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An Evidence Based Approach
Christopher Chapple
Professor of Urology
Secretary General EAU
Management of Male Benign Prostatic Enlargemen
Anatomy of the prostate
Synopsis
Management of Male Benign Prostatic Enlargement
•Terminology
•Natural History
•Management of male LUTS
•What are we treating?
•What is the evidence base?
Synopsis
• Terminology
• Natural History
• Management of male LUTS
–What are we treating?
–What is the evidence base?
Lower urinary tract symptoms (LUTS)
Abrams P et al. Urology 2003;61:37-49
Storage
symptoms
• Nocturia
• Increased daytime
frequency
• Urgency
• Urgency incontinence
Voiding
symptoms
• Slow stream
• Splitting
• Hesitancy
• Intermittency
• Terminal dribble
• Straining
Post micturition
symptoms
• Incomplete bladder
emptying
• Post micturition dribble
Prevalence of Individual LUTS
in Men and Women
Nocturia: waking to void ≥ 1 times per night
Frequency: subject feels he/she urinates too often during the day
Irwin DE, et al. Abstract presented at EAU 2006.
.
Storage Voiding
Post-
micturition
Men Women
Prevalence,%
48.5
10.8
6.7 5.5
8.4 8.8
6.7
14.2 13.4
5.5
54.2
12.8
7.3
12.6
7.1 6.3
3.9
9.8
12.2
3.1
0
10
20
30
40
50
60
Impact Of LUTS On Partners’ QoL
Worry that patient may have cancer 71%
Worry about patient’s need for surgery 66%
Social life affected by patient’s symptoms 47%
Become tired because of waking at night 42%
Worsening sex life 66%
Upset by the distress the partner suffers 66%
Sells et al. BJU Int 2000;85:440-5
What is the problem?
BPE
Enlargement
All Men
> 40 yrs
BOO
Obstruction LUTS /
Bother
Histologic
BPH
Synopsis
• Terminology
• Natural History
• Management of male LUTS
–What are we treating?
–What is the evidence base?
Natural History
• 16% of those with BPH have no change
in symptoms
• 38% were better
• Retention is uncommon
• with a follow up ranging 2.6 - 5 years
Isaacs 1990
Predictors of progression in MTOPS
Crawford ED et al. J Urol 2006;175:1422-7
Parameter Baseline value in placebo group
Qmax < 10.6 mL/s P=0.011
Age ≥ 62 years P=0.0002
Prostate volume ≥ 31 mL P<0.0001
PSA ≥ 1.6 ng/mL P=0.0009
Postvoid residual ≥ 39 mL P=0.0008
*Clinical progression defined as ≥4 point increase in IPSS, AUR, incontinence, renal
insuffiency, recurrent urinary tract infection
Risk of clinical progression* at median follow-up of 4.5 years
Net reduction of stiffness
No, I cannot get an erection
ED Increases with Age and LUTS
0
10
20
30
40
50
60
70
80
90
100
2 2 5
1812
26
46
53
6 6 11
19
32
43
53
64
16 19
31
45
41
50
52
45
50- 59 years 60- 69 years 70- 79 years
%
LUTS
Rosen R et al. Program Abstracts of the American Urological Association 2002 Annual Meeting (Abstract 500161).
Synopsis
• Terminology
• Natural History
• Management of male LUTS
–What are we treating?
–What is the evidence base?
Clinical need
• An increasing number of men aged 60 years
and over have moderate to severe LUTS.
• Prevalence increases with age, so this figure
will continue to rise
• Wide variation in clinical practice
Drivers for taking treatment decisions in
LUTS/BPO?
Risk of disease
progression
ComorbiditiesRisk of complications
Severity / type of
LUTS
QoL
Managing a chronic, progressive condition is about
maintaining quality of life
Natural History
Symptoms
Progression events
Treatment efficacy
Reduction in symptoms
Reduction in progression risk
Health-relatedQoL
Time
Side Effects of
Treatments
Synopsis
• Terminology
• Natural History
• Management of male LUTS
–What are we treating?
–What is the evidence base?
Why have Guidelines/Recommendations?
