.

``We just have very weak tools to combat this kind of problem, so this
(device) is a welcome addition,'' Anderson said.

Patients go through a preliminary, three-to-seven-day period of testing
before the bladder pacemaker can be installed. This involves use of a
test stimulator, resembling a pager, that the patient can wear on a
belt. The stimulator is attached to a pacer electrode that is placed
through the skin of the patient's lower back, where it generates an
electrical pulse to the sacral nerves.

About 50 percent of the time, the test stimulator is found to help
relieve patients' symptoms and restore bladder control, Anderson said.
These individuals then can be fitted with the implantable device. For
patients, installation is a relatively simple surgical procedure that
takes 1 1/2 to two hours, he said.

Although few physicians currently have experience in installing the new
device, Tanagho said he expects the the pacemaker to gain wider
availability over time as more urologists receive the specialized
training required for its implantation and use.

A Patient's Perspective

Dianalynn Pfennig, a patient with multiple sclerosis, said her bladder
problems became so severe that she would always bring a change of
clothes with her when she left the house. In 1996, her doctor
recommended that she be fitted with a catheter, a tube attached to the
bladder which must be drained several times a day. She said she knew a
catheter would be severely limiting and could make her susceptible to
bladder infections.

``I'm living here in the center of technology,'' said Pfennig, a
resident of San Jose, Calif. ``I told my doctor, 'There's got to be a
better way.'''

She contacted Anderson, who was studying the still-experimental device
at the time. Anderson fitted her with a bladder pacemaker at Stanford in
July 1997. Pfennig said she has been virtually dry ever since,
although she still brings a change of clothes wherever she goes, out of
sheer habit.

``It's been the best thing that's ever come down the pike for me,'' she
said.

Original Concept

The original concept for the device grew out of Tanagho's research in
the 1970s on methods for managing the bladder in patients with spinal
cord injuries. Duke University researchers had proposed a
method of implanting an electrode in the spinal cord for this purpose,
but Tanagho said he found that this approach could damage the cells in
the spinal cord that control urination.

With support from the National Institutes of Health, he then began
exploring the idea of implanting electrodes into the nerve bundles in
the sacral root, conducting clinical trials in the 1980s on paraplegic
and quadriplegic patients. In the process, he said, he found that
neurostimulation also could be helpful to much less severely injured
patients who nonetheless had difficulties with bladder control.

``We found we could rehabilitate them and restore normal bladder
function,'' he said.

In the late 1980s, Tanagho directed clinical trials on the
first-generation bladder pacemaker, recruiting Anderson to participate.
UCSF now holds the patent on the technology, which is licensed to
Medtronic Inc. [NYSE:MDT - news], of Minneapolis. Medtronic manufactures
the device under the trade name Interstim.

Copyright © 1998 Business Wire.
--
Judith Richards, London, Ontario, Canada
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