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MODULE 2 Module 2: Diagnosis of BPH Luc Valiquette, MD, FRCSC Professor of Surgery, Urology Department of Surgery, Université de Montréal Chief of Urology.

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Presentation on theme: "MODULE 2 Module 2: Diagnosis of BPH Luc Valiquette, MD, FRCSC Professor of Surgery, Urology Department of Surgery, Université de Montréal Chief of Urology."— Presentation transcript:

1 MODULE 2 Module 2: Diagnosis of BPH Luc Valiquette, MD, FRCSC Professor of Surgery, Urology Department of Surgery, Université de Montréal Chief of Urology at Centre Hospitalier de lUniversité de Montréal Montréal, Québec

2 MODULE 2 2/ Learning Objectives After reviewing this module, the learner will be better able to: 1.Perform the differential diagnosis and alarm features used to identify benign prostatic hyperplasia (BPH) 2.Identify which diagnostic assessments are appropriate at the initial evaluation of a typical patient with lower urinary tract symptoms (LUTS) 3.Identify which optional diagnostic assessments are appropriate in selected patients BPH = Benign Prostatic Hyperplasia; LUTS = Lower Urinary Tract Symptoms

3 MODULE 2 3/118 After reviewing this module, the learner will be better able to: 4.Access clinical practice tools to evaluate BPH symptoms 5.Implement CUA diagnostic algorithms in daily clinical practice 6.Understand the appropriate roles of the family physician and recognize the time for specialist referral BPH = Benign Prostatic Hyperplasia; CUA = Canadian Urological Association

4 MODULE 2 4/ Introduction Benign prostatic hyperplasia (BPH) is a naturally progressing, histologic disorder. The most prevalent condition to affect the prostate, it accounts for over 80% of clinical presentations for prostate disease. 1 Most men who visit their physicians for prostate-related problems want to be reassured that they do not have prostate cancer. 1. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p21.

5 MODULE 2 5/118 In the course of a basic evaluation to rule out this disease, BPH may be detected by symptomatology and, if the patient is willing, DRE and serum PSA analysis. Over 40% of men beyond the age of 69 have lower urinary tract symptoms (LUTS) and about half this group has an impaired quality of life 2 The only definitive way to confirm the presence of BPH is by biopsy; however, this procedure is usually regarded as unnecessary and is not part of a routine assessment. 2. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p21. BPH = Benign Prostatic Hyperplasia; DRE=Digital Rectal Examination; PSA=Prostate-Specific Antigen

6 MODULE 2 6/118 This module will review the diagnostic evaluations that are appropriate for the initial assessment of a typical man >50 years of age who presents with LUTS and who is suspected of having BPH. It will focus on evaluations recommended by the Canadian BPH Guidelines. Note that a specialist in Urology should be consulted to assess the man with LUTS under 50 to determine the etiology of the symptoms in order to provide greater assurance that there is no cancer, stricture or other problem. BPH = Benign Prostatic Hyperplasia; LUTS = Lower Urinary Tract Symptoms

7 MODULE 2 7/118 In addition, this module reviews the differential diagnosis of BPH, with particular reference to the differentiation of BPH from prostate cancer, and guidelines for primary-care physicians that suggest when to refer patients with BPH to an urologist for assessment. The diagnostic algorithms and symptom assessment tools may be used in clinical practice to guide the diagnosis of BPH. BPH = Benign Prostatic Hyperplasia

8 MODULE 2 8/ Initial Evaluation This section will explore the diagnostic tests that are appropriate to conduct during the initial visit of a typical patient, i.e., man >50 year of age who complains of LUTS The following diagnostic evaluations are described here: Medical history Lower urinary tract symptoms (LUTS) Physical examination Digital rectal examination (DRE) Diagnostic tests Urinalysis Prostate-specific antigen (PSA) measurement

9 MODULE 2 9/118 Medical History During the initial evaluation of a typical patient >50 years of age who presents with lower urinary tract symptoms (LUTS), a medical history can identify other causes of voiding dysfunction or concomitant medical conditions that may complicate treatment 3 Key elements of the medical history include: 4,5 Focus on urinary tract Identification of LUTS Severity and bother of symptoms Previous surgical procedures History of trauma 3. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p AUA guideline on management of benign prostatic hyperplasia (2003) J. Urol. 2003;170: Nickel JC et al. Canadian guidelines for the management of benign prostatic hyperplasia. Can J Urol. 2005;12:

10 MODULE 2 10/118 Key elements of the medical history contd: 6,7 General health issues Sexual dysfunction Concomitant medical conditions that may lead to bladder dysfunction or excessive urine output Family history of prostate diseases, including BPH and cancer Current medications, including OTC products Fitness for surgery 6. AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170: Nickel JC et al. Canadian guidelines for the management of benign prostatic hyperplasia. Can J Urol. 2005;12: OTC = Over the Counter

11 MODULE 2 11/118 The Identification of LUTS BPH is characterized by a spectrum of obstructive and irritative symptoms, known as LUTS (see Table 2.1) 8 However, other lower urinary tract disorders may produce similar, if not identical, symptoms in aging men 9 LUTS may occur in men with prostate cancer, prostatitis, or many other medical disorders Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physicians guide. Mississauga, ON: Astra Pharma Inc., 1996, p Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p21. BPH = Benign Prostatic Hyperplasia; LUTS = Lower Urinary Tract Symptoms

12 MODULE 2 12/118 A detailed discussion of the differential diagnosis for BPH appears in section 2.6 The major categories are summarized as follows: Dribbling after micturition Concomitant medical conditions Prostate cancer BPH = Benign Prostatic Hyperplasia

13 MODULE 2 13/118 In a significant number of men, non-prostatic causes of LUTS can be excluded on the basis of a medical history, physical examination, and urinalysis 11 The severity of LUTS can be objectively measured by the following clinical assessment tools: 1.International Prostate Symptom Score (IPSS) (or alternatively American Urological Association (AUA) symptom index) 2.Disease-specific Quality of Life (QoL) questionnaire 3.BPH Impact Index 11. Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physicians guide. Mississauga, ON: Astra Pharma Inc., 1996, p19. LUTS = Lower Urinary Tract Symptoms

14 MODULE 2 14/118 Table 2.1: BPH Related LUTS 12,13* Obstructive symptomsIrritative symptoms Hesitancy Weak stream Interruption of urine stream Straining to pass urine Prolonged micturition Feeling of incomplete bladder emptying Acute urinary retention Nocturnal enuresis due to chronic retention Terminal dribbling Nocturia Daytime frequency Urgency Urge incontinence Dysuria 12. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physicians guide. Mississauga, ON: Astra Pharma Inc., 1996, p19. *Note: some experts question the value of categorizing LUTS as obstructive or irritative

