Anatomy and Physiology

1

• Anatomy and Physiology

2
Nerve Supply to Prostate
3
Prostate Nerve Supply

• Nerve supply received from neurovascular bundles
• Innervated by autonomic and sensory nerves
• Originates from the pelvic and hypogastric fibers
• Nerves coalesce at tips of seminal vesicles to
  form the pelvic plexus

4
Importance of Nerve Supply

• Neurovascular bundles responsible for erectile
  function
• Consideration for comfort control during
  PROSTIVA RF Therapy procedure

5
Prostate Blood Supply

• Two main arteries supply the prostate
• Positioned at 11 and 1 oclock
• Reduced blood supply will impede growth of
  prostate

6
Clinical Implications for Benign Prostatic
Hyperplasia (BPH) Therapy

• Stroma (fibromuscular) predominant BPH
• Responds to ?-adrenergic blockers which exert
  their effect on the muscle
• Epithelial (glandular) predominant BPH
• Responds to androgen suppression therapy such as
  5-? reductase inhibitors, which inhibits the
  conversion of testosterone to DHT

Issa M, Contemporary Diag and Mgmt, 2005.
7
?-Adrenergic Receptor Distribution in the Lower
Urinary Tract
8
Prostate Zones
9
Transitional Zone

• Located anteriorly but surrounds the urethra
• BPH primarily affects the transitional zone
• Percentage of the prostate
• Peripheral zone - 70
• Central zone - 25
• Transitional zone - 5

10

• Benign Prostatic Hyperplasia (BPH) Overview

11
Symptomatic BPH Population

• US Prevalence 14.9 Million
• US Incidence 500,000
• Translates to 50 of men over 50
• 60 of men over 60
• 70 of men over 70
• 80 of men over 80

US Census Millennium Research, 2006 A.G.
Edwards Son, 2006.
12
Why Treat BPH?

• BPH is not cancer but it can lead to unwanted
  complications if not corrected
• Urine retention and strain on the bladder can
  lead to
• Urinary tract infections
• Bladder or kidney damage
• Bladder stones
• Incontinence
• When BPH is diagnosed and treated early, there is
  a lower risk of developing such complications

13
Quality of Life of Untreated BPH

• Before PROSTIVA RF Therapy
• I couldnt play golf because if Id get out there
  I had to stop and find a bathroom to go. --Harold
• I just had to go an awful lot five or six times
  a night. --Paul
• I didnt really mind so much the fact that it was
  difficult to start urination, but what I really
  did mind was having the leakage. --Bill
• It has an impact because first of all when you go
  into a strange store or a strange building, the
  first thing you have to zero in on is where are
  the restrooms. --Richard
• I carried a cup in the car so I could urinate.
  Ive urinated to relieve myself going 60 miles an
  hour! --Moses
• After PROSTIVA RF Therapy
• The RF Therapy has changed my life. It has
  allowed me to do things that I couldnt do
  without conditions before. --Richard
• Prior to the RF Therapy, I was on two expensive
  medications for prostate problems and one of them
  I had to take twice a day. And after the
  Therapy, Ive been able to drop them and dont
  have to take them anymore which is great.
  --Bobby
• PROSTIVA RF Therapy is the best thing I ever did
  in my life. --Harold

14
Click box to activate video
This video clip is one patients experience only
and may not reflect other patients' experiences
15

• Benign Prostatic Hyperplasia (BPH)
• Patient Evaluation and Diagnosis

16
BPH Diagnosis and Treatment Algorithm

• Initial Evaluation
• History
• DRE Focused PE
• Urinalysis
• PSA

• Presence of
• Refractory retention or any of the following
  clearly related to BPH
• Persistent gross hematuria
• Bladder stones
• Recurrent UTIs
• Renal insufficiency

AUA/IPSS Symptom Index Assessment of Patient
Bother
Moderate/Severe Symptoms (AUA/IPSS 8)
Mild Symptoms (AUA/IPSS 7) or No Bothersome
Symptoms
Surgery

• Optional Diagnostic Tests
• Uroflow
• PVR

Discussion of Treatment Options

• Optional Diagnostic Tests
• Pressure flow
• Urethrocystoscopy
• Prostate ultrasound

Patient Chooses Noninvasive Therapy
Patient Chooses Invasive Therapy
Medical Therapy
Watchful Waiting
Minimally Invasive Therapies
Surgery
AUA Guideline 2003/updated 2006.
17
Further Evaluation Warranted?

