TherMatrx™
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TherMatrx is offering an alternative treatment to the options listed above-microwave
thermotherapy. Clinical studies have indicated that microwave technology provides
a safe and effective treatment for BPH. It is believed that the application of
thermotherapy, or heat, to the prostate, causes changes in the prostate tissue,
thereby providing symptom relief to the patient. The TherMatrx device is the latest
generation of microwave thermotherapy devices.
The Thermatrx treatment is a simple, relatively painless way to treat BPH and
can be performed in a physician's office. This is not a surgical procedure, so
an operating room is not required. No general or spinal anesthesia will be used.
You will be completely conscious during the entire procedure and will walk out
of the office as soon as you're done.
Procedure
 After
applying a local anesthetic, your urologist will pass a small, flexible catheter
through your urethra to your bladder. This catheter contains a patented microwave
antenna, which delivers heat only to the prostate, where it is needed. This antenna
is attached tot he microwave generator of the TMx-2000. Microwave energy will
be delivered from this machine through the antennae to your prostate, where it
will heat your prostate. Heat will be applied for approximately one hour. To make
the procedure as comfortable for you as possible, you will be offered mild pain
and sedative medications prior to your treatment. You may also have the opportunity
to listen to music or watch a movie during the procedure, should you choose. Your
entire visit to the office will take approximately 2 hours, after which you will
leave the office on your own.
What can I expect after my treatment?
After your treatment, your urologist will place a small catheter, which will
drain urine from your bladder and will remain in place for a few days. During
this time, you will need to take is easy. Once your urologist determines that
the catheter can be removed, you will be free to resume you normal day-to-day
activities. A period of 6 weeks to 3 months is required for complete healing of
the prostate and noticeable improvement in your BPH symptoms. You will have the
opportunity to discuss your symptom improvement with your urologist at your follow-up
visits.
 TherMatrx™,
the pioneer in microwave thermotherapy for creating BPH, presents the TMx-2000''
transurethral microwave thermotherapy system, a truly office-based, effective,
patient friendly treatment for BPH. Clinically Proven • The TMx-2000'"
therapy is designed to cause prostatic necrosis and permanent tissue change, resulting
in improved urinary symptoms. • At one year follow up, AUA SI improved 47.1%
and peak flow rates increased 58.1% Superior Patient Tolerance • The TMx-20007"
is designed so that cooling is not required. This means that the therapy can be
run at low, safe wattage levels of 5-20W (average treatment wattage is 6W).
• Mildest recommended meds regimen
• Control button allows patient to modify treatment ramp-up as needed.
Lowest side effect profile
• PMA study indicated that side effects are minor, transitory and self-resolving.
• No urethral strictures, incontinence, loss of ejaculate or other serious
side effects have occurred. Truly in-office
• Patients require only local anesthesia (e.g., oral Toradol™ and Ativan™).
• No I.V. sedation used.
• Therapy session progresses automatically after operator set-up.
TherMatrx™ Clinical Study Overview1
Introduction and Objectives
To investigate the efficacy, safety and tolerability of the TherMatrx™
TMx-2000™ transurethral microwave thermotherapy treatment for relief of urinary
symptoms due to BPH.
Methods
200 men with symptomatic BPH were randomized 2:1, treatment vs. sham, and
treated in 7 physician offices. Prior to 3 months, patients and data coordinators
were blinded to treatment. Sham patients were allowed to crossover to active treatment
after 3 months. Patients were followed through 1 year using standard measures
of treatment outcome, including AUA symptom index (AUA SI) and urinary flow rates.
Results
At baseline, active and sham groups were statistically the same. Treatment
averaged approximately 1 hour and was well-tolerated with no patient requiring
parenteral analgesia/sedation. Treated patients showed statistically significant
improvement compared to both baseline and sham controls at 3 months. At 1 year
follow-up after active treatment, AUA SI improved from 22.5 baseline to 11.9,
a 47.1% decrease and peak flow rates increased from 8.6 to 13.6 ml/sec., a 58.1%
increase. No significant complications were observed. Side effects of treatment
were few and minor. Failure of initial voiding trial occurred in 16.8% of men
at 2-5 days; these patients were catheter-free by 9 days post-treatment. The treatment
effect was durable; in fact patients' symptoms improved over the 3 to 12 month
follow-up visits.
Conclusions
Transurethral microwave thermotherapy with the TherMatrx™ TMx-2000™
is safe, easily performed in the office with excellent patient tolerance, minor,
transitory and self-resolving side effects, and is efficacious in relieving BPH
symptoms.
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