15 MODULE 2 15/118 Practice Tip Prostate symptom scores offer a more objective measure of LUTS 14 Practice Tip To avoid interviewer bias, ask patients to self-administer symptom questionnaires. Some clinicians find it efficient to ask patients with LUTS to complete the questionnaires in the waiting room before seeing them, or complete the forms before the next visit. 14. Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physicians guide. Mississauga, ON: Astra Pharma Inc., 1996, p19. LUTS = Lower Urinary Tract Symptoms

16 MODULE 2 16/118 Physical Examination The physical examination must include a digital rectal examination (DRE) and focused neurological assessment. 15 The physical examination is considered mandatory 15,16 The neurological examination should assess: 17,18,19 General mental status Ambulatory status Lower extremity neuromuscular function Bulbocavernosal reflex (if neurologic disease is suspected) Anal sphincter tone Overall motor and sensory function 15. AUA guideline on management of benign prostatic hyperplasia (2003). J.Urol. 2003;170: Nickel JC et al. Canadian guidelines for the management of benign prostatic hyperplasia. Can J Urol. 2005;12: AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. Publication, 2001: Chatelain C et al.Plymouth, UK: Health Publication, 2001: Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25:547.

17 MODULE 2 17/118 Neurological findings may strongly suggest the presence of a neurogenic bladder 20 The absence of neurological findings may help to exclude nervous system disorders, such as Parkinsons disease or a cauda equina lesion, as the underlying cause of LUTS Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25: Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p25. LUTS = Lower Urinary Tract Symptoms

18 MODULE 2 18/118 In addition to the DRE, the focused physical examination should include 22 : 1.Palpation and percussion of abdomen and costovertebral angles to clinically exclude: Hydronephrosis Pyelonephritis Renal mass Bladder dilation 2.Suprapubic palpation and percussion to exclude bladder distension or other mass lesion: 23,24,25 Palpable bladder may indicate significant residual urine and advanced BPH 22. Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25: Chatelain C et al. Plymouth, UK: Health Publication, 2001: Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25: Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physicians guide. Mississauga, ON: Astra Pharma Inc., 1996, p DRE = Digital Rectal Examination; BPH = Benign Prostatic Hyperplasia

19 MODULE 2 19/118 The physical examination should also include: 3.Assessment of general appearance 26 Skin colour and turgor Body weight, posture, build Edema, as a sign of renal insufficiency 4. Genital examination 27 Routine palpation of penis, urethra, testicles and epididymis to rule out unrelated disease processes 26. Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physicians guide. Mississauga, ON: Astra Pharma Inc., 1996, p Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physicians guide. Mississauga, ON: Astra Pharma Inc., 1996, p21-22.

20 MODULE 2 20/118 Practice Tip Urinary tract infections in older men may indicate significant BPH and bladder outlet obstruction 28 Practice Tip Abdominal examination rarely identifies pathology but when abnormalities are discovered it is usually very significant Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25: Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25:547. BPH = Benign Prostatic Hyperplasia

21 MODULE 2 21/118 Digital Rectal Examination (DRE) The digital rectal examination (DRE) is the cornerstone of the physical examination when BPH is suspected 30 The primary purpose of this examination is to rule out prostate cancer, which also produces LUTS 31 The DRE provides useful clinical information for the diagnosis of BPH (see Table 2.2) 32 For the DRE, the patient can lie in a left lateral or knee-elbow position Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170: Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p25. LUTS – Lower Urinary Tract Symptoms; BPH = Benign Prostatic Hyperplasia

22 MODULE 2 22/118 The DRE estimates prostate 34,35 Size Consistency Symmetry Smoothness Tenderness Anatomical limits The DRE can identify abnormalities suggestive of prostate cancer: 36 Nodules Irregularities Firmness 34. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physicians guide. Mississauga, ON: Astra Pharma Inc., 1996, p Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physicians guide. Mississauga, ON: Astra Pharma Inc., 1996, p21-22.

23 MODULE 2 23/118 From the DRE, physicians can estimate the volume of prostates of 50 cm 3 with reasonable accuracy 37 This examination tends to underestimate the volume of larger glands, but if the prostate feels large on DRE, it is usually found to be enlarged by ultrasound or other means of measurement 38, Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physicians guide. Mississauga, ON: Astra Pharma Inc., 1996, p21-22.

24 MODULE 2 24/118 Figure 2.1: Possible Findings on DRE Normal Tenderness Symmetrical Enlargement (BPH) Asymmetry Induration Nodularity DRE = Digital Rectal Exam

25 MODULE 2 25/118 Table 2.2: Clinical Findings of DRE 40,41 Size The normal prostate is slightly smaller than a golf ball (20cm 3 ) In men with BPH: The prostate may rival the size of a tennis ball (>50cm 3 ) The prostate may be mildly, moderately or markedly enlarged. Consistency A prostate with BPH feels firm but smooth, symmetrical, and elastic. A palpable nodule, asymmetrical shape, or diffuse hardening may indicate cancer. Anatomical Limits The prostate should have identifiable limits. In a normal prostate, the median furrow and lateral sulci are preserved. Seminal vesicles should be impalpable; hardening suggests invasion by prostate cancer. 40. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physicians guide. Mississauga, ON: Astra Pharma Inc., 1996, p21-22.

26 MODULE 2 26/118 Diagnostic Tests Urinalysis Urinalysis by dipstick or microscopic examination of urinary sediment is mandatory to screen for: 42,43,44 Hematuria Urinary tract infection (UTI) Proteinuria Pyuria Other pathological findings, e.g., glucose A positive dipstick test is an indication for urine microscopy and culture, and further evaluation and imaging of the renal tract should be considered (see Table 2.3) Nickel JC et al. Canadian guidelines for the management of benign prostatic hyperplasia. Can J Urol. 2005;12: AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170: Chatelain C et al. Plymouth, UK: Health Publication, 2001: Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p25.