• Abnormal DRE
• Abnormal PSA
• Prior therapy for LUTS/BPH
• Non-response to medical therapy
• lt50 years of age

• History of diabetes
• History of pelvic surgery/ trauma
• Neurologic symptoms/ disease
• Renal insufficiency

AUA Guideline 2003/updated 2006.
18
Questions to Ask Relative to History

• Medications affecting voiding
• Antihistamines
• Decongestants
• Diseases
• Diabetes
• Congestive heart failure
• Neurologic

• Oral intake
• Timing
• Caffeine
• Alcohol
• Medications affecting volume
• Diuretics
• Stool-bulking agents

AUA Guideline 2003/updated 2006.
19
Optional Diagnostic Tests

• Following initial evaluation
• Uroflow
• Urinary flow-rate recording (Qmax)
• PVR
• If patient chooses invasive therapy
• Pressure flow
• Urethrocystoscopy
• Prostate ultrasound

AUA Guideline 2003/updated 2006.
20
Standard Questionnaires for Patients Perception
of BPH Symptoms

• AUA Symptom Score
• International Prostate Symptom Score (IPSS)
• BPH Impact Index (Bother Score)

21
AUA Symptom Score Index

• Seven-item questionnaire related to BPH symptoms
• Validated and reproducible
• Determines disease severity
• Documents response to therapy
• Allows standardized comparisons of symptom relief
  when evaluating treatments

AUA Guideline 2003/updated 2006.
22
AUA Symptom Score
AUA Guideline 2003/updated 2006.
23
Classification of AUA Symptom Scores

• The possible total runs from 0-35 points with
  higher scores indicating more severe symptoms.
  Scores lower than 7 are considered mild and
  generally do not warrant treatment.
• Classification ranges
• Mild (0-7)
• Moderate (8-19)
• Severe (20-35)
• Without bother or bothersome

AUA Guideline 2003/updated 2006.
24
Initial Management and Discussion Using AUA
Symptom Score

• Patients with mild symptoms (AUA symptom score
  7)
• and
• Patients with moderate or severe symptoms (AUA
  symptom score 8) who are not bothered by their
  symptoms
• Offer watchful waiting
• Reassure patient
• Reassess periodically

25
Initial Management and Discussion Using AUA
Symptom Score

• Patients with bothersome, moderate to severe
  symptoms (AUA Symptom Score 8)
• Watchful waiting
• Discuss BPH treatment options, including benefits
  and risks
• Provide patient education materials

26
International Prostate Symptom Score (IPSS)

• AUA Symptom Score Index plus additional question
  on QOL as a function of urinary symptoms
• If you were to spend the rest of your life with
  your urinary condition just the way it is now,
  how would you feel about that?
• Scale of 0 to 6 (delighted to terrible)
• Note While symptoms may be prevalent, they may
  not be troublesome

OLeary MP. Urology. 2000.
27
BPH Impact Index (Bother Score)
None Only a little Some A lot
1. Over the past month, how much physical
discomfort did any urinary problems cause you?
2. Over the past month, how much did you worry
about your health because of any urinary problems?
Not at all Bothers Bothers Bothers bothersome
me a little me some me a lot
3. Overall, how bothersome has any troublewith
urination been during the past month?
None of A little of Some of Most of All of
the time the time the time the time the time
4. Over the past month, how much of the timehas
any urinary problem kept you from doing the kinds
of things you would usually do?
AUA Guideline 2003/updated 2006.
28

• Mechanism of Action

29
Definitions

• Current - the number or amount of electrons
  flowing past a fixed point for a fixed amount of
  time
• Current density - the amount of current flowing
  per unit area of a conductor surface
• Electricity - the flow of atoms through various
  mediums such as fluids or metals that are called
  conductors. There are negatively charged
  particles inside the atoms called electrons. The
  electrons will move through a conductor if force
  or pressure is applied.