• To guide best practice
• To provide a basis for education
• To summarise consensus
• To provide a basis for medicolegal assessment
• To regulate practice and wherever possible cut
costs
We
Do
Guidelines
EAU Guidelines
30+
languages
National Societies Endorsement
www.uroweb.org/guidelines
1. The Algerian Association of Urology
2. The Argentinian Society of Urology
3. The Armenian Association of Urology
4. The Austrian Urological Society
5. The Belarusian Association of Urology
6. La Sociedad Chilena de Urología
7. La Sociedad Colombiana de Urología
8. The Cyprus Urological Association
9. The Czech Urological Society
10. The Dutch Association of Urology
11. The German Urological Association
12. The Hellenic Urological Association
13. The Hong Kong Urological Association
14. The Hungarian Urological Association
15. The Indonesian Urological Association
16. The Italian Association of Urology
17. The Kosova Urological Association
18. The Latvian Association of Urology
19. The Macedonian Association of Urology
20. The Malaysian Urological Association
21. The Polish Urological Association
22. The Portuguese Urological Association
23. The Russian Society of Urology
24. The Slovenian Urological Association
25. The Swedish Urology Association
26. The Spanish Association of Urology
27. The Taiwan Urological Association
28. The Turkish Association of Urology
29. The Ukrainian Association of Urology
Hot off the press :
30. French Association of Urology (AFU)
31. British Association of Urology (BAUS)
Clinical Guidelines
 Clinical Guidelines are becoming more influential as an important tool to
improve clinical care, unification of healthcare provision and managing resources
across Europe
 In clinical guidelines, a balanced view of risks and benefits (free of bias) is
needed, in which preferences of patients, clinical practice and healthcare policy
needs are matched with science
 Many recommendations in clinical guidelines are not well tailored to Individual
patient care needs and much work needed to impact shared decision-making
 The EAU Guidelines Office’s aim is to meet the most stringent requirements
set for clinical practice guidelines
LUTS/BPO medical treatment options
• α1-adrenoceptor (AR) antagonists
– Men with bothersome LUTS who have not developed serious complications
• 5α-reductase inhibitors (5α-RI)
– Men with bothersome LUTS who have not developed serious complications
– Only recommended for men with enlarged prostates
• Combination therapy: α1-AR antagonists + 5α-RI
– Men with bothersome LUTS who have not developed serious complications
– Men with enlarged prostates
• Combination therapy: α1-AR antagonists + PDE5?
– Incomplete dataset
• Phytotherapy
– Not recommended; lack of scientific evidence regarding efficacy and safety
Abrams P et al. J Urol 2009;181:1779-87
Management of Male Benign Prostatic Enlargement
Management of Male Benign Prostatic Enlargement
Management of Male Benign Prostatic Enlargement

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Management of Male Benign Prostatic Enlargement

  • 1. An Evidence Based Approach Christopher Chapple Professor of Urology Secretary General EAU Management of Male Benign Prostatic Enlargemen
  • 2.
  • 3. Anatomy of the prostate
  • 4. Synopsis Management of Male Benign Prostatic Enlargement •Terminology •Natural History •Management of male LUTS •What are we treating? •What is the evidence base?
  • 5. Synopsis • Terminology • Natural History • Management of male LUTS –What are we treating? –What is the evidence base?
  • 6.
  • 7. Lower urinary tract symptoms (LUTS) Abrams P et al. Urology 2003;61:37-49 Storage symptoms • Nocturia • Increased daytime frequency • Urgency • Urgency incontinence Voiding symptoms • Slow stream • Splitting • Hesitancy • Intermittency • Terminal dribble • Straining Post micturition symptoms • Incomplete bladder emptying • Post micturition dribble
  • 8. Prevalence of Individual LUTS in Men and Women Nocturia: waking to void ≥ 1 times per night Frequency: subject feels he/she urinates too often during the day Irwin DE, et al. Abstract presented at EAU 2006. . Storage Voiding Post- micturition Men Women Prevalence,% 48.5 10.8 6.7 5.5 8.4 8.8 6.7 14.2 13.4 5.5 54.2 12.8 7.3 12.6 7.1 6.3 3.9 9.8 12.2 3.1 0 10 20 30 40 50 60
  • 9.
  • 10. Impact Of LUTS On Partners’ QoL Worry that patient may have cancer 71% Worry about patient’s need for surgery 66% Social life affected by patient’s symptoms 47% Become tired because of waking at night 42% Worsening sex life 66% Upset by the distress the partner suffers 66% Sells et al. BJU Int 2000;85:440-5
  • 11.
  • 12. What is the problem? BPE Enlargement All Men > 40 yrs BOO Obstruction LUTS / Bother Histologic BPH
  • 13. Synopsis • Terminology • Natural History • Management of male LUTS –What are we treating? –What is the evidence base?
