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Diagnosis and Management of Benign Prostatic Hyperplasia

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Title: Diagnosis and Management of Benign Prostatic Hyperplasia


1
Diagnosis and Management of Benign Prostatic
Hyperplasia (BPH)
  • Michael Naslund M.D.

2
Anatomy of BPH
Normal
BPH
BLADDER
Hypertrophied detrusor muscle
PROSTATE
URETHRA
Obstructed urinary flow
Roehrborn CG, McConnell JD. In Walsh PC et al,
eds. Campbells Urology. 8th ed. Philadelphia,
Pa Saunders 20021297-1336.
3
Top 10 Diagnosed Diseases in Men Age 50 Years
Issa MM et al. Am J Manag Care.
200612(suppl)S83S89.
4
Diagnosis of Bladder Outlet Obstruction
5
Lower Urinary Tract Symptoms (LUTS)
  • Obstructive Symptoms
  • Hesitancy
  • Weak stream
  • Straining to pass urine
  • Prolonged micturition
  • Feeling of incomplete bladder emptying
  • Urinary retention
  • Irritative Symptoms
  • Urgency
  • Frequency
  • Nocturia
  • Urge incontinence

Kirby RS et al. Benign prostatic hyperplasia.
Health Press, 1995.
6
Consequences
Problems
LUTS1,2
Bothersome Interference with daily activities and
sexual function

BPH (Benign Prostatic Hyperplasia)
AUR Surgery Nonfunctioning bladder UTI Stones Rena
l failure
BOO3(Bladder Outlet Obstruction)
1. AUA Practice Guidelines Committee. J Urol.
2003170530-547. 2. Rosen R et al. Eur Urol.
200344637-649. 3. Lepor H, Lowe FC. In Walsh
PC et al, eds. Campbells Urology. 8th ed.
Philadelphia, Pa Saunders 20021337-1377.
7
Multinational Survey of the Aging Male (MSAM-7)
  • Objectives
  • Evaluate sexual function and prevalence of LUTS
    in a representative population of men aged 50-80
    years
  • Patients
  • 14,254 men aged 50-80 years in 7 countries
    United States, United Kingdom, France, Germany,
    Italy, Spain, Netherlands
  • Methods
  • Postal questionnaire (validated scales)
  • IPSS, Dan-PSSsex, IIEF, demographic
    characteristics, comorbidity factors

Rosen R. Multinational Survey of the Aging Male
(MSAM-7). Presented at the Annual Meeting
of the American Urological Association May
26, 2002 Orlando, Fla.
8
MSAM-7 Older Men Are Still Sexually Active
92
83
83
100
65
80
60
of men with sexual activity in the last 4 weeks
40
20
0
50-59
60-69
70-79
Total
Age
  • Sexually activity Any activity that the
    participant considered sexual

Rosen R. Multinational Survey of the Aging Male
(MSAM-7). Presented at the Annual Meeting
of the American Urological Association May
26, 2002 Orlando, Fla.
9
MSAM-7 Sexual Activity Declines With Increasing
Severity of LUTS Independent of Age
10
9
8
7
6
Average Number of Sexual Activities per Month
5
4
3
2
1
0
50-59 y
60-69 y
70-79 y
Among total sample.
Rosen R. Multinational Survey of the Aging Male
(MSAM-7). Presented at theAnnual Meeting of the
American Urological Association May 26, 2002
Orlando, Fla.
10
MSAM-7 Erectile Function DeclinesWith
Increasing Severity of LUTS Independent of Age
Average score on a scale from 1 to 30 (6
questions) measured by IIEF Per question 1
Negative to 5 Positive
30
LUTS
20
None
Average Erectile Function Score(IIEF)
Mild
Moderate
Severe
10
0
50-59 y
60-69 y
70-79 y
Base Men sexually active/sexual intercourse
during past 4 weeks, as measured by IIEF. Rosen
R. Multinational Survey of the Aging Male
(MSAM-7). Presented at the Annual Meeting of the
American Urological Association May 26, 2002
Orlando, Fla.
11
Why Does BPH Progress In Some But Not All Men?
12
Risk Factors for BPH Progression
  • Age 50 years or older
  • AUA-SI score gt 7
  • Enlarged prostate ( 30-40 ml.)
  • PSA 1.5