30
Definitions - continued

• Hyperthermia therapy - prostate tissue is heated
  to the range of 42? to 44? C. Tissue effect is
  temporary.
• Resistance/impedance - resistance encountered by
  the electrons as they move through a conductor.
  Resistance/ impedance is measured in ohms.
• Voltage - the force or pressure that moves
  electrons through a conductor.

31
Current Density
32
Basic Function

• The PROSTIVA RF Therapy system generator
  produces the voltage (force) necessary to move
  the electrons through the prostate tissue to the
  grounding pad.
• Electrons moving through the tissue vibrate the
  tissue causing heat from friction.
• Temperature/time
• 45 C 60 Minutes
• 55 C 20 Minutes
• 60 C 5 Minutes
• 70 C 2 Minutes

Boschef, et al. ASME, 2001.
33
Impact of Heat on Tissue
The heat generated in the tissue by the needles
can be described as forming two zones.

• Pathological lesion
• Produced when temperatures reach gt 55 C
• Described as coagulative necrosis (dead tissue
  surrounded by healthy tissue)
• Physiological lesion
• Occurs at temperatures gt 47 C
• Surrounds the pathological lesion and is
  described as the gelatinized zone
• Tissue is not killed, but damaged
• Result is injury to the tissue that is
  accompanied with inflammation and edema,
  resembling a gel

Boschef, et al. ASME, 2001.
34
Delivery of RF Energy Through Needles
RF energy disperses quickly and predictably in
tissue. The energy creates heat through cellular
friction. The heat created measures 115 C for
PROSTIVA RF Therapy at the center of the lesion
(pathological lesion). The temperature of the
heat drops between 5 to 15 C every 2 mm away
from the needles (physiological lesion).
Medtronic internal data on file.
35
Science Behind the Technology

• Based on reasonable scientific analysis,
  PROSTIVA RF Therapy works in the following ways
• Denervation
• Devascularization

36
Denervation

• Alpha-receptors have the highest concentration at
  and around the bladder neck alpha-blocker
  medications target this area.
• PROSTIVA RF Therapy is the only therapy that
  delivers lethal, controlled doses of 115 C
  temperatures precisely to this area while
  protecting the bladder necks functionality.
• The systems right angle delivery of the
  predetermined needle length and the known
  centimeter spheroid lesion size ensures this.
• The destruction of these alpha-receptor nerve
  fibers has been shown histologically.

PROSTIVA RF Therapy Model 8930 System User Guide
4-3. Perchino M. Eur Urol 1993.
37
Alpha Receptors in the Prostate
38
Devascularization

• Two main arteries which supply the prostate come
  in at 11 and 1 oclock positions.
• The growth and proliferation of the abnormal
  cells requires blood flow in order to progress.
• The interference of the blood supply will impede
  the abnormal cellular activities within the
  transitional zone of the prostate.
• This can be influenced by creating lesions or
  scar tissue by delivering RF energy to this exact
  area.

39
Prostate Blood Supply
40
PROSTIVA RF Therapy Procedureand Its Impact on
Size

• Recall that 5-? reductase inhibitors block free
  testosterone from binding to 5-? reductase
• PROSTIVA RF Therapy may kill
• 5-? reductase that is in the lesion
• The blood vessels that carry the free
  testosterone to the transitional zone
• PROSTIVA RF Therapy could decrease the size of
  the prostate

41
Mechanism of Action Animation
Click to play movie
42
MRI Movie Sequence
Click to play movie
Used by permission - Thayne Larson, M.D.
43
MRI Movie Sequence
Click to play movie
Used by permission - Thayne Larson, M.D.
44
MRI Lateral Lobe Lesions Coronal View
Used by permission - Thayne Larson, M.D.
45
MRI Lateral Lobe Lesions Horizontal View
Used by permission - Thayne Larson, M.D.
46
MRI Median Lobe LesionsCoronal View
Used by permission - Thayne Larson, M.D.
47
MRI Median Lobe Lesions Horizontal View
Used by permission - Thayne Larson, M.D.
48

• Treatment Options for Benign Prostatic
  Hyperplasia (BPH)

49

• How do you balance the challenges of providing a
  good in-office experience versus long-term
  symptom relief for your patients?

