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Module 2: Diagnosis of BPH

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1 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 l’Université de Montréal Montréal, Québec Module 2: Diagnosis of Benign Prostatic Hyperplasia (BPH) The principle author for this module is Dr. Luc Valiquette, MD, FRCSC, Professor of surgery, urology, at the Department of surgery of Université de Montréal and Chief of urology at le Centre Hospitalier de l’Université de Montréal in Montréal, Quebec. Understanding BPH: From the Science to the Clinical Setting

2 Module 2: Diagnosis of BPH
2.1 Learning Objectives After reviewing this module, the learner will be better able to: Perform the differential diagnosis and alarm features used to identify benign prostatic hyperplasia (BPH) Identify which diagnostic assessments are appropriate at the initial evaluation of a typical patient with lower urinary tract symptoms (LUTS) Identify which optional diagnostic assessments are appropriate in selected patients 2.1 Learning Objectives After reviewing this module, the learner will be better able to: Perform the differential diagnosis and alarm features used to identify benign prostatic hyperplasia (BPH) Identify which diagnostic assessments are appropriate at the initial evaluation of a typical patient with lower urinary tract symptoms (LUTS) Identify which optional diagnostic assessments are appropriate in selected patients BPH = Benign Prostatic Hyperplasia; LUTS = Lower Urinary Tract Symptoms Understanding BPH: From the Science to the Clinical Setting

3 Module 2: Diagnosis of BPH
After reviewing this module, the learner will be better able to: Access clinical practice tools to evaluate BPH symptoms Implement CUA diagnostic algorithms in daily clinical practice Understand the appropriate roles of the family physician and recognize the time for specialist referral 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 Understanding BPH: From the Science to the Clinical Setting

4 Module 2: Diagnosis of BPH
2.2 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. 2.2 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. Fifth edition. Oxford: Health Press, 2005, p21. 1. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p21. Understanding BPH: From the Science to the Clinical Setting

5 Module 2: Diagnosis of BPH
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 life2 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. In the course of a basic evaluation to rule out this disease, BPH may be detected by symptomatology and, if the patient is willing, digital rectal examination 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. Fifth edition. Oxford: Health Press, 2005, p21. 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 Understanding BPH: From the Science to the Clinical Setting

6 Module 2: Diagnosis of BPH
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. 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 Understanding BPH: From the Science to the Clinical Setting

7 Module 2: Diagnosis of BPH
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. 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 Understanding BPH: From the Science to the Clinical Setting

8 Module 2: Diagnosis of BPH
2.3 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 2.3 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 lower urinary tract symptoms (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 Understanding BPH: From the Science to the Clinical Setting

9 Module 2: Diagnosis of BPH
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 treatment3 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 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. Fifth edition. Oxford: Health Press, 2005, p21. 4. AUA Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol. 2003;170: 5. Nickel JC, Herschorn S, Corcos J, Donnelly B, et al. Canadian guidelines for the management of benign prostatic hyperplasia. Can J Urol. 2005;12: 3. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p21. 4. AUA guideline on management of benign prostatic hyperplasia (2003) J. Urol. 2003;170: 5. Nickel JC et al. Canadian guidelines for the management of benign prostatic hyperplasia. Can J Urol. 2005;12: Understanding BPH: From the Science to the Clinical Setting

10 Module 2: Diagnosis of BPH
Key elements of the medical history cont’d: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 Other key elements of the medical history include: 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 over the counter (OTC) products Fitness for surgery 6. AUA Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol. 2003;170: 7. Nickel JC, Herschorn S, Corcos J, Donnelly B, et al. Canadian guidelines for the management of benign prostatic hyperplasia. Can J Urol. 2005;12: 6. AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170: 7. Nickel JC et al. Canadian guidelines for the management of benign prostatic hyperplasia. Can J Urol. 2005;12: OTC = Over the Counter Understanding BPH: From the Science to the Clinical Setting

11 The Identification of LUTS
Module 2: Diagnosis of BPH 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 men9 LUTS may occur in men with prostate cancer, prostatitis, or many other medical disorders10 The identification of LUTS BPH is characterized by a spectrum of obstructive and irritative symptoms, known as lower urinary tract symptoms (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.10 8. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. Fifth edition. Oxford: Health Press, 2005, p21. 9. Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physician’s guide. Mississauga, ON: Astra Pharma Inc., 1996, p19. 10. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. Fifth edition. Oxford: Health Press, 2005, p21. 8. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p21. 9. Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physician’s guide. Mississauga, ON: Astra Pharma Inc., 1996, p19. 10. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p21. BPH = Benign Prostatic Hyperplasia; LUTS = Lower Urinary Tract Symptoms Understanding BPH: From the Science to the Clinical Setting

12 Module 2: Diagnosis of BPH
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 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 Understanding BPH: From the Science to the Clinical Setting

13 Module 2: Diagnosis of BPH
In a significant number of men, non-prostatic causes of LUTS can be excluded on the basis of a medical history, physical examination, and urinalysis11 The severity of LUTS can be objectively measured by the following clinical assessment tools: International Prostate Symptom Score (IPSS) (or alternatively American Urological Association (AUA) symptom index) Disease-specific Quality of Life (QoL) questionnaire BPH Impact Index 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: International Prostate Symptom Score (IPSS) (or alternatively American Urological Association (AUA) symptom index) Disease-specific Quality of Life (QoL) questionnaire BPH Impact Index 11. Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physician’s guide. Mississauga, ON: Astra Pharma Inc., 1996, p19. 11. Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physician’s guide. Mississauga, ON: Astra Pharma Inc., 1996, p19. LUTS = Lower Urinary Tract Symptoms Understanding BPH: From the Science to the Clinical Setting

14 Table 2.1: BPH Related LUTS12,13*
Module 2: Diagnosis of BPH Table 2.1: BPH Related LUTS12,13* Obstructive symptoms Irritative 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 Table 2.1: BPH Related LUTS 12. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. Fifth edition. Oxford: Health Press, 2005, p Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physician’s guide. Mississauga, ON: Astra Pharma Inc., 1996, p19. *Note: some experts question the value of categorizing LUTS as obstructive or irritative 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 physician’s guide. Mississauga, ON: Astra Pharma Inc., 1996, p19. Understanding BPH: From the Science to the Clinical Setting

