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PROSTIVA® RF Therapy
Overview
PROSTIVA® RF Therapy
• Delivers low level radio frequency
energy into the middle of the prostate
and relieves obstruction without
causing damage to the urethra
• Can be performed with a sedative and
local anesthetic in a urologist’s office
• Procedure takes less than one hour
• Catheterization, if required, is 0-2 days
on average
• Intended for men over age 50
Proven RF Technology
• Nearly 100,000 patients treated worldwide
• Five-year efficacy data
– After five years:
• IPSS
• Qmax
• QOL
- 55%
+29%
+68%
• 115º C core lesion temperature
• 75 published articles on RF therapy for
BPH
Hill, et al, J Urol, 2004.
Precise Therapy Delivery
• 360 degrees of precision to treat exactly
the area you want
• Six different needle length options to treat
varying prostate sizes and shapes
• 15 computer-monitored safety checks
Evolution of RF Therapy
1992
TUNA 3
5.5 - 7 min
Lesion (manual)
• Catheter – 22F
• 26 gauge
needles
• Manual power,
impedance and
temperature
controls
• Physician
dependent
1995 - 1997
ProVu
5.5 – 7 min
lesion
• First automatic
system models
7205 & 7600
• 18.5F/26 gauge
needles
• Temperature
measured by
shield
thermocouples
1997
ProVu
Delivery
System
• 18.5F delivery system
• Highest quality optics
with proximal and
distal positioning
• 6 preset needle lengths
• Automatic shield
deployment
• Urethral thermocouple
• Reusable handle w/
disposable cartridge
2000
2003
Precision
4 min lesion
Precision Plus
3 min lesion
PROSTIVA
2 min 20 sec lesion
• Lesion time
• New RF
• Target temperature
of 110° C
• Hollow tip needles
• Thermocouples in
shields and both
needle tips
• Shield length = 6mm
• Designed for office
25% faster than
Precision
• Larger needle
(24 gauge)
provides for
consistent
heating in all
types of tissue
2006
generator
• Lesion time
22% faster than
Precision Plus
• Target temp of
115 ° C
• Integrated
disposable hand
pieces
PROSTIVA® RF Therapy
System Components
PROSTIVA® RF Therapy
• Designed by Medtronic
• Target lesion temperature of
115°C
• 2 min 20 second per lesion
• Easy set-up
• User interface with touch screen
controls
• Platform of the future
Generator Features
Computer Monitored Safety Checks:
• Monitors urethral and prostatic
temperatures six times per second
• Controls RF power 5000 times per
second
• Measures impedance and power
50 million times per second
• Computerized graphics allow
physician to view treatment in real
time
Hand Piece Features
• Sterile, single use
• Tubing system connects to hand piece
• Tubing connects to an irrigation source
which supplies cooling fluid during
procedure
Telescope Features
• Reusable, but must be
cleaned and sterilized
before each procedure
• Allows physician to directly
view anatomical landmarks
and the needle deployment
site
• Both 0º and 15º telescopic
angles available
Patient Selection and Assessment
Indication
PROSTIVA® radio frequency therapy is
indicated for the treatment of symptoms due
to urinary outflow obstruction secondary to
benign prostatic hyperplasia (BPH) in men
over the age of 50 with prostate sizes
between 20 and 50 cm3.
