PROSTIVA RF Therapy Overview

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• PROSTIVA RF Therapy Overview

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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 urologists office
• Procedure takes less than one hour
• Catheterization, if required, is 0-2 days on
  average
• Intended for men over age 50

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Proven RF Technology

• Nearly 100,000 patients treated worldwide
• Five-year efficacy data
• After five years
• IPSS - 55
• Qmax 29
• QOL 68
• 115º C core lesion temperature
• 75 published articles on RF therapy for BPH

Hill, et al, J Urol, 2004.
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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

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Evolution of RF Therapy
1995 - 1997
1997
2000
2003
2006

• 1992
• TUNA 3
• 5.5 - 7 min
• Lesion (manual)

ProVuDelivery System
ProVu5.5 7 min lesion
PROSTIVA2 min 20 sec lesion
Precision Plus3 min lesion
Precision4 min lesion

• First automaticsystem models7205 7600
• 18.5F/26 gaugeneedles
• Temperature measured byshield thermocouples

• 18.5F delivery system
• Highest quality opticswith proximal anddistal
  positioning
• 6 preset needle lengths
• Automatic shielddeployment
• Urethral thermocouple
• Reusable handle w/disposable cartridge

• Target temperatureof 110 C
• Hollow tip needles
• Thermocouples inshields and bothneedle tips
• Shield length 6mm
• Designed for office

• Lesion time25 faster than Precision
• Larger needle (24 gauge)provides forconsistent
  heating in alltypes of tissue

• New RF generator
• Lesion time22 faster than Precision Plus
• Target temp of 115 C
• Integrated disposable hand pieces

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• PROSTIVA RF Therapy
• System Components

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PROSTIVA RF Therapy

• Designed by Medtronic
• Target lesion temperature of 115C
• 2 min 20 second per lesion
• Easy set-up
• User interface with touch screen controls
• Platform of the future

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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

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Hand Piece Features

• Sterile, single use
• Tubing system connects to hand piece
• Tubing connects to an irrigation source which
  supplies cooling fluid during procedure

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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

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• Patient Selection and Assessment

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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.

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Patient Selection
Examples of prostate shapes that PROSTIVA RF
Therapy can treat 20-50 grams
Long Lobes
Median Lobe
Asymmetric Gland
Short Lobes
Excluding a ball valve median lobe that grows up
into bladder and obstructs opening
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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 lt34 mm or gt80 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

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• PROSTIVA RF Therapy
• Procedure Basic Steps

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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

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PROSTIVA RF Therapy Procedure

• Prepare patient
• Administer comfort control
• Measure prostate
• Determine number of treatment planes
• Treat median lobe if necessary
• Create lesions

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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

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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 cardiologists 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.
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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.
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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.
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Importance of the Return Electrode Tips for
Accurate Placement

• Return electrode has been redesigned to have a
  splitpad.
• 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.

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Return Electrode
Click image to activate video clip
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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

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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 patients skin

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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.
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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.
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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
• Inject a total of 10-12 cc on each side

Used by permission Stephen Reznicek, M.D.
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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.
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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 patients
  urethra, 20 cc of 1 lidocaine without
  epinepherine in the patients bladder, and 20 cc
  of lidocaine jelly in the patients 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.
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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.

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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.
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Measure Prostate
Click image to activate video clip
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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 clinicians sole medical judgment.

PROSTIVA RF Therapy System User Guide.
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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 clinicians sole medical judgment.

PROSTIVA RF Therapy System User Guide.
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Determining Number of Treatment Planes
Recommended guidelines
PROSTIVA RF Therapy System User Guide.
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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 clinicians
  sole medical judgment.

PROSTIVA RF Therapy System User Guide.
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Median Lobe Treatment Locations

• Recommended
• treatment locations
• Proximal (upper) end
• 10, 12, and 2 oclock
• Distal (lower) end
• 6 oclock location is for therapy at distal end

PROSTIVA RF Therapy System User Guide.
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Median Lobe Suggested Treatment

• Number of lesions based on size of median lobe

PROSTIVA RF Therapy System User Guide.
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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

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Complete System Set-up
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Complete System Set-up
Click image to activate video clip
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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.

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Initiation Lesion Procedure
Click image to activate video clip
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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.

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Irrigating Urethra
Click image to activate video clip
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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.

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References

• Parrot, Elizabeth, TUNA of the Prostate in an
  Office Setting, Urologic Nursing, Vol 23 No. 1,
  February 2003, p 33-40.
• 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
  4489-93.
• 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 1601695-1700. 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
  1591588-1594. 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,
  20041712336-2340.
• 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 [phone], x6000 or visit
  www.prostiva.com
• CAUTION Federal law (USA) restricts this device
  to sale by or on the order of a physician.