15 Module 2: Diagnosis of BPH
Practice Tip Prostate symptom scores offer a more objective measure of LUTS14 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. Practice Tip Prostate symptom scores offer a more objective measure of LUTS.14 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 physician’s guide. Mississauga, ON: Astra Pharma Inc., 1996, p19. 14. Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physician’s guide. Mississauga, ON: Astra Pharma Inc., 1996, p19. LUTS = Lower Urinary Tract Symptoms Understanding BPH: From the Science to the Clinical Setting

16 Module 2: Diagnosis of BPH
Physical Examination The physical examination must include a digital rectal examination (DRE) and focused neurological assessment.15 The physical examination is considered mandatory15,16 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 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 Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol. 2003;170: 16. Nickel JC, Herschorn S, Corcos J, Donnelly B, et al. Canadian Guidelines for the Management of Benign Prostatic Hyperplasia. Canadian guidelines for the management of benign prostatic hyperplasia. Can J Urol. 2005;12: 17. AUA Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol. 2003;170: 18. Chatelain C, Denis L, Foo JKT, Khoury J, et al. Benign Prostatic Hyperplasia. 5th international consultation on BPH. Recommendations of the International Scientific Committee: Evaluation and treatment of lower urinary tract symptoms (LUTS) in older men. Plymouth, UK: Health Publication, 2001:523. 19. Jepsen JV, Bruskewitz RC. Office evaluation of men with lower urinary tract symptoms. Urol Clinics N Am. 1998;25:547. 15. AUA guideline on management of benign prostatic hyperplasia (2003). J.Urol. 2003;170: 16. Nickel JC et al. Canadian guidelines for the management of benign prostatic hyperplasia. Can J Urol. 2005;12: 17. AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. Publication, 2001:523. 18. Chatelain C et al.Plymouth, UK: Health Publication, 2001:523. 19. Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25:547. Understanding BPH: From the Science to the Clinical Setting

17 Module 2: Diagnosis of BPH
Neurological findings may strongly suggest the presence of a neurogenic bladder20 The absence of neurological findings may help to exclude nervous system disorders, such as Parkinson’s disease or a cauda equina lesion, as the underlying cause of LUTS21 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 Parkinson’s disease or a cauda equina lesion, as the underlying cause of LUTS.21 20. Jepsen JV, Bruskewitz RC. Office evaluation of men with lower urinary tract symptoms. Urol Clinics N Am. 1998;25:547. 21. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. Fifth edition. Oxford: Health Press, 2005, p25. 20. Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25:547. 21. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p25. LUTS = Lower Urinary Tract Symptoms Understanding BPH: From the Science to the Clinical Setting

18 Module 2: Diagnosis of BPH
In addition to the DRE, the focused physical examination should include22: Palpation and percussion of abdomen and costovertebral angles to clinically exclude: Hydronephrosis Pyelonephritis Renal mass Bladder dilation 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 In addition to the DRE, the focused physical examination should include:22 Palpation and percussion of abdomen and costovertebral angles to clinically eliminate: Hydronephrosis Pyelonephritis Renal mass Bladder dilation 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. Office evaluation of men with lower urinary tract symptoms. Urol Clinics N Am. 1998;25:547. 23. Chatelain C, Denis L, Foo JKT, Khoury J, et al. Benign Prostatic Hyperplasia. 5th international consultation on BPH. Recommendations of the International Scientific Committee: Evaluation and treatment of lower urinary tract symptoms (LUTS) in older men. Plymouth, UK: Health Publication, 2001:523 24. Jepsen JV, Bruskewitz RC. Office evaluation of men with lower urinary tract symptoms. Urol Clinics N Am. 1998;25:547. 25. Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physician’s guide. Mississauga, ON: Astra Pharma Inc., 1996, p21-22. 22. Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25:547. 23. Chatelain C et al. Plymouth, UK: Health Publication, 2001:523. 24. Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25:547. 25. Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physician’s guide. Mississauga, ON: Astra Pharma Inc., 1996, p21-22. DRE = Digital Rectal Examination; BPH = Benign Prostatic Hyperplasia Understanding BPH: From the Science to the Clinical Setting

19 Module 2: Diagnosis of BPH
The physical examination should also include: Assessment of general appearance26 Skin colour and turgor Body weight, posture, build Edema, as a sign of renal insufficiency 4. Genital examination27 Routine palpation of penis, urethra, testicles and epididymis to rule out unrelated disease processes The physical examination should also include: 3. Assessment of general appearance26 Skin colour and turgor Body weight, posture, build Edema, as a sign of renal insufficiency 4. Genital examination27 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 physician’s guide. Mississauga, ON: Astra Pharma Inc., 1996, p21-22. 27. Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physician’s guide. Mississauga, ON: Astra Pharma Inc., 1996, p21-22. 26. Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physician’s guide. Mississauga, ON: Astra Pharma Inc., 1996, p21-22. 27. Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physician’s guide. Mississauga, ON: Astra Pharma Inc., 1996, p21-22. Understanding BPH: From the Science to the Clinical Setting

20 Module 2: Diagnosis of BPH
Practice Tip Urinary tract infections in older men may indicate significant BPH and bladder outlet obstruction28 Abdominal examination rarely identifies pathology but when abnormalities are discovered it is usually very significant29 Practice Tip Urinary tract infections in older men may indicate significant BPH and bladder outlet obstruction.28 Abdominal examination rarely identifies pathology but when abnormalities are discovered it is usually very significant.29 28. Jepsen JV, Bruskewitz RC. Office evaluation of men with lower urinary tract symptoms. Urol Clinics N Am. 1998;25:547. 29. Jepsen JV, Bruskewitz RC. Office evaluation of men with lower urinary tract symptoms. Urol Clinics N Am. 1998;25:547. 28. Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25:547. 29. Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25:547. BPH = Benign Prostatic Hyperplasia Understanding BPH: From the Science to the Clinical Setting

