Department of
Health and Human Services
National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases
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August 19, 2004
Contact: Mary M. Harris 301-496-3583
http://www.niddk.nih.gov/
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NIH Launches New Study to Compare Prostate Surgery and Drugs
BETHESDA, MARYLAND - The Minimally Invasive Surgical
Therapies (MIST) Consortium for Benign Prostatic
Hyperplasia (BPH) has launched a new study to compare long-
term benefits and risks of transurethral needle ablation
(TUNA) and transurethral microwave thermotherapy (TUMT) to
a regimen of the alpha-1 inhibitor alfuzosin and the 5-
alpha reductase inhibitor finasteride. The National
Institute of Diabetes and Digestive and Kidney Diseases at
NIH, part of the Department of Health and Human Services,
is investing more than $15 million in the study.
TUNA and TUMT use heat to destroy part of the enlarged
prostate to improve urine flow and symptoms. Early studies
suggest that these procedures reduce the occurrence of
erection or bladder control side effects, which occur more
often with the traditional surgery for BPH, known as
transurethral resection of the prostate (TURP). TUNA and
TUMT are said to be minimally invasive in part because they
typically are done with local anesthesia and men go home
the same day, whereas TURP requires general anesthesia and
an overnight hospital stay. As for drug therapy, a recently
published large randomized study showed that a regimen of
finasteride (Proscar) and the alpha-1 inhibitor doxazosin
(Cardura) prevents progression of BPH in a significant
percentage of symptomatic men and it helps men at high risk
avoid surgery.
"It's easy to see why drug therapy, TUNA and TUMT have been
embraced by many urologists and patients," said Leroy M.
Nyberg Jr., Ph.D., M.D., director of NIDDK's urology
trials. "Yet, we don't know which treatment is more
effective in the long run and, for the most part, who would
be better served by the drug combination versus one of the
minimally invasive therapies."
By July 2006, researchers plan to have recruited and
randomly assigned more than 700 men with moderate to severe
symptoms and no prior prostate surgery to one of the three
MIST therapies. The men, age 50 and over, will be followed
closely for 3 to 5 years, until about July 2009, to see who
develops urinary retention, urinary tract infection or
unacceptable incontinence after treatment; who needs more
treatment; and whose symptoms don't improve by at least 30
percent after treatment.
Consortium members recruiting patients are Baylor College
of Medicine in Houston; Columbia University in New York
City; Mayo Clinic in Rochester, Minn.; Milwaukee College of
Medicine; Northwestern University in Chicago; University of
Colorado in Denver; and the University of Texas
Southwestern Medical Center in Dallas. George Washington
University Biostatistics Center in Rockville, MD, provides
overall coordination for the study and data collection and
analysis. For contact information visit www.mistbph.org.
BPH is increasingly common after age 50. Mild symptoms may
wax and wane on their own, but Nyberg predicts that as more
Baby Boomers cross into their 50s, physicians are likely to
start seeing more men who are up frequently at night using
the bathroom, a typical symptom of BPH along with
embarrassing episodes of needing to go right away
(urgency), daytime frequency, and occasional episodes of
unavoidable wetting. Over time, the progressive symptoms
associated with BPH can have a significant impact on
quality of life for the individual as well as his close
family members.
In 2000, BPH accounted for about 8 million office visits,
117,000 trips to emergency rooms, 105,000 hospital stays
and 87,400 TURPs. BPH also cost patients and insurers about
$1.1 billion, without considering nutritional supplements
and 2.2 million prescriptions, according to NIDDK's
"Urologic Diseases in America" interim compendium, released
this spring.
MIST will also compare TUNA to TUMT and seeks to identify
men best suited for each of the three therapies. Changes in
sexual function, ejaculation, bladder changes, PSA,
prostate size and shape, and ratio of various prostate
tissues; and pain before, during and after surgery, among
other parameters, will be tracked in search of
characteristics predicting likely outcome and effectiveness
of therapies.
"Having a protocol to fit the man to the therapy without
having to try each treatment along the way should translate
into lower costs and more-satisfied patients," said John W.
Kusek, Ph.D., a clinical trials expert at NIDDK.
MIST therapies are approved by FDA, but relative benefits,
risks and cost have never been compared. Further, there
have been few rigorously conducted randomized trials of the
minimally invasive surgical approaches.
"Previous studies of TUMT and TUNA haven't looked at side-
effects and symptom relief long-term but, after we've
finished MIST, men and their doctors should be a lot
smarter about the options," said Kusek.
Other support for MIST comes from Diagnostic Ultrasound,
Bothell, Washington; Urologix Inc. and Medtronic, both in
Minneapolis; Merck & Co., Whitehouse Station, New Jersey;
and Sanofi-Synthelabo Inc., New York.