27 MODULE 2 27/118 Table 2.3: Findings of Urinalysis 46 Pyuria or bacteriuria Perform midstream urine culture Before any instrumentation of urinary tract, treat UTI. Hematuria Suspect Cancer Refer to urologist 46. Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physicians guide. Mississauga, ON: Astra Pharma Inc., 1996, p24. UTI – Urinary Tract Infection

28 MODULE 2 28/118 Prostate-specific Antigen (PSA) Serum prostate-specific antigen (PSA) is a predictor of the natural history of BPH Serum PSA levels gradually increase over time Men with higher PSA levels have a greater risk of prostate growth in future AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170: BPH = Benign Prostatic Hyperplasia

29 MODULE 2 29/118 Figure 2.2: PSA Predicts Prostate Growth Adapted from Roehrborn CG et al. J Urol 2000;163: PSA = Prostate Specific Antigen Prostate Growth (baseline %) Time (months) PSA tertiles (ng/ml)

30 MODULE 2 30/118 PSA testing, with the DRE, is a relatively sensitive way to rule out prostate cancer in aging men 48 However, the specificity of PSA testing for BPH is a confounding issue. An overlap in diagnostic values exists for men with BPH and those with localized prostate cancer 49 For that reason, PSA levels should not be interpreted alone but together with findings of the DRE Nickel JC et al. Canadian Guidelines for the Management of Benign Prostatic Hyperplasia. Can J Urol. 2005;12: AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170: AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170: PSA = Prostate-Specific Antigen; DRE = Digital Rectal Examination

31 MODULE 2 31/118 Guidelines for Early Detection of Prostate Cancer DRE and PSA Tests Increase the early detection of prostate cancer Are indicated when prostate cancer is suspected Are indicated in the management of prostate cancer May help decide on treatment CUA 1996; CPSM 1995; CMQ 1998; DRE = Digital Rectal Examination; PSA = Prostate-Specific Antigen

32 MODULE 2 32/118 Other factors can elevate or suppress serum PSA levels, leading to false values, including: 51 Prostatitis Sexual activity Infection Medications Patients should be informed of the risks and benefits of PSA measurement American Urology Association. Oncology. 2000;14: AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170: PSA = Prostate-Specific Antigen

33 MODULE 2 33/118 PSA Testing – Yes or No? ProsCons Increases cancer detection rate Substantial false positive rate May detect cancers earlier False positives trigger additional tests No patient morbidity False negative rate Estimate for prostate size in the absence of cancer Not proven to prolong survival Predicts BPH progression P, et al. Int J Pharm 2002; 238(1-2):1-9;Gander L (HSURC) 2000;www.hsurc.sk.ca; AUA. Oncology 2000;14:267-86;CMQ 1998;www.cmq.org/Prostateang.pdf;CPSM 1995.ww.umanitoba.ca/academic/colleges/cps/guidelines_and_statements/3.17.html

34 MODULE 2 34/118 When to Test Serum PSA The PSA test is recommended for: 53 Patients who have at least a 10 year life expectancy and for whom knowledge of the presence of prostate cancer would change management Men for whom PSA measurement may change the management of their voiding symptoms (by the estimation of prostate volume) 53. Nickel JC et al. Canadian Guidelines for the Management of Benign Prostatic Hyperplasia. Can J Urol. 2005;12: PSA = Prostate-Specific Antigen

35 MODULE 2 35/118 Figure 2.3: Prediction of Average Prostate Volume Based Upon Serum PSA and Age Serum PSA, ng/ml Prostate Volume (cc) AGE (years) Adapted from Roehrborn CG et al. Urology 1999;53: PSA = Prostate-Specific Antigen

36 MODULE 2 36/118 PSA and Progression Serum PSA measurement can be used as a biomarker for BPH disease progression Men with symptoms and a PSA of 1.4 ng/mL are more likely to have a larger prostate (> 30 cc) with progressive BPH, deteriorating symptoms and urinary flow rate over time, and a higher risk of acute urinary retention and future surgery 54 Men with symptoms and a serum PSA of <1.4 ng/mL are more likely to have a smaller prostate (<30 cc) and a lower likelihood of disease progression 55, Roehrborn CG et al for the PLESS group. Urology. 1999;54: Roehrborn CG et al for the PLESS group. Urology. 1999;54: Bartsch G et al. BJU International. 2004;93(S1):27-9. PSA = Prostate-Specific Antigen; BPH = Benign Prostatic Hyperplasia

37 MODULE 2 37/118 Figure 2.4: PSA and Symptoms *,** *Symptom scores (mean ± 95% confidence interval) stratified by baseline serum PSA. **Data from the 4-year, randomized, placebo-controlled PLESS study in which a total of 3040 men with BPH were enrolled and assigned to once-daily finasteride 5mg or placebo. Symptoms and flow rate were assessed every 4 months, and data were analyzed by dividing the placebo-treated patients into 3 groups by baseline PSA tertiles (0 to 1.3, 1.4 to 3.2, and 3.3 ng/mL or greater). Quasi-AUA = the symptom score based on an adaptation of the American Urological Association symptom scale; BPH= benign prostatic hyperplasia; PLESS = Proscar Long-Term Efficacy and Safety Study; PSA = prostate-specific antigen; SE=standard error. Adpated from Roehrborn CG et al. Urology 1999;54(4): PSA 3.3 – 12 ng/mL PSA 1.4 – 3.2 ng/mL PSA 0 – 1.3 ng/mL Quasi-AUA symptom score mean change ± SE Years on Study

38 MODULE 2 38/118 Figure 2.5: Bother and PSA Adapted from Bruskewitz R et al. Urology 1999;54: ; PSA = Prostate-Specific Antigen PSA 0 – 1.3 PSA 1.4 – 3.2 PSA PSA tertiles (ng/mL) Year of follow up Mean (SE) change in bother score

39 MODULE 2 39/118 Figure 2.6: Peak Flow Rates and PSA Adapted from Roehrborn CG et al. Urology 1999;54: ; PSA = Prostate-Specific Antigen PSA tertiles (ng/ml) PSA 0–1.2 PSA 1.3–3.2 PSA 3.2–10 Months

40 MODULE 2 40/118 Figure 2.7: Incidence of Surgery and AUR over 4 years by PSA Tertiles 6.2% 9.9% 14.6% SurgeryAUR 2.9% 5.8% 12.6% Baseline PSA tertiles PSA 0–1.2 ng/ml PSA 1.3–3.2 ng/ml PSA >3.2 ng/ml (Placebo-treated BPH) Incidence (%) Adapted from Roerhborn CG. AUA 2005.

41 MODULE 2 41/118 Figure 2.8: MTOPS Subanalysis PSA and Risk of BPH Progression Rate per 100 PYR p = p = p = <1.6 ng/ml p = McConnell JD et al. J Urol. 2003;169(suppl): ng/ml Overall Progression Symptom Progression AURInv. Therapy

42 MODULE 2 42/118 Practice Tip The risk of BPH progression is higher in men with a PSA >1.4 ng/mL 59 Practice Tip PSA alone is insufficient to detect localized prostate cancer Kirby RS. UK;Prostate Research Campaign UK, 2000, pp Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25:548. BPH = Benign Prostatic Hyperplasia; PSA = Prostate-Specific Antigen

43 MODULE 2 43/118 Figure 2.9: Prostate-specific Antigen (PSA) and How it Gets into the Blood Stream Adapted from Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p28.