21 Digital Rectal Examination (DRE)
Module 2: Diagnosis of BPH Digital Rectal Examination (DRE) The digital rectal examination (DRE) is the cornerstone of the physical examination when BPH is suspected30 The primary purpose of this examination is to rule out prostate cancer, which also produces LUTS31 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 position33 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.33 30. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. Fifth edition. Oxford: Health Press, 2005, p25. 31. AUA Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol. 2003;170: 32. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. Fifth edition. Oxford: Health Press, 2005, p25. 33. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. Fifth edition. Oxford: Health Press, 2005, p25. 30. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p25. 31. AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170: 32. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p25. 33. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p25. LUTS – Lower Urinary Tract Symptoms; BPH = Benign Prostatic Hyperplasia Understanding BPH: From the Science to the Clinical Setting

22 Module 2: Diagnosis of BPH
The DRE estimates prostate34,35 Size Consistency Symmetry Smoothness Tenderness Anatomical limits The DRE can identify abnormalities suggestive of prostate cancer:36 Nodules Irregularities Firmness The DRE estimates prostate: 34,35 Size Consistence 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. Fifth edition. Oxford: Health Press, 2005, p25. 35. Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physician’s guide. Mississauga, ON: Astra Pharma Inc., 1996, p21-22. 36. Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physician’s guide. Mississauga, ON: Astra Pharma Inc., 1996, p21-22. 34. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p25. 35. Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physician’s guide. Mississauga, ON: Astra Pharma Inc., 1996, p21-22. 36. Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physician’s guide. Mississauga, ON: Astra Pharma Inc., 1996, p21-22. Understanding BPH: From the Science to the Clinical Setting

23 Module 2: Diagnosis of BPH
From the DRE, physicians can estimate the volume of prostates of ≤50 cm3 with reasonable accuracy37 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 measurement38,39 From the DRE, physicians can estimate the volume of prostates of ≤50 cm33 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.38,39 37. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. Fifth edition. Oxford: Health Press, 2005, p25. 38. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. Fifth edition. Oxford: Health Press, 2005, p25. 39. Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physician’s guide. Mississauga, ON: Astra Pharma Inc., 1996, p21-22. 37. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p25. 38. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p25. 39. Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physician’s guide. Mississauga, ON: Astra Pharma Inc., 1996, p21-22. Understanding BPH: From the Science to the Clinical Setting

24 Module 2: Diagnosis of BPH
Figure 2.1: Possible Findings on DRE Normal Tenderness Symmetrical Enlargement (BPH) Figure 2.1: Possible Findings on DRE Among the different findings on DRE, we can palpate a normal prostate, we can identify tenderness, symmetrical enlargement, asymmetry, induration or nodularity. Asymmetry Induration Nodularity DRE = Digital Rectal Exam Understanding BPH: From the Science to the Clinical Setting

25 Table 2.2: Clinical Findings of DRE40,41
Module 2: Diagnosis of BPH Table 2.2: Clinical Findings of DRE40,41 Size The normal prostate is slightly smaller than a golf ball (20cm3) In men with BPH: The prostate may rival the size of a tennis ball (>50cm3) 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. Table 2.2: Clinical Findings of DRE40,41 Some of the clinical findings on DRE are: According to size: The normal prostate is slightly smaller than a golf ball (20cm3) In men with BPH: The prostate may rival the size of a tennis ball (>50cm3) The prostate may be mildly, moderately or markedly enlarged. Regarding consistency: A prostate with BPH feels firm but smooth, symmetrical, and elastic. A palpable nodule, asymmetrical shape, or diffuse hardening may indicate cancer. If we look at the 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. Fifth edition. Oxford: Health Press, 2005, p Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physician’s guide. Mississauga, ON: Astra Pharma Inc., 1996, p21-22. 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 physician’s guide. Mississauga, ON: Astra Pharma Inc., 1996, p21-22. Understanding BPH: From the Science to the Clinical Setting

26 Module 2: Diagnosis of BPH
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) 45 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).45 42. Nickel JC, Herschorn S, Corcos J, Donnelly B, et al. Canadian Guidelines for the Management of Benign Prostatic Hyperplasia. Canadian guidelines for the management of benign prostatic hyperplasia. Can J Urol. 2005;12: 43. AUA Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol. 2003;170: 44. Chatelain C, Denis L, Foo JKT, Khoury J, et al. Benign Prostatic Hyperplasia. 5th international consultation on BPH. Recommendations of the International Scientific Committee: Evaluation and treatment of lower urinary tract symptoms (LUTS) in older men. Plymouth, UK: Health Publication, 2001:523. 45. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. Fifth edition. Oxford: Health Press, 2005, p25. 42. Nickel JC et al. Canadian guidelines for the management of benign prostatic hyperplasia. Can J Urol. 2005;12: 43. AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170: 44. Chatelain C et al. Plymouth, UK: Health Publication, 2001:523. 45. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p25. Understanding BPH: From the Science to the Clinical Setting

27 Table 2.3: Findings of Urinalysis46
Module 2: Diagnosis of BPH Table 2.3: Findings of Urinalysis46 Pyuria or bacteriuria Perform midstream urine culture Before any instrumentation of urinary tract, treat UTI. Hematuria Suspect Cancer Refer to urologist Table 2.3: Findings of Urinalysis46 46. Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physician’s guide. Mississauga, ON: Astra Pharma Inc., 1996, p24. 46. Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physician’s guide. Mississauga, ON: Astra Pharma Inc., 1996, p24. UTI – Urinary Tract Infection Understanding BPH: From the Science to the Clinical Setting

28 Prostate-specific Antigen (PSA)
Module 2: Diagnosis of BPH 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 future47 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.47 47. AUA Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol. 2003;170: 47. AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170: BPH = Benign Prostatic Hyperplasia Understanding BPH: From the Science to the Clinical Setting

29 Module 2: Diagnosis of BPH
Figure 2.2: PSA Predicts Prostate Growth PSA tertiles (ng/ml) Prostate Growth (baseline %) Figure 2.2: PSA Predicts Prostate Growth Adapted from Roehrborn CG et al. J Urol 2000;163:13-20. In the PLESS study over 48 months there is a change from baseline and the patients with higher PSA levels increases with that. Time (months) Adapted from Roehrborn CG et al. J Urol 2000;163:13-20. PSA = Prostate Specific Antigen Understanding BPH: From the Science to the Clinical Setting

