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Dr. Boyke Subali, SpU RSU. A. Wahab Sjahranie - Samarinda.

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Presentation on theme: "Dr. Boyke Subali, SpU RSU. A. Wahab Sjahranie - Samarinda."— Presentation transcript:

1 Dr. Boyke Subali, SpU RSU. A. Wahab Sjahranie - Samarinda

2 Sub Tittle 2

3 Roehrborn CG, et al.International Journal of Impotence Research.2008; 20: S11–S18

4 Garraway WM, et al. Br J Gen Pract. 1993;43(373):

5 Yes! When should BPH be considered as a disease? Bothersome symptoms? When should BPH be considered as a disease?

6 Benign prostatic hyperplasia (BPH) is a pathologic process that contributes to, but is not the sole cause of, lower urinary tract symptoms (LUTS) in aging men Benign prostatic hyperplasia is defined histologically as a disease process characterized by stromal and epithelial cell hyperplasia. Originates from transition zone 6 AUA Guideline. J Urol.2003;170: Roehrborn CG. International Journal of Impotence Research.2008;20:S11–S18 Lee KL et al. J Urol 2004;172:1784–1791

7 7 Hypertrophied detrusor muscle Obstructed urinary flow Prostate Bladder Urethra Normal BPH Enlargement of the prostate Adapted from Kirby RS et al. Benign Prostatic Hyperplasia. Health Press, Oxford, 1999 available at:

8 DHT-androgen receptor complex Growth factors Unbalanced DHT T 5α-reductase types 1 and 2 Serum DHT Serum testosterone (T) Prostate cell Increased cell growth Cell death 8 Adapted from Kirby RS, McConnell. Benign Prostatic Hyperplasia. Health Press Ltd, 1999

9 BPH = Benign Prostatic Hyperplasia  Histological: stromoglandular hyperplasia May be associated with  Clinical: presence of bothersome LUTS 2  Anatomical: enlargement of the gland (BPE = Benign Prostatic Enlargement) 2  Pathophysiological: compression of urethra and compromise of urinary flow (BOO = Bladder Outlet Obstruction) 2 Nordling J et al. In: Chatelain C et al, eds. Benign Prostatic Hyperplasia. Plymouth, UK: Health Publication Ltd; 2001: Histological BPH All Men >40 y ` BOO Obstruction BPE Enlargement LUTS/ Bother

10 Voiding symptoms, caused by an enlarged prostate  Weak urinary stream  Prolonged voiding  Abdominal straining  Hesitancy  Intermittency  Incomplete bladder emptying  Terminal and post-void dribbling BPH symptoms may include: Storage symptoms, which can result from enlarged prostate or overactive bladder (OAB)  Frequency  Nocturia  Urgency  Incontinence  LUTS are not specific to BPH – not all men with LUTS have BPH and not all men with BPH have LUTS Associated symptoms of BPH include:  Dysuria  Haematuria  Haematospermia

11 11 Medical history Symptom score Physical examination (incl. DRE) PSA Creatinine measurement* Urinalysis Flow rate** Post-void residual volume** EAU BPH guidelines. Madersbacher S et al. Eur Urol 2004; 46: 547–554 AUA Practice Guidelines Committee. J Urol 2003; 170: 530–547 *Not recommended by the AUA guidelines ** Considered optional in the AUA guidelines

12 Evaluating symptom severity is an important part of the initial assessment  Symptom severity is probably best assessed through the use of a validated symptom score  The internationale standard instrument is the International Prostate Symptom Score (IPSS) The IPSS comprises of 8 questions:  7 questions about the severity of symptoms  These are identical to the 7 questions of the AUA Symptom Index*  1 question on global quality of life 12 EAU BPH guidelines. Madersbacher S et al. Eur Urol 2004; 46: 547–554 AUA Practice Guidelines Committee. J Urol 2003; 170: 530–547 *The AUA guidelines recommend use of the AUA-SI (7 questions)

