An Evidence Based Approach

Christopher Chapple

Professor of Urology

Secretary General EAU

Management of Male Benign Prostatic Enlargement

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

Pre

vale

nce,

% 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?

BPEEnlargement

All Men

> 40 yrs

BOOObstruction 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 18 12

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

Comorbidities Risk 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

Healt

h-r

ela

ted

Qo

L

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