30 Module 2: Diagnosis of BPH
PSA testing, with the DRE, is a relatively sensitive way to rule out prostate cancer in aging men48 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 cancer49 For that reason, PSA levels should not be interpreted alone but together with findings of the DRE50 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.50 48. Nickel JC, Herschorn S, Corcos J, Donnelly B, et al. Canadian Guidelines for the Management of Benign Prostatic Hyperplasia. Canadian guidelines for the management of benign prostatic hyperplasia. Can J Urol. 2005;12: 49. AUA Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol. 2003;170: 50. AUA Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol. 2003;170: 48. Nickel JC et al. Canadian Guidelines for the Management of Benign Prostatic Hyperplasia. Can J Urol. 2005;12: 49. AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170: 50. AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170: PSA = Prostate-Specific Antigen; DRE = Digital Rectal Examination Understanding BPH: From the Science to the Clinical Setting

31 Module 2: Diagnosis of BPH
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 Guidelines for Early Detection of Prostate Cancer DRE and PSA Test 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; CUA 1996; CPSM 1995; CMQ 1998; DRE = Digital Rectal Examination; PSA = Prostate-Specific Antigen Understanding BPH: From the Science to the Clinical Setting

32 Module 2: Diagnosis of BPH
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 measurement52 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.52 51. American Urology Association. Prostate-specific antigen (PSA) best practice policy. Oncology. 2000;14: 52. AUA Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol. 2003;170: 51. American Urology Association. Oncology. 2000;14: 52. AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170: PSA = Prostate-Specific Antigen Understanding BPH: From the Science to the Clinical Setting

33 Module 2: Diagnosis of BPH
PSA Testing – Yes or No? Pros Cons 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 PSA Testing – Yes or No? There should be a discussion with the patient regarding the value of PSA testing. Should it be done or not? Pros Increases cancer detection rate May detect cancers earlier No patient morbidity Estimate for prostate size in the absence of cancer Predicts BPH progression Cons Substantial false positive rate False positives trigger additional tests False negative rate Not proven to prolong survival 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. 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. Understanding BPH: From the Science to the Clinical Setting

34 Module 2: Diagnosis of BPH
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) 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, Herschorn S, Corcos J, Donnelly B, et al. Canadian Guidelines for the Management of Benign Prostatic Hyperplasia. Canadian guidelines for the management of benign prostatic hyperplasia. Can J Urol. 2005;12: 53. Nickel JC et al. Canadian Guidelines for the Management of Benign Prostatic Hyperplasia. Can J Urol. 2005;12: PSA = Prostate-Specific Antigen Understanding BPH: From the Science to the Clinical Setting

35 Module 2: Diagnosis of BPH
Figure 2.3: Prediction of Average Prostate Volume Based Upon Serum PSA and Age 70 65 60 55 50 45 40 35 30 Serum PSA, ng/ml Prostate Volume (cc) AGE (years) 75 Figure 2.3: Prediction of Average Prostate Volume Based Upon Serum PSA and Age Adapted from Roehrborn CG et al. Urology 1999;53: PSA measurement is a useful surrogate estimate of overall prostate volume. On average, serum PSA levels increase by 0.3 ng/mL per gram of BPH tissue.54 In general, in the absence of prostate cancer the higher the PSA level, the larger the prostate. 54. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. Fifth edition. Oxford: Health Press, 2005, pp12-13,26-28. Adapted from Roehrborn CG et al. Urology 1999;53: PSA = Prostate-Specific Antigen Understanding BPH: From the Science to the Clinical Setting

36 Module 2: Diagnosis of BPH
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 progression55,56 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.55 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.56,57 55. Roehrborn CG, Boyle P, Bergner D, Gray T, et al for the PLESS group. Serum prostate-specific antigen and prostate volume predict long-term changes in symptoms and flow rate: results of a four-year, randomized trial comparing finasteride versus placebo. Urology. 1999;54:662-9. 56. Roehrborn CG, Boyle P, Bergner D, Gray T, et al for the PLESS group. Serum prostate-specific antigen and prostate volume predict long-term changes in symptoms and flow rate: results of a four-year, randomized trial comparing finasteride versus placebo. Urology. 1999;54:662-9. 57. Bartsch G, Fitzpatrick JM, Schalken JA, Isaacs J, et al. Consensus statement: the role of prostate-specific antigen in managing the patient with benign prostatic hyperplasia. BJU International. 2004;93(S1):27-9. 54. Roehrborn CG et al for the PLESS group. Urology. 1999;54:662-9. 55. Roehrborn CG et al for the PLESS group. Urology. 1999;54:662-9. 56. Bartsch G et al. BJU International. 2004;93(S1):27-9. PSA = Prostate-Specific Antigen; BPH = Benign Prostatic Hyperplasia Understanding BPH: From the Science to the Clinical Setting

37 Figure 2.4: PSA and Symptoms*,**
Module 2: Diagnosis of BPH Figure 2.4: PSA and Symptoms*,** 0.0 1 2 3 4 -1.0 -2.0 -3.0 -4.0 -5.0 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 Figure 2.4: PSA and Symptoms Adapted from Roehrborn CG et al. Urology 1999;54: If you look at this graph from the PLESS study and if we put on a chart the patients who were on placebo and we divide it into 3 groups, whether they had a PSA between 0 and 1.3ng/mL at baseline, 1.4 to 3.2ng/mL or larger than 3.3ng/mL, we see that patients in the lower tertiles have improvement initially and this continues. Patients of the two other tertiles have an initial improvement, but over time their symptoms deteriorate according to PSA. Therefore, PSA is a good indicator of progression of 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):662-9. Understanding BPH: From the Science to the Clinical Setting

