Treatment Options for Benign Prostatic Hyperplasia BPH

1

• Treatment Options for Benign Prostatic
  Hyperplasia (BPH)

2

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

3

• Whats Your BPH Treatment Algorithm?

4
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.

5
Treatment Options

• Three categories
• Drug therapy
• In-office procedures
• Surgical procedures

6
Three Categories of Treatment Options
7
Drug Therapy

• Advantages
• No surgery
• Effective for mild to moderate symptoms

8
Drug Therapy

• 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.

9
Drug Therapy

• Alpha-blockers (a-blockers)
• 5-alpha Reductase Inhibitors (5-a reductase
  inhibitors)

10
a-Blockers

• ?-Blockers make urination easier by relaxing
  smooth muscle tissue in the prostate and outlet
  of the bladder
• Brand / Generic Name Type Company Name
• Flomax (tamsulosin) Selective a-blocker Boehringe
  r Ingelheim
• Hytrin (terazosin) a-blocker Abbott Laboratories
• Cardura (doxazosin) a-blocker Pfizer, Inc.
• Uroxatral (alfuzosin) Selective
  a-blocker Sanofi-Aventis

11
a-Blockers Rationale andSites of Action

• Rationale
• Blockade of motor- sympathetic adrenergic nerve
  supply to the prostate reducesurethral pressure
• Functional predominance of a1-adrenoreceptors in
  human prostatic muscle

• Possible Sites of Action
• 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.
12
a-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

13
a-Blockers

• Adverse effects may include
• Dizziness
• Fatigue
• Postural hypotension
• Nasal congestion
• Abnormal ejaculation

14
5-a Reductase Inhibitors

• 5-? reductase inhibitors suppress blood flow and
  the accompanying hormones that stimulate prostate
  growth
• Brand / Generic Name Type Company Name
• Avodart (dutasteride) 5-a Reductase
  Inhibitor GlaxoSmith Kline
• Proscar (finasteride) 5-a Reductase Inhibitor
  Merck Co., Inc.

15
5-a 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 a-blockers
• Only used in men with prostate gt40 g

McConnell JD et al. N Engl J Med, 1998.Nickel JC
et al. Urology, 1998.
16
5-a 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

17
5-a Reductase Inhibitors

• Adverse effects may include
• Impotence
• Decreased libido
• Decreased ejaculate volume

18
Hospital or Ambulatory Surgery Center Setting

• Surgical Transurethral Resection of the
  Prostate (TURP)
• Greenlight PVP System
• HoLAP

19
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

20
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.
21
GreenLight PVP

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

22
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

23
Office Procedures

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

24
Office Procedures

• Radio Frequency Therapy (PROSTIVA)
• Microwave Thermotherapy (TUMT)

25
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

26
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

27
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 zero-two days on
  average
• Intended for men over age 50

28
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.
29
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.
30
Temperature Chart
Prolieve, Prostatron, Thermatrx, Targis
Instructions for Use. PROSTIVA RF Therapy System
User Guide.
31
References

• 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 4154-61.
• Caine M, Raz S, Zeigler M, Adrenergic and
  cholinergic receptors in the human prostate,
  prostatic capsule and bladder neck, Br J Urol,
  197547193-202.
• Andersson K-E, Mode of action of
  a1-adrenoreceptor antagonists in the treatment of
  lower urinary tract symptoms, BJU International,
  200085(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,
  1998338557-563.
• 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.
• 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 OrganizationInternational
  Union Against Cancer. Paris, France. June
  25-28, 2000397-421.
• 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, 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.