13 13 Over the past month, how often have you…Not at allLess than 1 time in 5 Less than half the time About half the time More than half the time Almost always YOUR SCORE 1. …had a sensation of not emptying your bladder completely after you finish urinating? …had to urinate again less than two hours after you finished urinating? …stopped and started again several times when you urinated? …found it difficult to postpone urination? …had a weak urinary stream? …had to push or strain to begin urination? Over the past month, how many times did you most typically get up to urinate from the time you went to bed at night until the time you got up in the morning? NoneOnceTwice3 times4 times5 times or more TOTAL 8. QUALITY OF LIFE DUE TO URINARY SYMPTOMS If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that? DelightedPleasedMostly satisfied Mixed – about equally satisfied & dissatisfied Mostly dissatisfied UnhappyTerrible

14 14 Total IPSSSymptom severity 0–7Mild 8–19Moderate  20 Severe EAU BPH guidelines. Madersbacher S et al. Eur Urol 2004; 46: 547–554

15 Physical examination during the initial assessment of a man with LUTS suggestive of BPH should include:  Focused neurological examination  Digital rectal examination (DRE)  To help evaluate prostate size  To help exclude the presence of prostate cancer, as well as prostatitis and other pelvic pathologies 15 EAU BPH guidelines. Madersbacher S et al. Eur Urol 2004; 46: 547–554

16 Strong relationship between serum PSA and prostate volume enables clinicians to estimate prostate size in BPH patients  Serum PSA thresholds can be used to predict the presence of a prostate >30ml or >40ml with sensitivity between 60-70% and specificity 70%. Along with current prostate size, serum PSA provides prognostic information about:  Prostate growth  Symptoms and bother deterioration  Sexual dysfunction  Flow rate worsening  Risk for AUR and surgery In general higher levels of serum PSA indicate faster and greater risk for progression 16 Roehrborn CG. Int J Impot Res 2008; 20: s19–26

17 Although benign prostatic obstruction is the most frequent cause of LUTS in men, LUTS can also be caused by urinary tract infection or bladder cancer  The absence of haematuria or pyruria on urinalysis helps to rule out these conditions Guidelines recommend urinalysis to aid differential diagnosis 17 EAU BPH guidelines. Madersbacher S et al. Eur Urol 2004; 46: 547–554 AUA Practice Guidelines Committee. J Urol 2003; 170: 530–547

18 Uroflowmetry is a simple non-invasive test that can reveal abnormal voiding. Serial flows (two or more) with a voided volume exceeding 150 ml are recommended to obtain a representative flow test. LUTS in the presence of a normal peak flow rate (Q max = 15ml/s) are more likely to have a non-BPH-related cause, and men with Q max <10 ml/sec are more likely to have urodynamic obstruction Uroflowmetry is recommended by the EAU as part of the initial assessment of a man with LUTS, as well as being required prior to prostatectomy  Uroflowmetry is considered by the AUA to be an option following the initial patient evaluation 18 EAU BPH guidelines. Madersbacher S et al. Eur Urol 2004; 46: 547–554 AUA Practice Guidelines Committee. J Urol 2003; 170: 530–547

19 Measurement of PVR urine is recommended by the EAU guidelines and considered optional by the AUA PVR volume is calculated by measurement of bladder height, width and length obtained by transabdominal ultrasonography  This is a simple, accurate and non-invasive method Large PVR volumes (>200 mL) may indicate bladder dysfunction and predict a less favourable response to BPH treatment EAU BPH guidelines. Madersbacher S et al. Eur Urol 2004; 46: 547–554 19