50

• Whats Your BPH Treatment Algorithm?

51
Treating BPH

• Minor symptoms usually do not require treatment.
• Moderate to severe symptoms tend to interfere
  with sleep and daily activities and usually
  require treatment.

52
Three Categories of Treatment Options
53
Drug Therapy

• Advantages
• No surgery
• Effective for mild to moderate symptoms
• Disadvantages
• Lifelong commitment to therapy
• Effectiveness may decrease over time
• Drug therapy can cause multiple side effects
• Impotence, dizziness, headaches, fatigue, and
  decreased libido
• Must take a daily pill for the rest of your life
  to maintain symptom relief and costs
  approximately 1,000 per year

http//www.drugstore.com, 2006.
54
Surgical Transurethral Resection of the
Prostate (TURP)

• Advantages
• Availability of long-term outcomes data
• Good clinical results
• Treats prostates lt150 g
• Low retreatment rate
• Low mortality

• Disadvantages
• Requires two to four days hospitalization
• Requires general or spinal anesthesia
• Potential surgical risks include
• Impotence
• Retrograde ejaculation
• Incontinence
• Infection
• Excessive blood loss

Borth CS et al, Urology, 2001.Mebust WK et al, J
Urol, 1989. Wagner JR et al, Semin Surg Oncol,
2000.
55
Surgical - GreenLight PVP

• Hospital-based procedure
• Requires general anesthesia
• Better for smaller prostates
• TURP-like results

56
Surgical - HoLAP

• Holmium laser ablation of the prostate (HoLAP)
• Performed as an outpatient procedure
• Tissue ablation is roughly equivalent to
  GreenLight PVP
• Versatility of performing across multiple
  specialties and treating other urology conditions
  including strictures, tumors and stones

57
Office Procedures

• Avoid the need to take daily medication
• Avoid some of the risks and complications
  associated with surgery

58
Office Procedures

• Radio Frequency Therapy (PROSTIVA)
• Microwave Thermotherapy (TUMT)
• Interstitial Laser Coagulation (ILC)

59
Office Procedure - TUMT

• Microwaves used to heat and destroy excess
  prostate tissue
• Procedure takes about one hour
• Some require 2 to 14 days of catheterization
  which can result in urinary tract infection

60
Office Procedure - ILC

• Laser energy coagulates obstructing tissue of the
  enlarged prostate gland
• The tissue that is destroyed is absorbed by the
  body and BPH symptoms decrease over time
• May require extended post-procedural
  catheterization which can result in higher rates
  of urinary tract infection
• Procedure takes less than one hour
• Requires 5 to 14 days of catheterization

61
PROSTIVA RF TherapyIndication for Use

• 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.

PROSTIVA RF Therapy System User Guide.
62
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

63
Temperature Chart
Prolieve, Prostatron, Thermatrx, Targis, Indigo
Instructions for Use. PROSTIVA RF Therapy System
User Guide.
64
What Side Effects are Associated with PROSTIVA
RF Therapy?

• Possible side effects include
• Obstruction
• Catheterization (for urinary retention)
• Bleeding/blood in urine
• Pain/discomfort
• Urgency to urinate
• Increased frequency of urination
• Urinary tract infection
• Patients may also experience a minor burning
  sensation when urinating for one to two weeks
  following the treatment
• Compared to traditional surgical treatments,
  fewer side effects and adverse events

PROSTIVA RF Therapy System User Guide.
65

• PROSTIVA RF Therapy Overview

66
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
• 89 published articles on RF therapy for BPH

Hill, et al, J Urol, 2004.
67
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

68
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 piece

69
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

70

• PROSTIVA RF Therapy
• System Components

71
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

72
Hand Piece Features

• Single sterile use
• Tubing system connects to hand piece
• Tubing connects to an irrigation source which
  supplies cooling fluid during procedure

73
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

74

• Patient Selection and Assessment

75
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
76
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

77

• PROSTIVA RF Therapy
• Procedure Basic Steps

78
PROSTIVA RF Therapy Procedure

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

79
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 procedure.
  Medical practice is solely the responsibility of
  the individual physician and not Medtronic.

