May 20, 2004


THE INFORMED PATIENT
By LAURA LANDRO

DOW JONES REPRINTS

This copy is for your personal, non-commercial use only. To order
presentation-ready copies for distribution to your colleagues, clients or
customers, use the Order Reprints tool at the bottom of any article or
visit:
http://www.djreprints.com.

.. See a sample reprint in PDF format.
.. Order a reprint of this article now.
What do people think of this?

=========================================


New Options for Treatment
Of Prostate Problems
May 20, 2004; Page D1

It is an inevitable aspect of getting older for most men: that little
walnut-sized gland known as the prostate is bound to start causing trouble.

With an aging population of male baby boomers, the race is on among
pharmaceutical companies, surgical-equipment makers and researchers to
deliver new treatments for benign prostatic hyperplasia, the medical term
for a nonmalignant enlargement of the prostate gland.

Though not a deadly scourge like prostate cancer, BPH is actually far more
common, appearing in some men as young as 40, and striking 60% of men over
60 years old. In all, more than eight million men in the U.S. are treated
for BPH, at a cost of around $3.5 billion a year.

The prostate, which makes the fluid that carries sperm during ejaculation,
enlarges in almost all men as they get older, pressing on the urethra which
empties urine from the bladder. The most common symptom is frequent and/or
difficult urination. Unfortunately, men often ignore the problem and avoid
unpleasant diagnostic tests such as the digital rectal exam. Left untreated,
BPH can lead to serious complications such as urinary-tract infections,
incontinence, impotence, bladder and kidney damage and bladder stones.


Some alternative treatments for benign prostatic hyperplasia

.. Transurethral needle ablation (TUNA): Heats the prostate via a small
needle attached to a rigid telescope.

.. Transurethral holmium laser resection: In very enlarged prostates, uses
laser light and fibers to reduce tissue.

.. Transurethral microwave heat treatment: Uses a small microwave antenna
attached to the end of a flexible tube.


See the benefits and risks0 of the most-common BPH treatments.

The traditional treatment involves either surgery under general anesthesia
to remove prostate tissue or -- in less-severe cases -- drugs, which
patients often must take for years and can cause impotence themselves.

But newfangled, minimally invasive treatments are now available or are being
studied that promise to lessen the risks and side effects, including several
procedures that use heat from microwaves and other sources to shrink or
vaporize tissue. A treatment from Minneapolis-based Medtronic Inc., known as
transurethral needle ablation, or TUNA, heats the prostate via a small
needle in order to shrink or vaporize tissue. The procedure, which is
approved by the Food and Drug Administration and covered by Medicare,
destroys only obstructive tissue and leaves the urethra and the rest of the
prostate intact.

Other approved therapies that Medicare is now starting to cover include the
use of laser heat and fibers to vaporize prostate tissue with only minor
post-surgical complications, such as a holmium laser marketed by Lumenis and
Boston Scientific. One experimental technique unveiled at the annual meeting
of the American Urological Association last week in San Francisco by
researchers at the University of Pittsburgh even uses injections of
botulinum toxin -- the Botox used in cosmetic procedures -- to temporarily
reduce prostate tissue. Some other emerging therapies that experts say are
options to consider but too new to recommend over more proven treatments
include the injection of ethanol into the prostate, the use of
high-intensity ultrasound and light waves to shrink it, and various herbal
remedies.

Like traditional treatments, the newer ones offer only relief from the
symptoms of BPH and not a cure. But proponents say the newer methods are far
less costly and risky than surgery. And in some cases they may offer quicker
relief than the two types of common drugs: alpha-blockers such as
Sanofi-Synthelabo Inc.'s Uroxatral and Boehringer Ingelheim Pharmaceuticals'
Flomax, which relax the muscles of the prostate to allow regular flow of
urine; and inhibitors of the enzyme 5 alpha-reductase, such as Merck & Co.'s
Proscar and Propecia, which shrink the prostate by interfering with hormones
that cause it to enlarge.

Many of the new methods lack strong clinical evidence and long-term results,
however. The array of relatively new techniques can also be daunting to
patients as well as to doctors untrained in new procedures.


RELATED ARTICLE

.. Prostate Treatment Approved1


The good news is that "there are a growing array of new treatment options"
instead of drugs and conventional surgery, says John McConnell, chairman of
urology at the University of Texas Southwestern Medical Center in Dallas.
But "not all of these are well-accepted therapies yet."

For example, the Botox study conducted by the University of Pittsburgh and
Chang Gung Memorial Hospital in Taiwan evaluated injections in eight dogs
and 16 human subjects. Michael Chancellor, the professor of urology and
gynecology at Pittsburgh involved in the study, says that the subjects'
symptoms improved within a week and the benefits lasted as long as eight
months.