38 Module 2: Diagnosis of BPH
Figure 2.5: Bother and PSA -0.5 -1 -1.5 -2 -2.5 -3 PSA tertiles (ng/mL) Mean (SE) change in bother score Figure 2.5: Bother and PSA Adapted from Bruskewitz R et al. Urology 1999;54: In the placebo arm of the PLESS Study, the average bother score of men with a baseline PSA in the lower range tertile (0-1.3 ng/mL) showed no significant deterioration in their average bother score. Men in the upper 2 tertiles (≥1.4ng/mL) had progression of their bother score over the 4 years of the study.58 58. Bruskewitz R, Girman CJ, Fowler J et al. Effect of finasteride on bother and other health-related quality of life aspects associated with benign prostatic hyperplasia. Urology 1999;54:670–678. PSA 0 – 1.3 PSA 1.4 – 3.2 PSA Year of follow up Adapted from Bruskewitz R et al. Urology 1999;54: ; PSA = Prostate-Specific Antigen Understanding BPH: From the Science to the Clinical Setting

39 Figure 2.6: Peak Flow Rates and PSA
Module 2: Diagnosis of BPH Figure 2.6: Peak Flow Rates and PSA Months 1.5 1 0.5 -0.5 -1 -1.5 PSA tertiles (ng/ml) Figure 2.6: Peak Flow Rates and PSA Adapted from Roehrborn CG et al. Urology 1999;54: In the placebo arm of PLESS, lower average peak flow rates were associated with higher PSA scores. PSA 0–1.2 PSA 1.3–3.2 PSA 3.2–10 Adapted from Roehrborn CG et al. Urology 1999;54: ; PSA = Prostate-Specific Antigen Understanding BPH: From the Science to the Clinical Setting

40 Module 2: Diagnosis of BPH
Figure 2.7: Incidence of Surgery and AUR over 4 years by PSA Tertiles 21 (Placebo-treated BPH) Baseline PSA tertiles PSA 0–1.2 ng/ml PSA 1.3–3.2 ng/ml PSA >3.2 ng/ml 18 14.6% 15 Incidence (%) 12.6% 12 9.9% 9 Figure 2.7: Incidence of Surgery and Acute Urinary Retention (AUR) by PSA Tertiles Adapted Roerhborn CG. AUA 2005. In the placebo arm of PLESS, higher PSA scores were associated with higher rates of AUR and increased need for surgery. 6.2% 5.8% 6 2.9% 3 Surgery AUR Adapted from Roerhborn CG. AUA 2005. Understanding BPH: From the Science to the Clinical Setting

41 Figure 2.8: MTOPS Subanalysis PSA and Risk of BPH Progression
Module 2: Diagnosis of BPH Figure 2.8: MTOPS Subanalysis PSA and Risk of BPH Progression 3.1 2.8 0.3 0.8 5.9 4.5 1 1.8 2 3 4 5 6 7 Overall Progression Symptom AUR Inv. Therapy p = p = <1.6 ng/ml ≥1.6 ng/ml Rate per 100 PYR p = Figure 2.8: Medical Therapy of Prostatic Symptoms Trial (MTOPS) Subanalysis McConnell JD et al. J Urol. 2003;169(suppl):332. The MTOPS trial showed that PSA is a strong predictor of BPH progression. Men with a baseline PSA of greater or equal to 1.6 ng/mL have a significantly higher risk of overall progression, specifically symptom progression, occurrence of AUR and risk of invasive surgery. p = McConnell JD et al. J Urol. 2003;169(suppl):332. Understanding BPH: From the Science to the Clinical Setting

42 Module 2: Diagnosis of BPH
Practice Tip The risk of BPH progression is higher in men with a PSA >1.4 ng/mL59 PSA alone is insufficient to detect localized prostate cancer60 Practice Tip The risk of BPH progression is higher in men with a PSA >1.4 ng/mL.59 PSA alone is insufficient to detect localized prostate cancer.60 59. Kirby RS. The prostate: small gland, big problem: A guide to the prostate, prostate disorders and their treatments. Abingdon, UK;Prostate Research Campaign UK, 2000, pp53. 60. Jepsen JV, Bruskewitz RC. Office evaluation of men with lower urinary tract symptoms. Urol Clinics N Am. 1998;25:548. 59. Kirby RS. UK;Prostate Research Campaign UK, 2000, pp53. 60. Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25:548. BPH = Benign Prostatic Hyperplasia; PSA = Prostate-Specific Antigen Understanding BPH: From the Science to the Clinical Setting

43 Module 2: Diagnosis of BPH
Figure 2.9: Prostate-specific Antigen (PSA) and How it Gets into the Blood Stream Figure 2.9: Prostate-specific Antigen (PSA) and How it Gets into the Blood Stream Adapted from Kirby & McConnell, 2005, p.28 Prostatic epithelial cells release prostate-specific antigen (PSA), a glycoprotein, into the bloodstream. The normal prostate releases small amounts of PSA (<4 ng/mL), about one-fifth of which binds to proteins, such as antichymotrypsin (ACT). A higher PSA level predicts a greater number of actively secreting epithelial cells. In men with BPH, moderate amounts of PSA enter the bloodstream and a small proportion binds to ACT. As a result, a large proportion of serum PSA levels are free.61 61. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. Fifth edition. Oxford: Health Press, 2005, pp12-13,26-28. Adapted from Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p28. Understanding BPH: From the Science to the Clinical Setting

44 More Information About Serum PSA
Module 2: Diagnosis of BPH 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 volume62 (Refer to Figure 2.2) 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, McConnell J, Bonilla J, Rosenblatt S, et al for the PLESS group. Serum prostate specific antigen is a strong predictor of future prostate growth in men with benign prostatic hyperplasia. J Urol. 2000;163:13. 62. Roehrborn CG et al for the PLESS group. J Urol. 2000;163:13. BPH = Benign Prostatic Hyperplasia; PSA = Prostate-Specific Antigen Understanding BPH: From the Science to the Clinical Setting

45 Module 2: Diagnosis of BPH
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. These men had an overall growth rate in prostate volume of 1.8 cc 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 Understanding BPH: From the Science to the Clinical Setting

46 Module 2: Diagnosis of BPH
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 BPH63 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. 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, Boyle P, Bergner D, Gray T, et al for the PLESS group. Serum prostate-specific antigen and prostate volume predict long-term changes in symptoms and flow rate: results of a four-year, randomized trial comparing finasteride versus placebo. Urology. 1999;54:662-9. 63. Roehrborn CG et al for the PLESS group. Urology. 1999;54: BPH = Benign Prostatic Hyperplasia; PSA = Prostate-Specific Antigen Understanding BPH: From the Science to the Clinical Setting