44 MODULE 2 44/118 More Information About Serum PSA A 4-year, multicentre study of 164 men with BPH in the placebo group of the Proscar Long-term Efficacy and Safety Study (PLESS) established that serum PSA is a stronger predictor of prostate growth than age or baseline prostate volume 62 (Refer to Figure 2.2) 62. Roehrborn CG et al for the PLESS group. J Urol. 2000;163:13. BPH = Benign Prostatic Hyperplasia; PSA = Prostate-Specific Antigen

45 MODULE 2 45/118 These men had an overall growth rate in prostate volume of 1.8cc per year. Prostate growth increased steadily by 5.2% in the first year, 9.0% in the second year, 11.8% in the third year, and 14.1% in the fourth year. In another analysis of the PLESS study, a strong association between prostate volume or PSA and the risk of acute urinary retention and a need for BPH-related surgery was demonstrated. Serum PSA measurement was established as an important predictor of BPH-related outcomes. BPH = Benign Prostatic Hyperplasia; PSA = Prostate-Specific Antigen

46 MODULE 2 46/118 Earlier analysis of PLESS placebo-group data showed that baseline PSA values and prostate volume are good predictors of long-term changes in symptoms and flow rate changes in men with BPH 63 Men with a PSA of 1.4 ng/mL and to a larger extent those with a PSA of 3.2 ng/mL were more likely to have a larger prostate with progressive BPH, a higher risk of acute urinary retention and future surgery, and deteriorating symptoms and urinary flow rate over time. 63. Roehrborn CG et al for the PLESS group. Urology. 1999;54: BPH = Benign Prostatic Hyperplasia; PSA = Prostate-Specific Antigen

47 MODULE 2 47/118 Age-specific serum PSA reference ranges were first established in 1993, based on a 2-year study of a community-based population of 2119 healthy white men in Olmstead County, Minnesota, USA 64 This study determined that serum PSA concentration is directly correlated with patient age and prostate volume. 64. Oesterling JE et al. JAMA. 1993;270: PSA = Prostate-Specific Antigen

48 MODULE 2 48/118 Subsequent studies found that PSA levels vary in different racial groups, with black men having higher PSA levels than whites Morgan TO et al. N Engl J Med. 1996;335: PSA = Prostate-Specific Antigen

49 MODULE 2 49/118 Table 2.4: Relative Risk of Prostate Enlargement by PSA Level *Estimated by hazard function The Wald chi-square statistic was used in the model to calculate p values for comparisons between a PSA quartile and reference (lowest) quartile. Wright JE et al. J Urol. 2002;167:2485. ; PSA = Prostate-Specific Antigen

50 MODULE 2 50/118 An analysis of 4627 patients from BPH trials and a safety study confirmed that prostate volume is strongly related to serum PSA in men with BPH and no evidence of prostate cancer and that this relationship depends on age Roehrborn CG et al. Urology. 1999;53: BPH = Benign Prostatic Hyperplasia PSA = Prostate-Specific Antigen

51 MODULE 2 51/118 Table 2.5: Age-Specific Ranges* for Serum PSA Levels in Healthy Men – – – –0.08 PSA density (ng/mL per mL) –51 Prostate volume (mL) 0.0–6.50.0–4.50.0–3.50.0–2.5 Age (years) PSA (ng/mL) Oesterling JE et al. JAMA. 1993;270: ; PSA = Prostate-Specific Antigen *Upper limit of normal for PSA and PSA density was defined as the 95th percentile for the midpoint of age range from regression analysis; for prostate volume, 97.5th percentile was used. Lower limits for PSA and PSA density were set at 0.0; for prostate volume, at 2.5th percentile.

52 MODULE 2 52/118 Table 2.6: Age-Specific Reference Ranges for Serum PSA Levels in Healthy Men of Different Race 69 Age (years)WhiteBlack –2.50.0– –3.50.0– –3.50.0– –3.50.0– Wright JE et al. J Urol. 2002;167: Morgan TO et al.. N Engl J Med. 1996;335:309. PSA = Prostate-Specific Antigen Note: This is based on the 5th percentile of the distribution of PSA levels 70

53 MODULE 2 53/118 Table 2.7: Age-Specific Criteria for Detection of Prostate Volume 40 cc 71* Age (years)Serum PSA level (ng/mL) 50-59> > > Roehrborn CG et al. Urology. 1999;53: Adapted from Roehrborn CG et al. Urology. 1999;53:581. PSA = Prostate-Specific Antigen *These criteria have a specificity of 70% and sensitivity of 65–70%.

54 MODULE 2 54/118 Use of PSA as a Screening Tool The 2005 Canadian Guidelines for the Management of BPH contain no recommendations with regard to the screening of men for BPH by serum PSA analysis 72 Serum PSA levels are not specific enough to distinguish between BPH and localized prostate cancer 73 The value of PSA measurement for BPH screening has yet to be determined, although its role in the early detection of prostate cancer may be soon elucidated by ongoing randomized trials in the USA and Europe Nickel JC et al. Canadian guidelines for the management of benign prostatic hyperplasia. Can J Urol. 2005;12: Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25: Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p29. BPH = Benign-Prostatic Hyperplasia; PSA = Prostate-Specific Antigen

55 MODULE 2 55/ Optional Diagnostic Tests The following diagnostic evaluations are described here: Urine cytology Abdominal ultrasound Transrectal ultrasound Serum creatinine Intravenous urography (IVU) Cystoscopy Urine flow study (uroflowmetry) Urodynamic tests (Pressure-Flow Studies) Post-void residual urine (PVR) measurement

56 MODULE 2 56/118 Urine Cytology Urine cytology may be considered in men with predominantly irritative symptoms, especially men with a history of smoking or other risk factors, to rule out the presence of bladder cancer or bladder carcinoma in situ AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170:532.

57 MODULE 2 57/118 Abdominal Ultrasound Easy-to-use, non-invasive, and reproducible procedure Abdominal Ultrasound is slightly less precise at determining prostate size, shape, and volume than Transrectal Ultrasound of the Prostate (TRUS) 76 This technology is best used to assess post-void residual (PVR) urine non-invasively (See post-void residual urine) Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25: Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p31-3

58 MODULE 2 58/118 Abdominal ultrasound with a machine that generates real-time, B- mode images can simultaneously assess residual urine, prostate size and shape, prostate-bladder configuration, and protrusion in the bladder 78 This test is not indicated in initial patient evaluations, unless the patient has renal failure. 78. Chatelain C et al. Plymouth, UK: Health Publication, 2001:524

59 MODULE 2 59/118 It is an optional diagnostic test for the evaluation of patients who choose certain medical therapies and minimally invasive or invasive surgery, particularly the following techniques, in which patient selection is influenced by anatomical features of the prostate 79,80 Hormonal therapy Thermotherapy Transurethral Needle Ablation (TUNA) Transurethral Incision of the Prostate (TUIP) Transurethral Resection of the Prostate (TURP) Stents 79. Chatelain C et al. Plymouth, UK: Health Publication, 2001: AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170:534.

