Transcript PROSTIVA RF Therapy Physician Presentation

Anatomy and Physiology
Nerve Supply to Prostate
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
Importance of Nerve Supply
• Neurovascular bundles responsible for erectile
function
• Consideration for comfort control during
PROSTIVA® RF Therapy procedure
Prostate Blood Supply
• Two main arteries
supply the prostate
– Positioned at 11 and
1 o’clock
• Reduced blood
supply will impede
growth of prostate
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.
-Adrenergic Receptor Distribution in
the Lower Urinary Tract
-1D adrenoreceptors
-1A adrenoreceptors
Prostate Zones
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%
Benign Prostatic Hyperplasia
(BPH) Overview
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.
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
Quality of Life of Untreated BPH
Before PROSTIVA® RF Therapy
• I couldn’t play golf because if I’d 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 didn’t 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. I’ve 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 couldn’t
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, I’ve been able to
drop them and don’t have to take them anymore which is great. --Bobby
•
PROSTIVA RF Therapy is the best thing I ever did in my life. --Harold
Click box to activate video
This video clip is one patient’s experience only
and may not reflect other patients' experiences
Benign Prostatic Hyperplasia (BPH)
Patient Evaluation and Diagnosis
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
Patient Chooses
Noninvasive Therapy
Watchful Waiting
AUA Guideline 2003/updated 2006.
Patient Chooses
Invasive Therapy
Optional Diagnostic Tests
• Pressure flow
• Urethrocystoscopy
• Prostate ultrasound
Medical Therapy
Minimally Invasive Therapies
Surgery
Further Evaluation Warranted?
• Abnormal DRE
• History of diabetes
• Abnormal PSA
• History of pelvic surgery/
trauma
• Prior therapy for
LUTS/BPH
• Non-response to
medical therapy
• Neurologic symptoms/
disease
• Renal insufficiency
• <50 years of age
AUA Guideline 2003/updated 2006.
Questions to Ask Relative
to History
• Oral intake
– Timing
– Caffeine
– Alcohol
• Medications
affecting volume
– Diuretics
– Stool-bulking agents
• Medications affecting
voiding
– Antihistamines
– Decongestants
• Diseases
– Diabetes
– Congestive heart failure
– Neurologic
AUA Guideline 2003/updated 2006.
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.
Standard Questionnaires for Patient’s
Perception of BPH Symptoms
• AUA Symptom Score
• International Prostate Symptom Score (IPSS)
• BPH Impact Index (Bother Score)
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.
AUA Symptom Score
AUA Guideline 2003/updated 2006.
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.
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
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
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
O’Leary MP. Urology. 2000.
BPH Impact Index (Bother Score)
None
Only a little
Some
A lot
Not at all
bothersome
Bothers
me a little
Bothers
me some
Bothers
me a lot
A little of
the time
Some of
the time
Most of
the time
All of
the time
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?
3. Overall, how bothersome has any trouble
with urination been during the past month?
None of
the time
4. Over the past month, how much of the time
has any urinary problem kept you from doing
the kinds of things you would usually do?
AUA Guideline 2003/updated 2006.
Mechanism of Action
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.
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.
Current Density
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.
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 > 55° C
• Described as coagulative necrosis (dead tissue surrounded by
healthy tissue)
Physiological lesion
• Occurs at temperatures > 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.
Delivery of RF Energy
Through Needles
Pathological Lesion
Physiological Lesion
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.
Science Behind the Technology
• Based on reasonable scientific analysis,
PROSTIVA® RF Therapy works in the
following ways:
– Denervation
– Devascularization
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 neck’s
functionality.
– The system’s 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.
Alpha Receptors in the Prostate
Devascularization
• Two main arteries which supply the prostate come in
at 11 and 1 o’clock 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.
Prostate Blood Supply
PROSTIVA® RF Therapy Procedure
and 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
Mechanism of Action Animation
Click to play movie
MRI Movie Sequence
Click to play movie
Used by permission - Thayne Larson, M.D.
MRI Movie Sequence
Click to play movie
Used by permission - Thayne Larson, M.D.
MRI Lateral Lobe Lesions
Coronal View
Used by permission Thayne Larson, M.D.
MRI Lateral Lobe Lesions
Horizontal View
Used by permission Thayne Larson, M.D.
MRI Median Lobe Lesions
Coronal View
Used by permission Thayne Larson, M.D.
MRI Median Lobe Lesions
Horizontal View
Used by permission Thayne Larson, M.D.
Treatment Options for Benign
Prostatic Hyperplasia (BPH)
How do you balance the challenges of
providing a good in-office experience versus
long-term symptom relief for your patients?
What’s Your BPH Treatment Algorithm?
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.
Three Categories of
Treatment Options
Drug Therapy
Office Procedure
Surgical
-blocker
5- reductase
inhibitor
Combination
Radio Frequency
High energy TUMT
Low energy TUMT
ILC
TURP
TUIP
PVP
HoLAP
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.
Surgical – Transurethral Resection
of the Prostate (TURP)
Advantages
Disadvantages
• Availability of long-term
outcomes data
• Good clinical results
• Treats prostates <150 g
• Low retreatment rate
• Low mortality
• 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.
Surgical - GreenLight PVP™
•
•
•
•
Hospital-based procedure
Requires general anesthesia
Better for smaller prostates
TURP-like results
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
Office Procedures
• Avoid the need to take daily medication
• Avoid some of the risks and complications
associated with surgery
Office Procedures
• Radio Frequency Therapy (PROSTIVA®)
• Microwave Thermotherapy (TUMT)
• Interstitial Laser Coagulation (ILC)
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
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
PROSTIVA® RF Therapy
Indication 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.
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
Temperature Chart
Prolieve, Prostatron, Thermatrx, Targis, Indigo Instructions for Use.
PROSTIVA RF Therapy System User Guide.
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.
PROSTIVA® RF Therapy
Overview
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
• 89 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
piece
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
PROSTIVA® RF Therapy
System Components
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
• Single sterile 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
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
PROSTIVA® RF Therapy Procedure
• Prepare patient
• Administer comfort control
• Measure prostate
• Determine number of treatment planes
• Treat median lobe if necessary
• Create lesions
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.
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 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.
PROSTIVA® RF Therapy Procedure
Prostate During Procedure
Prostate Post-Procedure
MRI Image Post-Procedure
Click on picture to show MRI image
Reimbursement
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)
Clinical
Outcomes
• Would you perform the PROSTIVA® RF
Therapy procedure on your father?
• Why do you think PROSTIVA RF Therapy
works?
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, 2004;171:2336-2340
•
Zlotta, AR, Giannakopoulos X, Maehlum O, Ostrem T, Schulman CC, “LongTerm 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
•
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.
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.
O’Leary MP. LUTS, ED, QOL: alphabet soup or real concerns to aging men? Urology,
2000;56(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, 23:299-301.
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.
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, 2004;171:2336-2340.
• Nickel JC, “Long-term implications of medical therapy on benign prostatic hyperplasia end
points,” Urology, 1998;51(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, 001;57:1082-1086.
• 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, 1989;141:243-247.
• Wagner JR, Russo P, “Urologic complications of major pelvic surgery,” Semin Surg Oncol,
2000;18:216-228.
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.