80
Treatment Approach

• Guidelines for determining the number of
  treatment planes are based on the distance from
  the bladder to the verumontanum
• 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.
81
Determining Number of Treatment Planes
Recommended guidelines
PROSTIVA RF Therapy System User Guide.
82
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.
83
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.
84
PROSTIVA RF Therapy Procedure
85
Prostate During Procedure
86
Prostate Post-Procedure
87
MRI Image Post-Procedure
Click on picture to show MRI image
88

• Reimbursement

89
Reimbursement Status

• PROSTIVA RF Therapy coverage
• Medicare in all 50 states
• Many private pay and managed care insurance
  companies
• Most patients will be responsible for a
  deductible and/or co-payment
• Medicare reimburses physicians for performing the
  PROSTIVA RF Therapy procedure in their offices
  (there is a site of service differential)

90

• Clinical

91
Outcomes

• Would you perform the PROSTIVA RF Therapy
  procedure on your father?
• Why do you think PROSTIVA RF Therapy works?

92
PROSTIVA RF Therapy Long-term Durability

• Can you speak to long-term durability?
• 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
• 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
• Boyle P, Robertson C, Vaughan E D, Fitzpatrick J,
  A Meta-Analysis of Trials of Transurethral
  Needle Ablation for Treating Symptomatic Benign
  Prostatic Hyperplasia, British Journal of
  Urology Intl, 2004 94 83-88.
• AUA Guidelines 2004, Management of Benign
  Prostatic Hyperplasia Diagnosis and Treatment
  Recommendations Chapter 1, page 27.

93
References

• Issa M, Marshall F. Contemporary Diagnosis and
  Management of Diseases of the Prostate. 3rd ed.
  Newtown, Pa Handbooks in Healthcare Co 2005.
• American Urological Association Education and
  Research, Inc. AUA Guideline 2003/Updated 2006.
• OLeary MP. LUTS, ED, QOL alphabet soup or real
  concerns to aging men? Urology, 200056(suppl
  5A)7-11.
• Boschef, et al., In vitro assessment of the
  efficacy of thermal therapy in human benign
  prostate hyperplasia, ASME, 2001 Nov 2001.
• PROSTIVA RF Therapy Model 8930 System User Guide,
  4-3.
• Perchino M, et al., Does transurethral
  thermotherapy induce a long-term alpha blockade?
  An immunohistochemical study, Eur Urol, 1993,
  23299-301.
• Larson, Thayne. Institute of Medical Research
  and Lance Mynderse, M.D., Mayo Clinic. MRI
  study of 12 patients with average age of 64,
  treatment focus on bladder neck and lateral
  lobe, 2006 Medtronic RF Therapy Study.
• http//www.drugstore.com. Accessed March 7,
  2006.
• PROSTIVA RF Therapy System User Guide. Safety
  information from System User Guide is available
  at www.prostiva.com.

94
References

• 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.
• Nickel JC, Long-term implications of medical
  therapy on benign prostatic hyperplasia end
  points, Urology, 199851(suppl 4A)50-57.
• Borth CS, Beiko DT, Nickel JC, Impact of medical
  therapy on transurethral resection of the
  prostate a decade of change, Urology,
  001571082-1086.
• Mebust WK, Holtgrewe HL, Cockett ATK, Peters PC,
  for the Writing Committee. Transurethral
  prostatectomy immediate and postoperative
  complications. A cooperative study of 13
  participating institutions evaluating 3,885
  patients, J Urol, 1989141243-247.
• Wagner JR, Russo P, Urologic complications of
  major pelvic surgery, Semin Surg Oncol,
  200018216-228.
• 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.