60 MODULE 2 60/118 Figure 2.10: Abdominal Ultrasound Scan Showing Post-void Residual Urine and an Enlarged Benign Prostate Bulging into the Bladder Source: Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p31.

61 MODULE 2 61/118 Transrectal Ultrasound (TRUS) Although prostate volume correlates with LUTS in large populations of patients, individual findings may differ 81 TRUS is an easy to use, non-invasive, and easily reproducible technique that assesses prostate size, shape, and volume 82 The determination of prostate volume has prognostic value for the natural history of BPH and patients response to 5α reductase inhibitors Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25: Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25: AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170:534. LUTS = Lower Urinary Tract Symptoms; BPH = Benign Prostatic Hyperplasia

62 MODULE 2 62/118 TRUS determines prostate volume far more precisely than DRE or serum PSA and somewhat better than abdominal ultrasound, but it is not recommended in routine practice 84 Combined with biopsy, it is the method of choice to rule out prostate cancer and other differential diagnoses 85,86 TRUS is not a standard diagnostic procedure for all patients over 50 years of age with bladder outflow obstruction (BOO) due to BPH. 87 This evaluation is not routinely necessary before watchful waiting or medical therapy Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25: AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170: Chatelain C et al. Plymouth, UK: Health Publication, 2001: Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25: DRE = Digital Rectal Examination; PSA = Prostate-Specific Antigen; BPH = Benign Prostatic Hyperplasia

63 MODULE 2 63/118 TRUS may be an appropriate optional test when certain medical therapies and minimally invasive or surgical interventions are chosen, as prostate size and shape as well as the presence of anatomical features, such as intravesical lobes, are important factors in patient selection for: 89,90 Hormonal therapy Thermotherapy Transurethral Needle Ablation (TUNA) Transurethral Incision of the Prostate (TUIP) Transurethral Resection of the Prostate (TURP) Stents 89. AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170: Chatelain C et al. Plymouth, UK: Health Publication, 2001:524.

64 MODULE 2 64/118 Figure 2.11: Transrectal Ultrasound-guided Biopsy of the Prostate with an Automated Biopsy Device Adapted from Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p32.

65 MODULE 2 65/118 Serum Creatinine In the Canadian guidelines serum creatinine determination is optional, based on the patients clinical situation, e.g., severe symptoms, complications, AUR, scheduled for surgery, etc 91 In the American Urology Association (AUA) guidelines, serum creatinine measurement is no longer recommended on initial evaluation of typical patients 92 The AUA decision was based on a review of several large BPH trials with more than 10,000 patient-years of follow-up Nickel JC et al. Canadian Guidelines for the Management of Benign Prostatic Hyperplasia. Can J Urol. 2005;12: AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170:532. BPH = Benign Prostatic Hyperplasia

66 MODULE 2 66/118 If the patients renal history, physical examination, or urinalysis suggests renal disease or urinary retention, serum creatinine may be indicated prior to renal imaging studies that use intravenous contrast

67 MODULE 2 67/118 Intravenous Urography or Abdominal Ultrasound of the Upper Urinary Tract Intravenous urography (IVU) and abdominal ultrasound of the upper urinary tract are used to evaluate dilation of the upper urinary tract. It provides some information about prostate volume, bladder condition, and differential diagnoses, such as tumours and stones 93 Men with LUTS do not have a higher prevalence of these conditions than the normal population 94 Ultrasound is better than IVU at detecting hydronephrosis, renal stones, and tumours. 93. Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25: Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25:550. LUTS = Lower Urinary Tract Symptoms

68 MODULE 2 68/118 IVU should not be performed in patients with borderline high serum creatinine because of the higher risk of exacerbating renal failure About 0.1% of patients have severe side effects from IVU There is solid evidence against the routine use of this procedure in men with BPH Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25:550. BPH = Benign-Prostatic Hyperplasia

69 MODULE 2 69/118 Imaging of the upper urinary tract is optional for men with LUTS and may be performed by abdominal ultrasound or by IVU in selected cases. Upper urinary tract imaging is recommended in men with LUTS who present with the following clinical features: 96 History of recurrent upper UTI Hematuria History of urinary stones Renal insufficiency 96. Chatelain C et al. Plymouth, UK: Health Publication, 2001:525. LUTS = Lower Urinary Tract Symptoms

70 MODULE 2 70/118 Cystoscopy Also known as cystourethroscopy, this procedure may obtain information about prostate size and Bladder Outlet Obstruction (BOO)-related findings, such as: Bladder stones Trabeculations Diverticula of the bladder It may reveal serious differential diagnoses, including bladder cancer and urethral strictures Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25:550.

71 MODULE 2 71/118 The value of cytoscopy has not been documented in men with BPH 98 Uncommon complications after cystoscopy include infection, bleeding, and acute urinary retention. This procedure is indicated only in men with suspected alternative pathology and optional in men with moderate to severe LUTS with planned invasive therapy Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25: Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25:550. BPH = Benign Prostatic Hyperplasia; LUTS = Lower Urinary Tract Symptoms

72 MODULE 2 72/118 Urine Flow Study (Uroflowmetry) The electronic measurement of urine flow (uroflowmetry) is helpful in identifying men with LUTS who are unlikely to benefit from surgery Men with significant LUTS and a normal peak flow rate (Qmax) are more likely to have an overactive bladder than BPH Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p LUTS = Lower Urinary Tract Symptomsl BPH = Benign Prostatic Hyperplasia

73 MODULE 2 73/118 Uroflowmetry measures the peak flow rate (Qmax), which decreases with age, ranging from >25 mL/s in young men to <10 mL/s in 80-year- old men 101 There is no established threshold or cut-point for abnormal peak flow rate, as well-designed outcome studies are lacking, but a Qmax of <15 mL/s suggests BOO 102 The specificity and sensitivity of uroflowmetry is low Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25: Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25:548. BOO = Bladder Outlet Obstruction

74 MODULE 2 74/118 This test poorly predicts the failure of watchful waiting and a patients response to medical therapy 104 The Qmax is a weak predictor of surgical outcome and, in patients with a Qmax of <10 mL/s, uroflowmetry cannot differentiate benign prostatic obstruction (BPO) from decreased bladder contractility. About half of men with BPH have >2 standard deviations of variation in Qmax on two consecutive tests. Due to void-to-void variability in peak flow rates, at least two uroflows of >150 mL of voided urine should be collected 105,106, AUA guideline on management of benign prostatic hyperplasia (2003). Urol. 2003;170: AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170: Chatelain C et al. Plymouth, UK: Health Publication, 2001: Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25:548. BPH = Benign Prostatic Hyperplasia

75 MODULE 2 75/118 Practice Tip The patient should obtain the Qmax from a normal voiding position, in private, when he feels the urge to void 108 Uroflow is not necessary for treatment decisions in the majority of BPH patients Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25:548.