47 Module 2: Diagnosis of BPH
Age-specific serum PSA reference ranges were first established in 1993, based on a 2-year study of a community-based population of healthy white men in Olmstead County, Minnesota, USA64 This study determined that serum PSA concentration is directly correlated with patient age and prostate volume. 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, Jacobsen SJ, Chute CG, Guess HA, et al. Serum prostate-specific antigen in a community-based population of healthy men. JAMA. 1993;270:860-4. 64. Oesterling JE et al. JAMA. 1993;270:860-4. PSA = Prostate-Specific Antigen Understanding BPH: From the Science to the Clinical Setting

48 Module 2: Diagnosis of BPH
Subsequent studies found that PSA levels vary in different racial groups, with black men having higher PSA levels than whites65 Subsequent studies found that PSA levels vary in different racial groups, with black men having higher PSA levels than whites65 65. Morgan TO, Jacobsen SJ, McCarthy WF, Jacobson DJ, et al. Age-specific reference ranges for serum prostate-specific antigen in black men. N Engl J Med. 1996;335: 65. Morgan TO et al. N Engl J Med. 1996;335: PSA = Prostate-Specific Antigen Understanding BPH: From the Science to the Clinical Setting

49 Table 2.4: Relative Risk of Prostate Enlargement by PSA Level
Module 2: Diagnosis of BPH Table 2.4: Relative Risk of Prostate Enlargement by PSA Level Table 2.4: Relative Risk of Prostate Enlargement by PSA Level Wright JE, Fang J, Metter EJ, Partin AW, et al. Prostate-specific antigen predicts the long-term risk of prostate enlargement: results from the longitudinal study of aging. J Urol. 2002;167:2485. In the Baltimore Longitudinal Study of Aging66 the relative risk of prostate enlargement in men with BPH from 50 to 59.9 years of age increased from 5- to 9-fold when PSA levels exceeded 0.8 ng/mL. In men from 60 to 69.9 years of age, this relative risk increased to 11-fold when the PSA exceeded 1.70 ng/mL versus men with a PSA of ≤0.50 ng/mL. 66. Wright JE, Fang J, Metter EJ, Partin AW, et al. Prostate-specific antigen predicts the long-term risk of prostate enlargement: results from the longitudinal study of aging. J Urol. 2002;167:2485. *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 Understanding BPH: From the Science to the Clinical Setting

50 Module 2: Diagnosis of BPH
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 age67 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.67 67. Roehrborn CG, Boyle P, Gould L, Waldstreicher J. Serum prostate-specific antigen as a predictor of prostate volume in men with benign prostatic hyperplasia. Urology. 1999;53:581-9. 67. Roehrborn CG et al. Urology. 1999;53:581-9. BPH = Benign Prostatic Hyperplasia PSA = Prostate-Specific Antigen Understanding BPH: From the Science to the Clinical Setting

51 Table 2.5: Age-Specific Ranges* for Serum PSA Levels in Healthy Men68
Module 2: Diagnosis of BPH Table 2.5: Age-Specific Ranges* for Serum PSA Levels in Healthy Men68 Age (years) PSA (ng/mL) 40-49 50-59 60-69 70-79 0.0–2.5 0.0–3.5 0.0–4.5 0.0–6.5 Prostate volume (mL) 13–51 15-60 17-70 20-82 PSA density (ng/mL per mL) 0.0–0.08 0.0–0.10 0.0–0.11 0.0–0.13 Table 2.5: Age-Specific Ranges* for Serum PSA Levels in Healthy Men68 68. Oesterling JE, Jacobsen SJ, Chute CG, Guess HA, et al. Serum prostate-specific antigen in a community-based population of healthy men. JAMA. 1993;270:860-4. *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. 68. Oesterling JE et al. JAMA. 1993;270: ; PSA = Prostate-Specific Antigen Understanding BPH: From the Science to the Clinical Setting

52 Module 2: Diagnosis of BPH
Table 2.6: Age-Specific Reference Ranges for Serum PSA Levels in Healthy Men of Different Race69 Age (years) White Black 40-49 0.0–2.5 0.0–2.0 50-59 0.0–3.5 0.0–4.0 60-69 0.0–4.5 70-79 0.0–5.5 Table 2.6: Age-specific reference ranges for serum PSA levels in healthy men of different race69 69. Wright JE, Fang J, Metter EJ, Partin AW, et al. Prostate-specific antigen predicts the long-term risk of prostate enlargement: results from the longitudinal study of aging. J Urol. 2002;167:2485. 70. Morgan TO et al. Age-specific reference ranges for serum prostate-specific antigen in black men. N Engl J Med. 1996;335:309. Note: This is based on the 5th percentile of the distribution of PSA levels70 69. Wright JE et al. J Urol. 2002;167:2485. 70. Morgan TO et al.. N Engl J Med. 1996;335:309. PSA = Prostate-Specific Antigen Understanding BPH: From the Science to the Clinical Setting

53 Module 2: Diagnosis of BPH
Table 2.7: Age-Specific Criteria for Detection of Prostate Volume ≥40 cc71* Age (years) Serum PSA level (ng/mL) 50-59 >1.6 60-69 >2.0 70+ >2.3 Table 2.7: Age-Specific Criteria for Detection of Prostate Volume ≥40 cc71* Adapted from Roehrborn CG et al. Urology. 1999;53:581. 71. Roehrborn CG, Boyle P, Gould L, Waldstreicher J. Serum prostate-specific antigen as a predictor of prostate volume in men with benign prostatic hyperplasia. Urology. 1999;53:581-9. *These criteria have a specificity of 70% and sensitivity of 65–70%. 71.Roehrborn CG et al. Urology. 1999;53:581-9. Adapted from Roehrborn CG et al. Urology. 1999;53:581. PSA = Prostate-Specific Antigen Understanding BPH: From the Science to the Clinical Setting