  • 14. Natural History • 16% of those with BPH have no change in symptoms • 38% were better • Retention is uncommon • with a follow up ranging 2.6 - 5 years Isaacs 1990
  • 15. Predictors of progression in MTOPS Crawford ED et al. J Urol 2006;175:1422-7 Parameter Baseline value in placebo group Qmax < 10.6 mL/s P=0.011 Age ≥ 62 years P=0.0002 Prostate volume ≥ 31 mL P<0.0001 PSA ≥ 1.6 ng/mL P=0.0009 Postvoid residual ≥ 39 mL P=0.0008 *Clinical progression defined as ≥4 point increase in IPSS, AUR, incontinence, renal insuffiency, recurrent urinary tract infection Risk of clinical progression* at median follow-up of 4.5 years
  • 16. Net reduction of stiffness No, I cannot get an erection ED Increases with Age and LUTS 0 10 20 30 40 50 60 70 80 90 100 2 2 5 1812 26 46 53 6 6 11 19 32 43 53 64 16 19 31 45 41 50 52 45 50- 59 years 60- 69 years 70- 79 years % LUTS Rosen R et al. Program Abstracts of the American Urological Association 2002 Annual Meeting (Abstract 500161).
  • 17. Synopsis • Terminology • Natural History • Management of male LUTS –What are we treating? –What is the evidence base?
  • 18. Clinical need • An increasing number of men aged 60 years and over have moderate to severe LUTS. • Prevalence increases with age, so this figure will continue to rise • Wide variation in clinical practice
  • 19. Drivers for taking treatment decisions in LUTS/BPO? Risk of disease progression ComorbiditiesRisk of complications Severity / type of LUTS QoL
  • 20. Managing a chronic, progressive condition is about maintaining quality of life Natural History Symptoms Progression events Treatment efficacy Reduction in symptoms Reduction in progression risk Health-relatedQoL Time Side Effects of Treatments
  • 21. Synopsis • Terminology • Natural History • Management of male LUTS –What are we treating? –What is the evidence base?
  • 22.
  • 23.
  • 24. Why have Guidelines/Recommendations? • To guide best practice • To provide a basis for education • To summarise consensus • To provide a basis for medicolegal assessment • To regulate practice and wherever possible cut costs
  • 26.
  • 27. National Societies Endorsement www.uroweb.org/guidelines 1. The Algerian Association of Urology 2. The Argentinian Society of Urology 3. The Armenian Association of Urology 4. The Austrian Urological Society 5. The Belarusian Association of Urology 6. La Sociedad Chilena de Urología 7. La Sociedad Colombiana de Urología 8. The Cyprus Urological Association 9. The Czech Urological Society 10. The Dutch Association of Urology 11. The German Urological Association 12. The Hellenic Urological Association 13. The Hong Kong Urological Association 14. The Hungarian Urological Association 15. The Indonesian Urological Association 16. The Italian Association of Urology 17. The Kosova Urological Association 18. The Latvian Association of Urology 19. The Macedonian Association of Urology 20. The Malaysian Urological Association 21. The Polish Urological Association 22. The Portuguese Urological Association 23. The Russian Society of Urology 24. The Slovenian Urological Association 25. The Swedish Urology Association 26. The Spanish Association of Urology 27. The Taiwan Urological Association 28. The Turkish Association of Urology 29. The Ukrainian Association of Urology Hot off the press : 30. French Association of Urology (AFU) 31. British Association of Urology (BAUS)
  • 28. Clinical Guidelines  Clinical Guidelines are becoming more influential as an important tool to improve clinical care, unification of healthcare provision and managing resources across Europe  In clinical guidelines, a balanced view of risks and benefits (free of bias) is needed, in which preferences of patients, clinical practice and healthcare policy needs are matched with science  Many recommendations in clinical guidelines are not well tailored to Individual patient care needs and much work needed to impact shared decision-making  The EAU Guidelines Office’s aim is to meet the most stringent requirements set for clinical practice guidelines
  • 29.
  • 30. LUTS/BPO medical treatment options • α1-adrenoceptor (AR) antagonists – Men with bothersome LUTS who have not developed serious complications • 5α-reductase inhibitors (5α-RI) – Men with bothersome LUTS who have not developed serious complications – Only recommended for men with enlarged prostates • Combination therapy: α1-AR antagonists + 5α-RI – Men with bothersome LUTS who have not developed serious complications – Men with enlarged prostates • Combination therapy: α1-AR antagonists + PDE5? – Incomplete dataset • Phytotherapy – Not recommended; lack of scientific evidence regarding efficacy and safety Abrams P et al. J Urol 2009;181:1779-87