76 MODULE 2 76/118 Urodynamics (Pressure-Flow Study) Although invasive, the pressure-flow urodynamic study is the only test with the potential to distinguish BPH-related outflow obstruction (BOO) from impaired detrusor contractility, particularly in men with a low urinary flow rate 109 Routine urodynamic testing is not recommended in patients over 50 years of age with BPH and is considered as optional in men prior to surgery or when a precise diagnosis of BOO is important 110, 111 The 5th International Consultation on BPH recommends pressure- flow studies in all men with a Qmax >10mL/s, when surgery is being considered Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p Chatelain C et al. Plymouth, UK: Health Publication, 2001: AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170:534. BPH = Benign Prostatic Hyperplasia

77 MODULE 2 77/118 Urodynamics offer the greatest benefits in men with a concomitant neurologic disease that affects bladder function, e.g., stroke, Parkinsons disease, diabetic neuropathy, or a history of prior surgery for BPH 112 Urodynamic studies are not useful to predict the outcome of medical therapy 113 A small catheter is inserted urethrally or suprapubically to measure bladder pressure. This procedure may cause some discomfort 114 The most important parameter of urodynamic tests is detrusor pressure (pdet) at the time of peak urinary flow (Qmax). 112 AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170: Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25: Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p31-2.

78 MODULE 2 78/118 Post-Void Residual Urine (PVR) For patients in whom the clinical picture is unclear, the assessment of post-void residual urine (PVR) may be helpful 115 This optional test cannot confirm or exclude a diagnosis of BPH 116 There is no evidence to suggest that it has value for predicting the outcome of treatment in patients with PVR of <300 mL Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physicians guide. Mississauga, ON: Astra Pharma Inc., 1996, p Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p Chatelain C et al. Plymouth, UK: Health Publication, 2001:524.

79 MODULE 2 79/118 Table 2.8: PVRs Measured within Minutes of Voiding <50mlNormal mlAcceptable depending on clinical situation >200ml Usually abnormal and should be referred to a urologist for an evaluation AHCPR guidelines 1994 PVR = post-void residual urine

80 MODULE 2 80/118 During the physical examination, the physician can check for bladder distention (significant PVR) by suprapubic percussion and palpation 118 Abdominal ultrasound or, less commonly, catheterization is used to measure PVR accurately. As there is considerable void-to-void variation in PVR, treatment decisions are not based on a single assessment 119 If the first PVR urine volume is significant or suggest a change in treatment plan, the assessment should be repeated Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physicians guide. Mississauga, ON: Astra Pharma Inc., 1996, p Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p Chatelain C et al. Plymouth, UK: Health Publication, 2001:524. PVR = post-void residual urine

81 MODULE 2 81/118 Repeat PVR assessment over time may detect worsening BPO; therefore, PVR may be a useful safety measure for monitoring the progress of patients who choose watchful waiting 121,122 PVR values above 200–300 mL may indicate a higher risk of acute urinary retention (AUR) and a greater need for invasive surgery Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physicians guide. Mississauga, ON: Astra Pharma Inc., 1996, p Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p PVR = post-void residual urine

82 MODULE 2 82/118 Large PVR volumes may be associated with bladder dysfunction and neurological disease, and a slightly less favorable treatment response 124 Patients with a consistently high PVR of >300 mL should be referred to an urologist for further evaluation, which may eventually lead to transurethral surgery Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25: Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p PVR = post-void residual urine

83 MODULE 2 83/118 Practice Tip There is no demonstrable correlation between PVR and UTIs in men with BPH 126 Practice Tip Many patients maintain a fairly large PVR without evidence of UTI, renal insufficiency, or bothersome symptoms Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25: AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170:533. UTI = Urinary Tract Infection; PVR = post-void residual urine; BPH = Benign Prostatic Hyperplasia

84 MODULE 2 84/ Symptom Assessment Tools This section includes three practical tools for symptom assessment in daily clinical practice. They are: IPSS for BPH and the disease-specific quality of life (QoL) questionnaire Voiding diary Sexual function questionnaire IPSS = International Prostate Symptom Score; BPH = Benign Prostatic Hyperplasia

85 MODULE 2 85/118 IPSS and AUA Symptom Score and Disease-Specific QoL Questionnaire The IPSS and AUA symptom index use the same seven questions, which are presented here. The IPSS also uses a disease-specific quality-of-life (QoL) question AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170: IPSS = International Prostate Symptom Score; AUA = American Urological Association

86 MODULE 2 86/118 Questionnaire: International Prostate Symptom Score (IPSS) Patient Name DOB: ID: Date Of Assessment Initial Assessment( ) Monitor During Therapy ( ) After Therapy ( ) / Surgery ( ) Over the past month, how often have you had to urinate again less than two hours after you finished urinating? Over the past month, how often have you had a sensation of not emptying your bladder completely after you finished urinating? Total Almost always More than half the time About half the time Less than half the time Less than 1 time in 5 Not at all International Prostate Symptom Score

87 MODULE 2 87/ Over the past month, how often have you found you stopped and started again several times when you urinated? Over the past month, how often have you found it difficult to postpone urinating? Over the past month, how often have you had a weak urinary stream? Over the past month, how often have you had to push or strain to begin urinating? None1 time2 times3 times4 times 5 or more times 7. 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? Total Almost always More than half the time About half the time Less than half the time Less than 1 time in 5 Not at all Total I-PSS Score S = Cockett ATK et al (eds.). Consensus recommendations. In: The International Consultation on BPH. Paris: SCI IPSS Contd

88 MODULE 2 88/ If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? TerribleUnhappy Mostly dissatisfied Mixed about equally satisfied and dissatisfied Mostly satisfiedPleasedDelighted Quality of Life due to Urinary Symptoms Questionnaire: Quality of Life (QoL) Cockett ATK et al (eds.). Consensus recommendations. In: The International Consultation on BPH. Paris: SCI

