Download PROSTIVA RF Therapy - Treatment Options for BPH

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.
Treatment Options
Three categories
• Drug therapy
• In-office procedures
• Surgical procedures
Three Categories of
Treatment Options
Drug Therapy
Office Procedure
Surgical
-blocker
5- reductase
inhibitor
Combination
Radio Frequency
High energy TUMT
Low energy TUMT
TURP
TUIP
PVP
HoLAP
Drug Therapy
Advantages
• No surgery
• Effective for mild to
moderate symptoms
Drug Therapy
Disadvantages
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Lifelong commitment to therapy
Effectiveness may decrease over time
Drug therapy can cause multiple side effects
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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.
Drug Therapy
• Alpha-blockers (-blockers)
• 5-alpha Reductase Inhibitors
(5- reductase inhibitors)
-Blockers
-Blockers make urination easier by relaxing smooth muscle tissue in
the prostate and outlet of the bladder
Brand / Generic Name
Flomax® (tamsulosin)
Hytrin® (terazosin)
Cardura® (doxazosin)
Uroxatral® (alfuzosin)
Type
Selective -blocker
-blocker
-blocker
Selective -blocker
Company Name
Boehringer Ingelheim
Abbott Laboratories
Pfizer, Inc.
Sanofi-Aventis
-Blockers: Rationale and
Sites of Action
Rationale
Possible Sites of Action
• Blockade of motorsympathetic adrenergic
nerve supply to the
prostate reduces
urethral pressure
• Functional predominance
of 1-adrenoreceptors in
human prostatic muscle
• Prostatic stroma
• Detrusor, trigone, urethra
• Ganglia
• Spinal and/or supraspinal
structures
Andersson K-E et al. BJU Int. 2000,
Caine M et al. Br J Urol. 1975.
-Blockers
• Act by relaxing smooth muscle cells of the
prostate and bladder neck
– Improve urine flow
– Reduce bladder outlet obstruction
• Two categories
– Nonuroselective alpha-blockers
• Hytrin® and Cardura® target the  -1 adrenoreceptors in the
prostate
– Uroselective alpha blocker
• Flomax® targets  -1a adrenoreceptor
• Uroxatral® achieves its uroselectivity by its ability to attain
higher tissue concentration
-Blockers
Adverse effects may include
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Dizziness
Fatigue
Postural hypotension
Nasal congestion
Abnormal ejaculation
5- Reductase Inhibitors
5- reductase inhibitors suppress blood flow and the
accompanying hormones that stimulate prostate growth
Brand / Generic Name
Avodart® (dutasteride)
Proscar® (finasteride)
Type
5- Reductase Inhibitor
5- Reductase Inhibitor
Company Name
GlaxoSmith Kline
Merck & Co., Inc.
5- Reductase Inhibitors Overview
• Prevention of progression over time
• Prostate volume decreases by approximately
20% through reduction of dihydrotestosterone
(DHT) stimulation
• Slower onset of action than with -blockers
• Only used in men with prostate >40 g
McConnell JD et al. N Engl J Med, 1998.
Nickel JC et al. Urology, 1998.
5- Reductase Inhibitors
• Inhibit production of the hormone DHT (DHT
is involved with prostate enlargement)
• Have two isoforms: type 1 and type 2
– Both are found in normal prostate
– Activity of both is increased with BPH
• Drug examples
– Proscar® inhibits type 2 isoenzyme
– Avodart® inhibits both type 1 and type 2
5- reductase isoenzymes
5- Reductase Inhibitors
Adverse effects may include
– Impotence
– Decreased libido
– Decreased ejaculate volume
Hospital or Ambulatory Surgery
Center Setting
• Surgical – Transurethral Resection of
the Prostate (TURP)
• Greenlight PVP™ System
• HoLAP
Surgical – Transurethral
Resection of the Prostate (TURP)
• A urologist passes a thin
tube through the urethra
into the center of the
prostate, then scrapes away
tissue with an instrument
inserted through the tube
• Considered “Gold Standard”
for treating BPH
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:
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–
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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.
GreenLight PVP™
•
•
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Hospital-based procedure
Requires general anesthesia
Better for smaller prostates
TURP-like results
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)
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
PROSTIVA® RF Therapy
• Safe and effective
• A single office visit, treatment of
less than one hour
• Fewer side effects and adverse
events when compared to
traditional surgical treatments
• Covered by Medicare and
Medicaid in all 50 states and
many private insurance
companies
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 zerotwo days on average
• Intended for men over age 50
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.
What Side Effects are Associated with
PROSTIVA® RF Therapy?
• Possible side effects include:
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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.
Temperature Chart
Prolieve, Prostatron, Thermatrx, Targis Instructions for Use.
PROSTIVA RF Therapy System User Guide.
References
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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.
Hytrin, Flomax, Avodart, Proscar, Uroxatral prescribing information.
Lepor H et al., Proscar Peak Flow rate from “The impact of medical therapy on bother due to symptoms, quality of life and
global outcome, and factors predicting response,” J Urol, 1998.
van Kerrebroeck P, Jardin A, van Cangh P, Laval K.U., "Long-term safety and efficacy of a once-daily formulation of alfuzosin
10 mg in patients with symptomatic benign prostatic hyperplasia: open-label extension study,” Euro Urol 2002; 41:54-61.
Caine M, Raz S, Zeigler M, “Adrenergic and cholinergic receptors in the human prostate, prostatic capsule and bladder neck,”
Br J Urol, 1975;47:193-202.
Andersson K-E, “Mode of action of a1-adrenoreceptor antagonists in the treatment of lower urinary tract symptoms,” BJU
International, 2000;85(suppl 2):12-18.
McConnell JD, Bruskewitz RC, Walsh P, et al., for the Finasteride Long-term Efficacy and Safety Study Group. “The effect of
finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic
hyperplasia,” N Engl J Med, 1998;338:557-563.
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.
Debruyne FMJ, Djavan B, DeLaRosette J, et al., “Interventional therapy for benign prostatic hyperplasia. Benign Prostatic
Hyperplasia. 5th International Consultation on Benign Prostatic Hyperplasia (BPH). Eds: Chatelain C, Denis L, Foo KT, et al.
World Health Organization–International Union Against Cancer. Paris, France. June 25-28, 2000:397-421.
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.