While he acknowledges it's too soon for sweeping conclusions, he says it's
something to consider for younger men who want to avoid side effects of
drugs and surgery. Botox, which was created by Allergan Inc., is approved by
the FDA as a cosmetic treatment, so no additional regulatory approval is
needed for this off-label use. But it is only beginning to be studied by
researchers in limited tests for prostate treatment.

Guidelines from the American Urological Association suggest patients seeking
alternatives stick with drugs or minimally invasive remedies that use heat,
such as TUNA and microwaves, for which there is a growing body of scientific
evidence. Patients can go to the group's Web site (http://www.urologyhealth.org2)
for guidance in evaluating treatments, as well as help finding a urologist.
And there are detailed guidelines for diagnosing and treating BPH on the
group's Web site for doctors, http://www.auanet.org3.

Michael Manyak, chairman of the Department of Urology at George Washington
University, says patients should quiz doctors about newer treatments and
their experience with the procedures -- and ask if they have any "vested
interest" in a particular technology or company.

Doctors often recommend watchful waiting for men with milder or earlier
cases of BPH. But once the symptoms become more severe -- for instance if a
man is unable to completely empty the bladder, or is kept awake by the need
to urinate -- they will recommend treatment.

Increasingly, doctors are prescribing a "****tail" of two types of commonly
used BPH drugs, which studies show can be more effective than either alone.
But while combining the alpha blockers and enzyme inhibitors may be more
effective, a study by Allen Seftel, a urology professor at Case-Western
Reserve University School of Medicine in Cleveland, presented at last week's
conference, said ***ual dysfunction from both BPH itself and the treatments
is nearly twice as high as treating physicians believe.

Doctors are treating ***ual side effects with erectile-dysfunction drugs
such as Viagra or Levitra. But there are some restrictions when taking these
medications along with BPH drugs. For example, a patient using Viagra must
wait four hours before using an alpha blocker, and needs to time ***ual
activity accordingly, Dr. Seftel adds.

If patients cannot tolerate medications or their side effects, or don't
comply with the regimens, minimally invasive treatments with more immediate
results can be done as outpatient procedures under light or no sedation.
TUNA and microwave treatments, for instance, can be done as outpatient
procedures, though doctors say the needle procedure may be more
uncomfortable than the microwaves.

In more severe cases of BPH, surgeons may still recommend the traditional
removal of the inner portion of the prostate under general anesthesia in a
hospital -- known as transurethral resection -- though there can be serious
complications, including impotence and incontinence, and 10% of patients may
need another procedure within five years.

Daniel W. Nixon, an oncologist and co-author of a helpful new book, "The
Prostate Health Program," says men concerned about developing BPH can take
some steps to help prevent it by improving their diet including eating less
red meat, consuming less alcohol and caffeine, as well as getting plenty of
exercise. Some physicians are also starting to recommend supplements that
contain ingredients such as soy, selenium, vitamin D, vitamin E and
lycopene.


----------------------------------------------------------------------------
----

Weighing the Choices
Benefits and risks of the most-common treatments for benign prostatic
hyperplasia.

Treatment
Appropriate For
Comment

Watchful waiting
Early or milder symptoms that come and go
Involves one checkup a year for follow-up. Small risk of worsening
symptoms.

Alpha blockers
Moderate symptoms
Side effects include stomach distress and headache.

5 alpha reductase inhibitors
Milder symptoms
Relatively small risk of ***ual dysfuction.

Combination drug therapy
Moderate symptoms
Combined side effects of both drugs.

Transurethral microwave heat treatment
Moderate to more severe symptoms
Procedure involves local anesthesia. Side effects include small risk of
frequent urination.

Transurethral needle ablation
Moderate symptoms
Side effects similar to transurethral microwave heat.

Laser and other minimally invasive surgery
Severe symptoms
Involves spinal or general anesthesia. Side effects include urinary
problems and ***ual dysfunction.

Open surgery
Severe symptoms
Involves general anesthesia. 69% risk of incontinence.


Source: American Urological Association

Return to story3

.. Send e-mail to Informedpatient@wsj.com4.

URL for this article:
http://online.wsj.com/article/0,,SB108499961305616039,00.html


Hyperlinks in this Article:
(1) http://online.wsj.com/article/0,,SB108501281822016484,00.html
(2) http://www.urologyhealth.org
(3) http://www.auanet.org
(4) mailto:Informedpatient@wsj.com


Copyright 2004 Dow Jones & Company, Inc. All Rights Reserved

This copy is for your personal, non-commercial use only. Distribution and
use of this material are governed by our Subscriber Agreement and by
copyright law. For non-personal use or to order multiple copies, please
contact Dow Jones Reprints at 1-800-843-0008 or visit http://www.djreprints.com.