Patient Selection
Examples of prostate shapes that PROSTIVA® RF Therapy can treat
20-50 grams
Long Lobes
Short Lobes
Asymmetric Gland
Median Lobe*
*Excluding a ball valve median lobe that grows up into bladder and obstructs opening
Contraindications
•
Patients with active urinary tract infection
•
Neurogenic, decompensated, or atonic bladder
•
Urethral strictures or muscle spasms that prevent insertion of the hand piece sheath
•
Bleeding disorders or patients taking anticoagulation medications unless antiplatelet
medication has been discontinued for at least 10 days
•
ASA class group V patients
•
Clinical or histological evidence of prostatic cancer or bladder cancer
•
Prostate gland <34 mm or >80 mm in transverse diameter
•
Presence of any prosthetic device in the region that may interfere with the procedure
•
Patients whose prostate has been previously treated with non-pharmacological
therapies
•
Presence of a cardiac pacemaker, implantable defibrillator, or malleable penile
implants
•
Patients with any component(s) of an implantable neurostimulation system
PROSTIVA® RF Therapy
Procedure Basic Steps
Procedure Overview
• Average actual procedure time takes 20 minutes
– Total office visit time is approximately 90 minutes
• During insertion, anatomical landmarks are located using
direct vision or a video system
• Needles and shields are deployed to pre-determined
treatment depth
• Energy is delivered by the RF generator
• Needles and shields are fully retracted and repositioned
for next lesion
PROSTIVA® RF Therapy Procedure
• Prepare patient
• Administer comfort control
• Measure prostate
• Determine number of treatment planes
• Treat median lobe if necessary
• Create lesions
Patient Preparation
• Clinicians should give their patients detailed
instructions about the procedure
– Understand risks associated with procedure
– Realistic expectations for prognosis and recovery
• Typical total time spent in office for procedure is
about 90 minutes
• Actual procedure takes about 20 minutes
Patient Instructions
• Discontinue all medications containing aspirin, ibuprofen, and
vitamin E products two weeks prior to procedure
• Stop Coumadin® approximately five days prior to procedure
with cardiologist’s approval
• Suggest either NPO after midnight or eat a light meal early in
the morning of procedure
• Take regular medications as necessary
• Wear comfortable clothing day of procedure
• Bring favorite CD to listen to during procedure
• Recommend decreasing alcohol, caffeine intake, and tobacco
use 48 hours prior to procedure
• Arrange for someone to drive you home
Parrot, Urologic Nursing 2003.
Role of Nurse
Nurse is critical to success of PROSTIVA® RF Therapy procedure
• Guides the patient
– Review and sign consent form
– Appropriate time to take oral medications for comfort control
• Keeps patient informed and relaxed throughout the entire process
• Preps the area and sets up equipment prior to procedure
• Drapes and catheterizes patient with 14 or 16 Fr catheter for purpose
of emptying bladder and instilling liquid lidocaine
• Drains bladder
• Instills topical lidocaine in bladder and urethra
• Attaches the return electrode to lumbar region of back
Parrot, Urologic Nursing 2003.
Role of Nurse
• Monitors vital signs during procedure
• Checks circulation of lower extremities since
patient is in a dorsal lithotomy position
• Assesses patient comfort
• Maintains necessary documentation as required
at institution
• Reviews post-operative instructions and
expectations
Parrot, Urologic Nursing 2003.
Importance of the Return Electrode
Tips for Accurate Placement
• Return electrode has been redesigned to have a split–pad.
• Placement and proper application of the ground pad is
critical to prevent burns and insure proper impedances.
• The split-pad return electrode should be positioned at the
lower back and securely applied to ensure complete skin
contact (no creases or bubbles should be present).
• Do not place over metal prostheses or monitoring
electrodes, scars, bony prominences, excessive hair or the
abdomen because it can affect circuit impedance.
Return Electrode
Click image to activate video clip
Return Electrode Placement
• Position return electrode
at lower back
• Return electrode cable
side should face toward
the generator
• Place horizontally across
lower portion of the small
of the back directly above
the buttocks
Secure Return Electrode
to Lower Back
• Apply at one edge and
press firmly
• Smooth to opposite edge
so the entire area is
completely attached to
the patient’s skin
Comfort Control
• Clinical trials demonstrated that the PROSTIVA®
RF Therapy procedure can be performed without
the need for general or regional (spinal)
anesthesia. Most patients require only mild
sedation, topical anesthesia, and/or prostate
block.
• Medical practice is solely the responsibility of the
individual physician and not Medtronic.
Zlotta, et al, Eur Urol 2003.
Khan, et al, J Urol 1998.
Bruskewitz, et al, J Urol 1998.
Comfort Control - Example #1
Oral therapy
•
Give combination of analgesic with sedative/hypnotic one hour prior to procedure
–
100 mg of oral Demerol®
–
10 mg of oral Valium®
Topical bladder instillation of lidocaine
•
•
•
Insert small catheter through the urethra and drain bladder
Through the catheter instill a mixture of 30 cc 2% lidocaine jelly and 30 cc 2%
injectable lidocaine (chilled, shaken)
Place clamp on penis for approximately 15 minutes, while procedure set-up and
transrectal sonography commence
Ultrasound-guided transrectal prostate block
•
•
•
•
Perform with a biplanar probe, using axial view of ultrasound
Activate the puncture guide for the probe and target the juncture between the base of
the prostate and the seminal vesicle
Inject approximately 8-10 cc of 2% plain lidocaine into the nerve plexus on each side,
with the visual goal of elevating the base of the prostate off of the rectal wall at the
juncture
Warn patient that he may experience temporary numbness in the tongue or ringing in
the ears. This may be due to the patient absorbing a small amount of the anesthetic
systemically
Used by permission – Marc Milsten, M.D.