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21 The aim of therapy is to improve lower urinary tract symptoms (LUTS) and quality of life, and to prevent BPE/BPO- related complications such as urinary retention or upper urinary tract dilatation (EAU) The patient's perception of the severity of the condition, as well as the degree to which it interferes with his lifestyle or causes embarrassment, should be the primary consideration in choosing therapy (AUA) EAU BPH guidelines. Madersbacher S et al. Eur Urol 2004; 46: 547–554 AUA Practice Guidelines Committee. J Urol 2003; 170: 530–547 BPE = Benign prostatic enlargement BPO = Benign prostatic obstruction

22 Initial management of men with LUTS suggestive of BPH can be categorized into:  Watchful waiting  Medical therapy  Surgical management  Non-surgical intervention / Minimally invasive therapy EAU BPH guidelines. Madersbacher S et al. Eur Urol 2004; 46: 547–554 AUA Practice Guidelines Committee. J Urol 2003; 170: 530–547

23 The following are important components of WW: Education Reassurance Periodic monitoring Lifestyle modifications Brown C et al. Curr Opin Urol 2004; 14: 7–12

24 The following medical treatments are recommended for BPH treatment : Alpha blockers (as monotherapy) 5 alpha-reductase inhibitors - 5ARIs (as monotherapy) Combination therapy EAU BPH guidelines. Madersbacher S et al. Eur Urol 2004; 46: 547–554 AUA Practice Guidelines Committee. J Urol 2003; 170: 530–547

25 Dependence on alpha-blocker monotherapy is failing a proportion of men with BPH Need to move away from ‘one-size-fits-all’ medicine to a more personalised approach Need for tailored solutions consistent with treatment guidelines Appropriate treatment needed for men with moderate symptoms onwards, prostate volume ≥30 ml and PSA ≥1.5 ng/ml Emberton M et al. BJU Int 2011 Jan 25. doi: /j X x

26 CombAT study provides insights into treatment of men with moderate symptoms onwards, prostate volume ≥30 ml and PSA ≥1.5 ng/ml Entry criteria for CombAT:  Male aged ≥50 years  Diagnosis of BPH by history and DRE  IPSS ≥12 (moderate-to-severe symptoms)  Prostate volume ≥30 cc by TRUS  Serum PSA 1.5–10.0 ng/ml  Two voids at screening with Qmax >5 and ≤15 ml/sec (moderate-to-severe impairment) and minimum voided volume of ≥125 ml Siami P et al. Contemp Clin Trials 2007;28:770–779

27 What benefit does combination therapy with dutasteride and tamsulosin have on:  Symptoms?  Quality of life?  Risk of long-term complications such as AUR and BPH-related surgery?

28 Baseline Study month Adjusted mean change from baseline in IPSS Roehrborn CG et al. Eur Urol 2010;57:123–131; Barry MJ et al. J Urol 1995;154:1770–74 Tamsulosin (n = 1582)Dutasteride (n = 1592)Combination (n = 1575) p <0.001 combination versus tamsulosin p <0.001 combination versus dutasteride Symptom improvement of at least 3 units is generally considered to be perceptible for the patient and accepted as the minimum threshold of clinical relevance Symptom improvement with combination therapy starts as rapidly as tamsulosin monotherapy

29 Storage symptoms Häkkinen JT et al. Eur Urol 2007;51:473–478 n=1803 to 2046, depending on the symptom Bother index

30 Adjusted mean change from baseline in IPSS storage score *p<0.001 versus combination * * Montorsi F et al. BJU Int 2011 Feb 23; DOI: /j X x

31 Glasser DB et al. Int J Clin Pract 2007;61:1294–1300 Age (years) Prevalence of LUTS subtypes (%) Storage symptoms: sum of scores on IPSS items 2, 4 and 7 was ≥4 and score on item 4 (i.e. urgency) was ≥1 Voiding symptoms: sum of scores on IPSS items 1, 3, 5 and 6 was ≥5 Mixed symptoms: criteria met for both storage and voiding symptoms

32 Adjusted mean change from baseline in IPSS voiding score *p<0.001 versus combination * * Montorsi F et al. BJU Int 2011 Feb 23; DOI: /j X x