89 MODULE 2 89/118 Voiding Diary Voiding diaries are particularly useful when nocturia is the predominant symptom of LUTS 131,132 In the voiding diary, the patient tracks the frequency and volume of fluid intake and urination. Voiding diaries, once completed for several 24-hour periods, can help to identify patients with nocturnal polyuria, excessive fluid intake, or symptoms suggestive of bladder overactivity (OAB). All conditions are common in aging men 133, Chatelain C et al. Plymouth, UK: Health Publication, 2001: AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170: Chatelain C et al. Plymouth, UK: Health Publication, 2001: AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170:532. LUTS = Lower Urinary Tract Symptoms

90 MODULE 2 90/118 Adapted from Chatelain C et al. Plymouth, UK: Health Publication, 2001:523 Sample Voiding Diary

91 MODULE 2 91/118 Sexual Function Questionnaire LUTS are an independent risk factor for sexual dysfunction, which may impair quality of life in men with BPH In addition, medical therapy for BPH may impact sexual function. Since sexual dysfunction is treatable, men with BPH should be asked specifically about this problem Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p21. LUTS = Lower Urinary Tract Symptoms; BPH = Benign Prostatic Hyperplasia

92 MODULE 2 92/118 Figure 2.12: Erectile Dysfunction (ED) is Associated with LUTS and BPH ED (N=853) No ED (N=3581) Diabetes 20.2%3.2% Hypertension 32.0%13.6% Pelvic Surgery 18.8%2.4% LUTS 72.2%37.3% Smokers 29.6%34.6% Regular Alcohol 37.5%42.4% Braun M et al. Int J Impot Res 2000; 12: ; LUTS = Lower Urinary Tract Symptoms; BPH = Benign Prostatic Hyperplasia

93 MODULE 2 93/118 Figure 2.13: Impact of Medical Treatment for BPH on Sexual Function % Patients Terazosin Alfuzosin Doxazosin Finasteride Tamsulosin Treatment Ejaculation Disorders Erectile Dysfunction Altwein J. XVIIth EAU Congress, Bimingham UK, Feb 2002, Sanofi-Synthelabo satellite.

94 MODULE 2 94/118 Sample Questionnaire: INTERNATIONAL INDEX OF ERECTILE FUNCTION (IIEF) Patient Questionnaire These questions ask about the effects that your erection problems have had on your sex life over the last four weeks. Please try to answer the questions as honestly and as clearly as possible. In answering the questions, the following definitions apply: sexual activity includes intercourse, caressing, foreplay & masturbation sexual intercourse is defined as sexual penetration of your partner sexual stimulation includes situation such as foreplay, erotic pictures etc. ejaculation is the ejection of semen from the penis (or the feeling of this) orgasm is the fulfilment or climax following sexual stimulation or intercourse 1. How often were you able to get an erection during sexual activity? 2. When you had erections with sexual stimulation, how often were your erections hard enough for penetration? Almost always - always Most times (more than half the time) Sometimes (about half the time) A few times (less than half the time) Almost never - never No sexual activity Almost always - always Most times (more than half the time) Sometimes (about half the time) A few times (less than half the time) Almost never - never No sexual activity

95 MODULE 2 95/ When you attempted sexual intercourse, how often were you able to penetrate (enter) your partner? 4. During sexual intercourse, how often were you able to maintain your erection after you had penetrated (entered) your partner? Almost always - always Most times (more than half the time) Sometimes (about half the time) A few times (less than half the time) Almost never - never No sexual activity Almost always - always Most times (more than half the time) Sometimes (about half the time) A few times (less than half the time) Almost never - never No sexual activity 5. During sexual intercourse, how difficult was it to maintain your erection to completion of intercourse? 6. How many times have you attempted sexual intercourse? Almost always - always Most times (more than half the time) Sometimes (about half the time) A few times (less than half the time) Almost never - never No sexual activity Almost always - always Most times (more than half the time) Sometimes (about half the time) A few times (less than half the time) Almost never - never No sexual activity IIEF Contd

96 MODULE 2 96/ How much have you enjoyed sexual intercourse? 8. When you had sexual stimulation or intercourse, how often did you ejaculate? 9. When you had sexual stimulation or intercourse, how often did you have the feeling of orgasm or climax? Almost always - always Most times (more than half the time) Sometimes (about half the time) A few times (less than half the time) Almost never - never No sexual activity Almost always - always Most times (more than half the time) Sometimes (about half the time) A few times (less than half the time) Almost never - never No sexual activity Almost always - always Most times (more than half the time) Sometimes (about half the time) A few times (less than half the time) Almost never - never No sexual activity 10. How often have you felt sexual desire? Almost always - always Most times (more than half the time) Sometimes (about half the time) A few times (less than half the time) Almost never - never No sexual activity IIEF Contd

97 MODULE 2 97/118Adapted from Rosen RC et al. Urology Jun;49(6): How would you rate your level of sexual desire? 12. How satisfied have you been with your overall sex life? Very highHighModerateLowVery low – none at all Very satisfiedModerately satisfied About equally satisfied and dissatisfied Moderately dissatisfied Very dissatisfied 13. How satisfied have you been with your sexual relationship with your partner? 14. How would you rate your confidence that you could get and keep an erection? Very satisfiedModerately satisfied About equally satisfied and dissatisfied Moderately dissatisfied Very dissatisfied Very highHighModerateLowVery low – none at all IIEF Contd

98 MODULE 2 98/ Differential Diagnosis of BPH Dribbling after Micturition Dribbling after micturition may indicate urine pooling in the bulbar urethra rather than benign prostatic obstruction (BPO) 137 This condition is frequent and can be troublesome. The treatment is compression of the perineal area and milking of the bulbar urethra Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p21.

99 MODULE 2 99/118 Concomitant Medical Conditions The following medical conditions must be excluded before the patient can be diagnosed with BPH: Neurological conditions 2.Inflammatory disorders 3.Neoplastic disorders 4.Causes of polyuria 5.Other causes of obstruction 138. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p21.