Comfort Control - Example #2
Oral therapy
•
Give combination of oral analgesic with sedative/hypnotic
Topical bladder instillation of lidocaine
•
•
•
Empty bladder with catheter
Instill a mixture of viscous and liquid 2% lidocaine into bladder and urethra
Instill lidocaine gel into penis; place clamp on penis for approximately 20 minutes
Trans-urethral prostate block
•
•
Use either a Wolf® injection setup or a disposable Cook® or Bard® injection needle
long enough to be injected at a depth of about 1.5 cm
Inject 3 cc of 0.5% plain Marcaine® at three different locations on each side:
–
–
–
•
At the bladder neck
Midway point between bladder neck and verumontanum
Near the verumontanum posterior-lateral on each side
Used by permission – Stephen Reznicek, M.D.
Inject a total of 10-12 cc on each side
Comfort Control - Example #3
Oral therapy
•
Give combination of oral analgesic with sedative/hypnotic
–
5 mg of oral Percocet® (taken at home)
–
10 mg of oral Valium® (taken at office)
Topical bladder instillation of lidocaine
•
•
•
Empty bladder with catheter
Instill 40 cc of cooled 2% lidocaine solution into bladder and urethra
Instill lidocaine gel into urethra; place clamp on penis for approximately 20 minutes
Ultrasound-guided transrectal prostate block
•
•
•
Use longitudinal view of ultrasound
Inject 10 cc of 2% lidocaine on either side of the prostate near the seminal vesicle
Monitor blood pressure three or four times during the procedure using a pulse
oximeter
Used by permission – James Meyer, M.D.
Comfort Control - Example #4
Oral therapy
•
Give combination of oral analgesic with sedative/hypnotic
–
Hydrocodone/acetaminophen 5/500 mg tablets (taken prior to procedure)
–
10 mg of oral Valium (taken prior to procedure)
Topical bladder instillation of lidocaine
•
•
Empty bladder with catheter
Instill 10 cc of lidocaine jelly in the patient’s urethra, 20 cc of 1% lidocaine without
epinepherine in the patient’s bladder, and 20 cc of lidocaine jelly in the patient’s
rectum
Ultrasound-guided transrectal prostatic expanded regional block
•
•
Inject 1% lidocaine through a 22 gauge 8" spinal needle, injecting it at the base, apex
and mid-portion of the prostate right and left along the dorsal lateral aspect of the
prostate
Also inject and infiltrate in a lateral location right and left sides, at the level of the
membranous urethra plus the junction of the bladder neck and prostatic base
Used by permission – Robert Lindner, M.D.
Comfort Control Protocol
• Describe your comfort control protocol
• See Medtronic PROSTIVA® RF Therapy
procedural video for several comfort
control options, which can be used during
the PROSTIVA RF Therapy procedure.
Medical practice is solely the responsibility
of the individual physician and not
Medtronic.
Measure Prostate
• Determine distance from verumontanum to
bladder neck
• Perform transrectal ultrasound to
determine maximum transverse diameter
– Calculate prostate volume based on
ultrasonic measurement
– Measure transverse width in axial orientation
at level of the urethra from the TRUS
PROSTIVA® RF Therapy System User Guide.
Measure Prostate
Click image to activate video clip
Selecting Appropriate
Needle Length
• Hand piece has six preset lengths ranging from
12 to 22 mm with 2 mm increments
• Needle shields automatically retract to protect the
urethra
• Recommended guidelines based on clinical
experience for needle settings
The selection of the appropriate needle length is the clinician’s sole
medical judgment.
PROSTIVA® RF Therapy System User Guide.
Treatment Approach
• Guidelines for determining the number of treatment
planes are based on the distance from the bladder to the
verumontanum (veru):
– Ideally, a minimum of two planes should be treated provided that
the distance from the needle placement to the bladder neck and
from the needle placement to the veru remains 0.75-1.0 cm
• A treatment plane consists of delivery of energy to the
right and left lobes at the same level
Determination of the number of treatment planes is the clinician’s
sole medical judgment.