McConnell JD et al. N Engl J Med.
20033492387?2398. Roehrborn CG et al.
Urology.199953473?480.
13
Prevalence of Histologic BPH Increases With Age
Roehrborn CG, McConnell JD. In Walsh PC et al,
eds. Campbells Urology. 8th ed. Philadelphia,
Pa Saunders 20021297-1336.
14
Risk Factors for BPH Progression
  • Age 50 years or older
  • AUA-SI score gt 7
  • Enlarged prostate ( 30-40 ml.)
  • PSA 1.5

McConnell JD et al. N Engl J Med.
20033492387?2398. Roehrborn CG et al.
Urology.199953473?480.
15
Relationship Between Prostate Volume and Serum
PSA in Men with BPH
65
75
60
70
65
55
60
50
55
50
Prostate volume (mL)
45
Age (years)
40
35
30
1
2
3
4
5
6
7

Serum PSA (ng/mL)
Roehrborn CG et al. Urology. 199953581589.
16
Cumulative Incidence of Progression by Baseline
PSA
PSA (ng/mL)
6
P lt 0.0001
lt 1.4
5
1.4?3.9
P 0.0003
? 4.0
4
Rate per 100 person-years
3
2
P lt 0.0001
1
0
Progression
gt 4-point rise in AUA-SI score
AUR
McConnell JD et al. N Engl J Med.
20033492387?2398.
17
Treatment Options for BPH
  • Watchful waiting
  • Pharmacologic therapy
  • alpha-adrenergic blockers (for BPH symptoms)
  • 5-ARIs
  • combinations of the above
  • Minimally invasive therapy
  • TUMT
  • TUNA
  • ILC
  • Less invasive surgery
  • Laser vaporization
  • Major surgery
  • TURP (gold standard)
  • TUIP
  • Open surgery (prostatectomy)

5-ARIs5-alpha-reductase inhibitors ILCinterstiti
al laser coagulation (also known as
LITT) TUIPtransurethral incision of prostate
TUMTtransurethral microwave thermotherapy TUNAt
ransurethral needle ablation TURPtransurethral
resection of prostate AUA Practice Guidelines
Committee. J Urol. 2003170530-547.
18
Watchful Waiting/Active Surveillance
  • Patient is followed annually but receives no
    active intervention for symptoms1
  • Appropriate option for patients with mild
    symptoms, and for many with moderateto severe
    symptoms if they are not bothered1
  • AUA Practice Guidelines Committee. J Urol.
    2003170530-547.
  • Brookes ST et al. BMJ. 2002341059-1061.

19
Pharmacologic Therapy For BPH
  • ?-adrenergic blockers
  • 5?-reductase inhibitors
  • Combination therapy

20
Distribution of Alpha Receptors in the Prostate
and Bladder
21
Treatment Options Alpha Blockers
  • Mechanism1,2
  • Relax smooth muscle in bladder neck and prostate
  • Improve urinary flow (Qmax) and bothersome
    symptoms
  • Agents indicated for symptomatic BPH include1
  • Alfuzosin
  • Doxazosin
  • Silodosin
  • Tamsulosin
  • Terazosin

BPH Benign Prostatic Hyperplasia
1. Kaplan S. Weill Medical College of Cornell
University Reports on Mens Urologic Health.
20061(1)1-8.
2. McConnell J, et al. N Engl J Med.
20033492387-2398.


22
AUA Guidelines
  • Alfuzosin, doxazosin, tamsulosin and terazosin
    are appropriate treatment options for patients
    with LUTS secondary to BPH.
  • The adverse event profile appears slightly
    different between the four alpha-blocking agents

American Urological Association Research and
Education Inc. BPH Guidelines. April
2003.Please see accompanying Uroxatral full
prescribing information.
23
Differential Effects of ?-Blockerson Blood
Pressure
  • Doxazosin1 and Terazosin2
  • Indicated for the treatment of hypertension
  • Initiated at a low dose to avoid a first-dose
    phenomenon(ie, syncope)3
  • Alfuzosin4, Tamsulosin5 and Silodosin
  • Not indicated for the treatment of hypertension
  • Initial dose titration not required