33 Over 4 years, combination therapy with dutasteride and tamsulosin provided significantly superior symptom improvement compared with either monotherapy for:  Total symptoms  Storage symptoms  Voiding symptoms Symptom improvement starts as rapidly as tamsulosin monotherapy

34 A disease-specific 4-item instrument that measures the impact of LUTS on  Physical discomfort  Worry about health  Degree of bother  Limitations of daily activities Total scores range from 0 (no impact) to 13 (highest negative impact) Montorsi F et al. Int J Clin Pract 2010;64:1042–1051

35 Adjusted mean change from baseline in BII p≤0.008 combination versus tamsulosin Month p≤0.003 combination versus dutasteride Montorsi F et al. Int J Clin Pract 2010;64:1042–1051 TamsulosinDutasterideCombination Mean baseline BII = 5.3

36 12 questions covering six areas  Control of urinary symptoms  Strength of urinary stream  Two aspects of pain of urination  Effect on usual activities  Overall satisfaction  Whether the respondent would ask their doctor for this medication PPSM total score ranges from 7 (best) to 49 (worst) Question 12: possible responses are yes, no and not sure Montorsi F et al. Int J Clin Pract 2010;64:1042–1051; Black L et al. Health Qual Life Outcomes 2009;7:55

37 Adjusted mean change from baseline in PPSM total score Month p<0.001 combination versus dutasteride Montorsi F et al. Int J Clin Pract 2010;64:1042–1051 p<0.001 combination versus tamsulosin TamsulosinDutasterideCombination Mean baseline PPSM total score = 25

38 Percentage of patients satisfied with treatment p<0.001 combination versus tamsulosin Month p≤0.002 combination versus dutasteride Montorsi F et al. Int J Clin Pract 2010;64:1042–1051 0% TamsulosinDutasterideCombination 80% 74% 69%

39 Montorsi F et al. Int J Clin Pract 2010;64:1042–1051 Percentage of patients responding ‘Yes’ *p<0.01 versus combination * *

40 Combination therapy with dutasteride and tamsulosin provides significantly superior improvements in patient-reported QoL and treatment satisfaction than either monotherapy  Improved overall QoL (IPSS Q8)  Reduced impact of BPH (BII)  Improved treatment satisfaction (PPSM) Superiority of combination therapy versus both monotherapies was sustained out to 4 years

41 Time (months) Percent of patients Combination Dutasteride Tamsulosin Combination Cumulative no. of events No. at risk Dutasteride Cumulative no. of events No. at risk Tamsulosin Cumulative no. of events No. at risk Roehrborn CG et al. Eur Urol 2010;57:123–131 8 months

42 In men with moderate symptoms onwards with prostate volume ≥30 ml and PSA ≥1.5 ng/ml, CombAT shows that over 4 years, combination therapy with dutasteride and tamsulosin  Significantly improves symptoms and QoL versus either monotherapy  Significantly reduces the risk of AUR or BPH-related surgery versus tamsulosin monotherapy

43 43 1 Madersbacher S et al. Eur Urol 2004;46:547–554; 2 Roehrborn CG et al. Eur Urol 2010;57:123–131; 3 Montorsi F et al. Int J Clin Pract 2010; 4 Emberton M et al. Int J Clin Pract 2008; 62: 18–26 Implications of CombAT study: What do these results mean for patients? Men with BPH/LUTS may experience a substantial reduction in their quality of life  In many men, the progressive course of BPH raises the prospect of worsening symptoms, AUR and the need for surgery 4 Major goals of BPH treatment include improvement of symptom scores, lowering risk of disease progression, improving patient-reported quality of life and treatment satisfaction 1 In the CombAT study, combination therapy was associated with:  Improvement of symptoms 2  Reduced risk of BPH clinical progression 2  Reduced risk of AUR or BPH-related surgery 2  Improved patient-reported health outcomes 3

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