PROSTIVA® RF Therapy System User Guide.
Determining Number of
Treatment Planes
Recommended guidelines
PROSTIVA® RF Therapy System User Guide.
Median Lobe Treatment
• Visualize size and structure
• Needles should be deployed 1 cm away from the
proximal margin of the bladder neck
• Select needle length of 12 or 14 is recommended
Determination of median lobe treatment locations and appropriate
needle length is the clinician’s sole medical judgment.
PROSTIVA® RF Therapy System User Guide.
Median Lobe Treatment Locations
Recommended
treatment locations
• Proximal (upper) end
– 10, 12, and 2 o’clock
• Distal (lower) end
– 6 o’clock location is for
therapy at distal end
PROSTIVA® RF Therapy System User Guide.
Median Lobe Suggested Treatment
Number of lesions based on size of median lobe
PROSTIVA® RF Therapy System User Guide.
Initiating Lesion Procedure
• Connect and assemble
–
–
–
–
–
Telescope to the hand piece
Hand piece to the machine
Light source
Irrigation system
Camera
• Confirm RF generator system components are
ready for the lesion procedure
Complete System Set-up
Complete System Set-up
Click image to activate video clip
Initiating Lesion Procedure
• Confirm “system ready” message appears on
the screen.
• Set the hand piece needle length selector dial to
appropriate value.
• As a safety precaution, always deploy and
retract the needles to test the mechanism before
inserting them into the patient.
Initiation Lesion Procedure
Click image to activate video clip
Lesion in Progress
“Lesion in progress” message appears on screen
• Monitor urethral temperature.
– Irrigate the urethra if it reaches 43º C
• To keep the urethra cooled, irrigate with small
flushes of irrigation fluid. Use approximately
0.5-1.0 ml. of fluid.
• To drain the bladder, open the stopcock to the
aspiration position.
Irrigating Urethra
Click image to activate video clip
Lesion Complete
“Lesion complete” message appears on screen
• Fully retract the hand piece trigger mechanism.
• Move the trigger mechanism forward until it moves into
the fully retracted position. This completely retracts the
needles and shields.
• Confirm the trigger mechanism
is up and the needle retraction
shows solid white and no blue.
• Remove or reposition the
hand piece for additional
lesions.
References
•
•
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•
•
•
•
•
•
•
•
Parrot, Elizabeth, “TUNA of the Prostate in an Office Setting,” Urologic Nursing, Vol 23 No. 1, February 2003, p 3340.
PROSTIVA® RF Therapy System User Guide.
Zlotta, AR, Giannakopoulos X, Maehlum O, Ostrem T, Schulman CC, “Long-Term Evaluation of Transurethral
Needle Ablation of the Prostate (TUNA) for Treatment of Symptomatic Benign Prostatic Hyperplasia: Clinical
outcome up to five years from three centers,” Eur Urol 2003; 44:89-93.
Khan et al., “An open study on the efficacy and safety of transurethral needle ablation of the prostate in treating
symptomatic benign prostatic hyperplasia: the University of Florida experience,” J Urol, 1998; 160:1695-1700.
p.1695.
Bruskewitz et al., “A prospective, randomized 1-year clinical trial comparing transurethral needle ablation to
transurethral resection of the prostate for the treatment of symptomatic benign prostatic hyperplasia,” J Urol, 1998;
159:1588-1594. p. 1593.
Hill B, Belville W, Bruskewitz R, Issa M, Perez-Marrero R, Roehrborn C, Terris M, Naslund M, “Transurethral
Needle Ablation versus Transurethral Resection of the Prostate for the Treatment of Symptomatic Benign Prostatic
Hyperplasia: 5-Year Results of a Prospective, Randomized, Multicenter Clinical Trial,” J Urol, 2004;171:23362340.
Marcaine is a registered trademark of AstraZeneca.
Demerol is a registered trademark of Sanofi Pharmaceuticals, Inc.
Valium is a registered trademark or Roche Pharmaceuticals.
Bard is a registered trademark of Bard Medical.
Cook is a registered trademark of Cook Urological.
Wolf is a registered trademark of Wolf Medical.
For more information about PROSTIVA® RF Therapy, call (800) 643-9099, x6000; or visit www.prostiva.com
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.