1. CarduraR (doxazosin mesylate tablets)
Prescribing Information, Pfizer Inc. 2 HytrinR
(terazosin hydrochloride) Prescribing
information, Abbott Laboratories. 3. Vallencien
G. Urology. 199954773-775. 4. UroxatralR
(alfuzosin HCl extended release tablets)
Prescribing Information, Sanofi-Synthelabo Inc.
5. FlomaxR (tamsulosin hydrochloride)
Prescribing Information, Boehringer Ingelheim
Pharmaceuticals Inc.
24
5?-Reductase Inhibitors
25
Two 5?-Reductase (5AR) Isoenzymes Convert
Testosterone to DHT
Bartsch G et al. Eur Urol. 200037367?380.
26
Near Complete DHT Suppression Requires Inhibiting
Both 5AR Isoenzymes
Dutasteride
Finasteride
Type II 5AR
Testosterone
DHT
Type I 5AR
Prostatevolume reduced
Dutasteride
Bartsch G et al. Eur Urol. 200037367?380.
27
PSA Is Reduced in a Predictable Manner with
Dutasteride
15.8
10.7
6.8
5.5
2.8
Placebo
2.2
9.2
Mean change in serum PSA ()
35.7
Dutasteride
43.5
48.6
50.5
52.4
1
6
9
12
15
21
18
24
3
Baseline
Month
Data on file, GlaxoSmithKline.
28
Using PSA To Detect Cancer-Related PSA Changes In
Patients On 5-ARIs
?
  • Establish new baseline PSA after 12 months of
    -ARI treatment
  • Subsequent increases in PSA may indicate
    noncompliance, prostate cancer, or other
    prostate-related conditions that may need
    evaluation

29
Rises in PSA after 6 Months on 5-ARI May Be
Indicative of Prostate Cancer
Graph depicts 5-ARI treated patients only
Data on File GlaxoSmithKline
30
REDUCE Trial Study Design?
2-year biopsy (Visit 6)
4-year biopsy (Visit 10)
Randomization (Visit 2)
Study Entry (Screen Visit 1)
0
24
48
-1
52
-7
Month
4-year treatment period with dutasteride 0.5 mg
daily or placebo
6-month eligibility window
4-wk Placebo run-in
4-month Follow-up
For-cause biopsies may occur here
Entry biopsy
NOTE All biopsies centrally evaluated
Mandatory Transrectal Ultrasound (TRUS)-guided
10 core biopsies Andriole G et al. J Urol.
200417213141317.
31
Preliminary Results from the REDUCE Trial
(Analysis Ongoing)?
  • Primary Endpoint 23 reduction in
    biopsy-detectable prostate cancer with
    dutasteride vs. placebo over 4 years (Plt0.0001)
  • Secondary Endpoint Incidence of high grade
    tumors over 4 years
  • Gleason score 7-10 6.7 for dutasteride vs.
    6.8 for placebo (P0.81)
  • Gleason score 8-10 0.9 for dutasteride vs.
    0.6 for placebo (P0.15)

Data on file, GlaxoSmithKline
32
Minimally Invasive/Surgical Treatment Options For
BPH
33
Principles of Thermotherapy
  • Blood supply of BPH adenoma more fragile than
    prostate capsule
  • Adenoma can be heated to cause necrosis
  • Capsule protected by better blood flow
  • Tissue necrosis, nerve damage/destruction lead to
    improved voiding symptoms

34
Anatomy of BPH
Normal
BPH
BLADDER
Hypertrophied detrusor muscle
PROSTATE
URETHRA
Obstructed urinary flow
Roehrborn CG, McConnell JD. In Walsh PC et al,
eds. Campbells Urology. 8th ed. Philadelphia,
Pa Saunders 20021297-1336.
35
  • Radio Frequency Generator
  • Monitors temperature of urethra and prostate 50
    times per second with Precision Reassurance
    Technology
  • Computerized graphics allow physician to view
    treatment in real time

36
  • Cartridge and Needle Deployment

Disposable Cartridge and Reusable Handle
Dual Deployment of Needles and Shields
37
Schematic of TUNA Procedure
Completed Procedure with 8 Lesions
Creation of a Lesion
38
Transurethral Microwave Therapy
  • Microwave energy causes tissue necrosis
  • Cooling channels in catheter cool urethra

39
Interstitial Laser Therapy
  • Lesions created throughout prostate
  • Laser fiber alignment critical
  • Median lobe can be treated

40
Anesthesia Options
  • Local (lidocaine jelly)
  • Oral narcotics
  • Prostate block
  • I.V. sedation

41
Treatment Results After Thermotherapy
  • Most patients see improvement in symptoms
  • Results not as consistent as TURP
  • Bladder function important
  • Long term results of TUNA, TUMT and ILT are
    similar