54 Use of PSA as a Screening Tool
Module 2: Diagnosis of BPH 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 analysis72 Serum PSA levels are not specific enough to distinguish between BPH and localized prostate cancer73 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 Europe74 Use of PSA as a Screening Tool The 2005 Canadian Guidelines for the Management of Benign Prostatic Hyperplasia (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.74 72. Nickel JC, Herschorn S, Corcos J, Donnelly B, et al. Canadian Guidelines for the Management of Benign Prostatic Hyperplasia. Canadian guidelines for the management of benign prostatic hyperplasia. Can J Urol. 2005;12: 73. Jepsen JV, Bruskewitz RC. Office evaluation of men with lower urinary tract symptoms. Urol Clinics N Am. 1998;25:548. 74. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. Fifth edition. Oxford: Health Press, 2005, p29. 72. Nickel JC et al. Canadian guidelines for the management of benign prostatic hyperplasia. Can J Urol. 2005;12: 73. Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25:548. 74. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p29. BPH = Benign-Prostatic Hyperplasia; PSA = Prostate-Specific Antigen Understanding BPH: From the Science to the Clinical Setting

55 2.4 Optional Diagnostic Tests
Module 2: Diagnosis of BPH 2.4 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 2.4 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 Understanding BPH: From the Science to the Clinical Setting

56 Module 2: Diagnosis of BPH
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 situ75 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.75 75. AUA Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol. 2003;170:532. 75. AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170:532. Understanding BPH: From the Science to the Clinical Setting

57 Module 2: Diagnosis of BPH
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)77 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).77 76. Jepsen JV, Bruskewitz RC. Office evaluation of men with lower urinary tract symptoms. Urol Clinics N Am. 1998;25:549. 77. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. Fifth edition. Oxford: Health Press, 2005, p31-3 76. Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25:549. 77. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p31-3 Understanding BPH: From the Science to the Clinical Setting

58 Module 2: Diagnosis of BPH
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 bladder78 This test is not indicated in initial patient evaluations, unless the patient has renal failure. 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, Denis L, Foo JKT, Khoury J, et al. Benign Prostatic Hyperplasia. 5th international consultation on BPH. Recommendations of the International Scientific Committee: Evaluation and treatment of lower urinary tract symptoms (LUTS) in older men. Plymouth, UK: Health Publication, 2001:524 78. Chatelain C et al. Plymouth, UK: Health Publication, 2001:524 Understanding BPH: From the Science to the Clinical Setting

59 Module 2: Diagnosis of BPH
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 prostate79,80 Hormonal therapy Thermotherapy Transurethral Needle Ablation (TUNA) Transurethral Incision of the Prostate (TUIP) Transurethral Resection of the Prostate (TURP) Stents 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, Denis L, Foo JKT, Khoury J, et al. Benign Prostatic Hyperplasia. 5th international consultation on BPH. Recommendations of the International Scientific Committee: Evaluation and treatment of lower urinary tract symptoms (LUTS) in older men. Plymouth, UK: Health Publication, 2001:524. 80. AUA Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol. 2003;170:534. 79. Chatelain C et al. Plymouth, UK: Health Publication, 2001:524. 80. AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170:534. Understanding BPH: From the Science to the Clinical Setting

60 Module 2: Diagnosis of BPH
Figure 2.10: Abdominal Ultrasound Scan Showing Post-void Residual Urine and an Enlarged Benign Prostate Bulging into the Bladder Figure 2.10: Abdominal Ultrasound Scan Showing Post-void Residual Urine and an Enlarged Benign Prostate Bulging into the Bladder Source: Kirby & McConnell, 2005, p31 Source: Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p31. Understanding BPH: From the Science to the Clinical Setting

61 Transrectal Ultrasound (TRUS)
Module 2: Diagnosis of BPH Transrectal Ultrasound (TRUS) Although prostate volume correlates with LUTS in large populations of patients, individual findings may differ81 TRUS is an easy to use, non-invasive, and easily reproducible technique that assesses prostate size, shape, and volume82 The determination of prostate volume has prognostic value for the natural history of BPH and patient’s response to 5α-reductase inhibitors83 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 patient’s response to 5a-reductase inhibitors.83 81. Jepsen JV, Bruskewitz RC. Office evaluation of men with lower urinary tract symptoms. Urol Clinics N Am. 1998;25: 82. Jepsen JV, Bruskewitz RC. Office evaluation of men with lower urinary tract symptoms. Urol Clinics N Am. 1998;25: 83. AUA Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol. 2003;170:534. 81. Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25: 82. Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25: 83. AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170:534. LUTS = Lower Urinary Tract Symptoms; BPH = Benign Prostatic Hyperplasia Understanding BPH: From the Science to the Clinical Setting

62 Module 2: Diagnosis of BPH
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 practice84 Combined with biopsy, it is the method of choice to rule out prostate cancer and other differential diagnoses85,86 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 therapy88 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 with bladder outflow obstruction (BOO) due to BPH.87 This evaluation is not routinely necessary before watchful waiting or medical therapy.88 84. Jepsen JV, Bruskewitz RC. Office evaluation of men with lower urinary tract symptoms. Urol Clinics N Am. 1998;25: 85. AUA Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol. 2003;170:534. 86. Chatelain C, Denis L, Foo JKT, Khoury J, et al. Benign Prostatic Hyperplasia. 5th international consultation on BPH. Recommendations of the International Scientific Committee: Evaluation and treatment of lower urinary tract symptoms (LUTS) in older men. Plymouth, UK: Health Publication, 2001:524. 87. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. Fifth edition. Oxford: Health Press, 2005, p32-33. 88. Jepsen JV, Bruskewitz RC. Office evaluation of men with lower urinary tract symptoms. Urol Clinics N Am. 1998;25: 84. Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25: 85. AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170:534. 86. Chatelain C et al. Plymouth, UK: Health Publication, 2001:524. 87. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p32-33. 88. Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25: DRE = Digital Rectal Examination; PSA = Prostate-Specific Antigen; BPH = Benign Prostatic Hyperplasia Understanding BPH: From the Science to the Clinical Setting