100 MODULE 2 100/118 1.Neurological Conditions 139 Parkinsons disease Cerebrovascular trauma Shy-Drager syndrome Multiple sclerosis Cerebral atrophy 139. Kirby RS. Abingdon, UK: Prostate Research Campaign UK, 2000, p8, Kirby RS. Abingdon, UK: Prostate Research Campaign UK, 2000, p8, Inflammatory Disorders 140 Urinary tract infection Bladder stones Interstitial cystitis Tuberculous cystitis

101 MODULE 2 101/118 3.Neoplastic Disorders 141 Prostate cancer Bladder cancer 141. Kirby RS. Abingdon, UK: Prostate Research Campaign UK, 2000, p8, Kirby RS. Abingdon, UK: Prostate Research Campaign UK, 2000, p8, Causes of Polyuria 142 Diabetes Congestive heart failure Excessive fluid intake

102 MODULE 2 102/118 5.Other Causes of Obstruction Bladder neck dyssynergia External sphincter dyssynergia Urethral stricture Severe phimosis

103 MODULE 2 103/118 Figure 2.14: Differential Diagnosis Extrinsic Pelvic Mass Prostate Cancer Urethral Stricture Bladder Dysfunction (Diabetes) BPH Cystitis Cystolithiasis Hypertrophy or Stenosis of Bladder Neck Medications Anticholinergics Antidepressants Decongestants Vesicosphincter dyssynergia Bladder Cancer Adapted from Ouslander JG. Am J Med Sci 1997;314(4):214-8; Kasraeian A. Stenosis of urinary meatus Phimosis Urethritis Urethral carcinoma

104 MODULE 2 104/118 Prostate Cancer The differentiation of BPH and prostate cancer is a critical issue for primary-care physicians and urologists The DRE gives the first clues that differentiate BPH from prostate cancer 143 During the early stages of cancer, PSA leaks from cancerous prostate tissue into the blood, where elevated levels can be detected Kirby RS. The prostate: small gland, big problem. Abingdon, UK: Prostate Research Campaign UK, 2000, p8, BPH = Benign Prostatic Hyperplasia; DRE = Digital Rectal Examination; PSA = Prostate-Specific Antigen

105 MODULE 2 105/118 The overlap in PSA levels for men with BPH and early prostate cancer can lead to diagnostic confusion. A serum PSA >4 ng/mL has traditionally been used as the threshold for consideration of prostate biopsy, but the National Comprehensive Cancer Network (NCCN) has recommended that physicians should consider biopsies in men with a PSA >2.5 ng/mL National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version , pPROSD-1,2,4,5; MS-4-6. PSA = Prostate-Specific Antigen; BPH = Benign Prostatic Hyperplasia

106 MODULE 2 106/118 PSA Velocity 145 For men with a PSA <10 ng/mL, data suggest that PSA velocity of 0.75 ng/mL per year is suspicious for prostate cancer. The NCCN recommends three measurements over at least 18 months to determine PSA velocity National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version , pPROSD-1,2,4,5; MS National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version , pPROSD-1,2,4,5; MS-4-6. PSA = Prostate-Specific Antigen

107 MODULE 2 107/118 Free PSA 147 The FDA has recently approved the use of free PSA (fPSA) in men with total serum PSA of 4–10 ng/mL for the detection of prostate cancer. This test measures the percentage of unbound (free) serum PSA. Numerous studies have shown that the percentage of fPSA is significantly lower in men with prostate cancer National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version , pPROSD-1,2,4,5; MS-4-6. FDA = U.S. Food and Drug Administration PSA = Prostate-Specific Antigen

108 MODULE 2 108/118 An fPSA cut-off of 25% has been shown to detect 95% of prostate cancer, while reducing unnecessary biopsies by 20%. The use of fPSA has outperformed PSA density in early detection studies. The NCCN uses the following fPSA cut-offs: > 25%: no biopsy 10–25%: discuss risks/benefits of biopsy < 10%: biopsy Note: these are not defined percentages and various laboratories have different values.

109 MODULE 2 109/118 Complexed PSA 148 This test measures the form of PSA that is complexed with α 1 - antichymotrypsin Complexed PSA (cPSA) has a higher specificity than total PSA (tPSA) measurement and only requires a single laboratory measurement, as opposed to fPSA, which requires two measurements 148. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version , pPROSD-1,2,4,5; MS-4-6.

110 MODULE 2 110/118 Practice Tips Elevated PSA and abnormal DRE suggest that the LUTS may be secondary to prostate cancer. PSA = Prostate-Specific Antigen; DRE = Digital Rectal Examination; LUTS = Lower Urinary Tract Symptoms

111 MODULE 2 111/118 Table 2.9 : PSA Findings PSA Level (ng/mL)Interpretation <4 Normal, unless rising by >25% (0.75ng/mL) per year % risk of cancer >10>50% risk of cancer (indication for biopsy) Rise of >0.75ng/mL per yearRefer to urologist for urgent assessment Adapted from Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p27. PSA = Prostate-Specific Antigen

112 MODULE 2 112/ Indications for Referral to Urologist These findings indicate the need for primary-care physicians to refer the patient to an urologist for further evaluation: Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physicians guide. Mississauga, ON: Astra Pharma Inc., 1996, p19. Microscopic hematuria ( 3 RBC per high power field (hpf) in 2 out of 3 different urine samples) Failure of medical therapy Chronic or recurrent urinary retention Patient requests surgical or minimally invasive treatment Hydronephrosis with or without elevated serum creatinine Elevated Residual ( 300 ml) Abnormal PSA Gross hematuria Suspicion of cancer on DRE Chronic or recurrent urinary tract infection Any symptoms that need further investigation

113 MODULE 2 113/ Diagnostic Algorithm The 2005 Canadian Guidelines for the Management of Benign Prostatic Hyperplasia contain an algorithm for the initial diagnosis of typical men who present with LUTS in daily clinical practice 150 (please refer to Module 4) 150. Nickel JC et al. Canadian Guidelines for the Management of Benign Prostatic Hyperplasia. Can J Urol. 2005;12:

114 MODULE 2 114/ Quiz 1. The normal prostate is about the size of a: a)Pea b)Marble c)Golf ball (Correct) d)Tennis ball

115 MODULE 2 115/ Hardening of the prostate on the DRE suggests: a)Prostate cancer (Correct) b)Bladder cancer c)BOO d)BPH BOO = Bladder Outlet Obstruction; BPH = Benign Prostatic Hyperplasia

116 MODULE 2 116/ Which of the following diagnostic tests is recommended by Canadian clinical practice guidelines in the routine evaluation of BPH? a)Urine cytology b)TRUS c)PSA (Correct) d)Serum creatinine BPH = Benign Prostatic Hyperplasia; TRUS = Transurethral Ultrasound; PSA = Prostate-Specific Antigen

117 MODULE 2 117/ PSA measurement is a useful surrogate estimate of prostate volume, because serum PSA levels increase on average by: a)0.1 ng/mL per gram of BPH tissue b)0.3 ng/mL per gram of BPH tissue (Correct) c)0.7 ng/mL per gram of BPH tissue d)1.0 ng/mL per gram of BPH tissue PSA = Prostate-Specific Antigen; BPH = Benign Prostatic Hyperplasia

118 MODULE 2 118/ Recent evidence indicates that cancer may occur in 22–24.5% of men with a serum PSA level of: a)0.3 ng/mL b)2.5 ng/mL (Correct) c)>4 ng/mL d)10 ng/mL PSA = Prostate-Specific Antigen


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