42
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43
PVP Laser Prostatectomy
  • Vaporizes tissue
  • Minimal bleeding
  • No catheter post-op

44
PVP Laser Removes Tissue
  • Opens bladder neck
  • Cavity similar to TURP
  • Improvement in symptoms similar to TURP
  • Less impotence than TURP, other morbidity similar

45
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46
Should PSA Testing Be Done?If So, How Should it
Be Done?
47
How Often Should PSA Be Tested?
  • All men should get PSA age 40
  • If PSA gt1.0, check annually
  • If PSA lt1.0, check annually at age 50
  • Annually at age 40 for A.A. or fam. hx.
  • Stop testing in mid to late 70s
  • Dont test if life expectancy lt 10 yrs.

48
PSA and the Risk of Prostate Cancer
42-64
20-30
20-30
J Urol 1992 147817-821 J Urol 1998
1601734-38 Intern Med 1997 126480-4
49
Prevalence of PCa in Men With PSA lt 4.0
NEJM 350 2259, 2004
50
Is It Necessary/Desirable to Detect on-Palpable
Cancer When PSA is lt 4.0?
  • 15-25 of men gt50 have autopsy PCa
  • 90 of men 50-90 have PSA lt 4.0
  • More occult PCa at lower PSA levels
  • Outcomes no better for PSA lt 4 vs 4-10
  • With regular PSA testing, non-curable dx. uncommon

51
Age-Specific PSA for Different Races
JAMA 270 860, 1993 NEJM 335 304, 1996
BJU 75 347, 1995
52
Causes of Elevated PSA
53
Causes of Elevated PSA
  • Cancer
  • BPH
  • Prostatitis
  • Infarct, retention

54
Prostatitis Can Elevate PSA
  • Assess voiding symptoms
  • Analyze previous PSA results
  • Consider antibiotic/anti-inflammatory trial
  • If still abnormal, do biopsy

55
Prostate Infarct Elevates PSA
  • Common in enlarged glands
  • Asymptomatic
  • Infarct can cause retention
  • Retention increases risk of carcinoma

56
Effect of Ejaculation on PSA
  • PSA does rise after ejaculation
  • Usually not clinically significant
  • Ideally, should abstain for _at_ 72 hrs.
  • Consider for slight elevations

57
Causes of Elevated PSA Iatrogenic
  • DRE- vs - prostate massage
  • Colonoscopy, catheterization
  • Prostate ultrasound/biopsy
  • Bx - 6.5 x in 5 min, 7.9 ng/ml in 24 hr.

58
Follow-up Time for PSA Elevation
  • Half-life 2.2 - 3.2 days
  • PSA is baseline 14-17 days after bx.
  • PSA is baseline 4- 6 wks. after acute prostatitis
  • In general, repeat PSA after 30 days

59
Detection of Cancer with PSA
60
Elevated PSA Is Not Specific for Cancer
  • Cancer
  • BPH
  • Prostatitis
  • Infarct, retention

61
PSA Velocity
  • Need 3 PSA values over 2 yrs.
  • Results not specific
  • Increase gt 0.75 suspicious for men gt60
  • Increase gt 0.50 suspicious for men lt 60

62
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63
Usefulness of Free-Total PSA
  • Improves specificity if PSA 4-10
  • Improves sensitivity if PSA lt 4.0
  • Ratio 25 suggests benign disease
  • Ratio 12 suggests malignancy

64
uPM3 Genetic Urine Test For PCa
  • uPM3 detects PCA3 gene in voided urine
  • Requires vigorous prostate massage
  • Sensitivity 67, specificity 89
  • Accuracy 443 tx.- uPM3- 81, PSA 38

65
EPCA-2 for PCa Detection
  • Measures nuclear matrix protein which is elevated
    in Pca
  • Sensitivity/specificity gt 90
  • Well defined cutpoint between PCa and BPH
  • Not yet FDA approved

66
Does PSA Testing Lower Cancer-Specific Mortality?
67
Increased Risk of Death From Prostate Cancer
NEJM 3601320, 2009
68
Number of Prostate Cancers and Prostate Cancer
Deaths
NEJM 360 1310, 2009
69
Dying With PCa is Not Pleasant
  • Incontinence
  • Sexual dysfunction
  • Bone pain, fractures
  • Metabolic syndrome
  • Hormone Rx induced dementia
  • Urinary symptoms, bleeding
  • Cachexia

70
PSA Testing Makes Sense For Relatively Young,
Healthy Men
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