63 Module 2: Diagnosis of BPH
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 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 Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol. 2003;170:534. 90. Chatelain C, Denis L, Foo JKT, Khoury J, et al. Benign Prostatic Hyperplasia. 5th international consultation on BPH. Recommendations of the International Scientific Committee: Evaluation and treatment of lower urinary tract symptoms (LUTS) in older men. Plymouth, UK: Health Publication, 2001:524. 89. AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170:534. 90. Chatelain C et al. Plymouth, UK: Health Publication, 2001:524. Understanding BPH: From the Science to the Clinical Setting

64 Module 2: Diagnosis of BPH
Figure 2.11: Transrectal Ultrasound-guided Biopsy of the Prostate with an Automated Biopsy Device Figure 2.11: Transrectal Ultrasound-guided Biopsy of the Prostate with an Automated Biopsy Device Adapted from Kirby & McConnell, 2005, p32 Adapted from Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p32. Understanding BPH: From the Science to the Clinical Setting

65 Module 2: Diagnosis of BPH
Serum Creatinine In the Canadian guidelines serum creatinine determination is optional, based on the patient’s clinical situation, e.g., severe symptoms, complications, AUR, scheduled for surgery, etc91 In the American Urology Association (AUA) guidelines, serum creatinine measurement is no longer recommended on initial evaluation of typical patients92 The AUA decision was based on a review of several large BPH trials with more than 10,000 patient-years of follow-up92 Serum Creatinine In the Canadian guidelines serum creatinine determination is optional, based on the patient’s clinical situation, e.g., severe symptoms, complications, acute urinary retention (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.92 91. AUA Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol. 2003;170:532. 92. Nickel JC, Herschorn S, Corcos J, Donnelly B, et al. Canadian Guidelines for the Management of Benign Prostatic Hyperplasia. Canadian guidelines for the management of benign prostatic hyperplasia. Can J Urol. 2005;12: 91. 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: BPH = Benign Prostatic Hyperplasia Understanding BPH: From the Science to the Clinical Setting

66 Module 2: Diagnosis of BPH
If the patient’s 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 If the patient’s 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. Understanding BPH: From the Science to the Clinical Setting

67 Module 2: Diagnosis of BPH
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 stones93 Men with LUTS do not have a higher prevalence of these conditions than the normal population94 Ultrasound is better than IVU at detecting hydronephrosis, renal stones, and tumours. 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. Office evaluation of men with lower urinary tract symptoms. Urol Clinics N Am. 1998;25: 94. Jepsen JV, Bruskewitz RC. Office evaluation of men with lower urinary tract symptoms. Urol Clinics N Am. 1998;25:550. 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 Understanding BPH: From the Science to the Clinical Setting

68 Module 2: Diagnosis of BPH
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 BPH95 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.95 95. Jepsen JV, Bruskewitz RC. Office evaluation of men with lower urinary tract symptoms. Urol Clinics N Am. 1998;25:550. 95. Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25:550. BPH = Benign-Prostatic Hyperplasia Understanding BPH: From the Science to the Clinical Setting

69 Module 2: Diagnosis of BPH
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 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, Denis L, Foo JKT, Khoury J, et al. Benign Prostatic Hyperplasia. 5th international consultation on BPH. Recommendations of the International Scientific Committee: Evaluation and treatment of lower urinary tract symptoms (LUTS) in older men. Plymouth, UK: Health Publication, 2001:525. 96. Chatelain C et al. Plymouth, UK: Health Publication, 2001:525. LUTS = Lower Urinary Tract Symptoms Understanding BPH: From the Science to the Clinical Setting

70 Module 2: Diagnosis of BPH
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 strictures97 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.97 97. Jepsen JV, Bruskewitz RC. Office evaluation of men with lower urinary tract symptoms. Urol Clinics N Am. 1998;25:550. 97. Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25:550. Understanding BPH: From the Science to the Clinical Setting

71 Module 2: Diagnosis of BPH
The value of cytoscopy has not been documented in men with BPH98 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 therapy99 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.99 98. Jepsen JV, Bruskewitz RC. Office evaluation of men with lower urinary tract symptoms. Urol Clinics N Am. 1998;25:550. 99. Jepsen JV, Bruskewitz RC. Office evaluation of men with lower urinary tract symptoms. Urol Clinics N Am. 1998;25:550. 98. Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25:550. 99. Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25:550. BPH = Benign Prostatic Hyperplasia; LUTS = Lower Urinary Tract Symptoms Understanding BPH: From the Science to the Clinical Setting

72 Urine Flow Study (Uroflowmetry)
Module 2: Diagnosis of BPH 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 BPH100 Urine Flow Study (Uroflowmetry) The electronic measurement of urine flow (uroflowmetry) is helpful in identifying men with lower urinary tract symptoms (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 benign prostatic hyperplasia (BPH).100 100. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. Fifth edition. Oxford: Health Press, 2005, p30-31. 100. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p LUTS = Lower Urinary Tract Symptomsl BPH = Benign Prostatic Hyperplasia Understanding BPH: From the Science to the Clinical Setting

73 Module 2: Diagnosis of BPH
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 men101 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 BOO102 The specificity and sensitivity of uroflowmetry is low103 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 bladder outlet obstruction (BOO).102 The specificity and sensitivity of uroflowmetry is low.103 101. Jepsen JV, Bruskewitz RC. Office evaluation of men with lower urinary tract symptoms. Urol Clinics N Am. 1998;25:548. 102. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. Fifth edition. Oxford: Health Press, 2005, p30-31. 103. Jepsen JV, Bruskewitz RC. Office evaluation of men with lower urinary tract symptoms. Urol Clinics N Am. 1998;25:548. 101. Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25:548. 102. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p30-31. 103. Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25:548. BOO = Bladder Outlet Obstruction Understanding BPH: From the Science to the Clinical Setting

74 Module 2: Diagnosis of BPH
This test poorly predicts the failure of watchful waiting and a patient’s response to medical therapy104 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 collected105,106,107 This test poorly predicts the failure of watchful waiting and a patient’s 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.105,106,107 104. AUA Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol. 2003;170:533. 105. AUA Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol. 2003;170:533. 106. Chatelain C, Denis L, Foo JKT, Khoury J, et al. Benign Prostatic Hyperplasia. 5th international consultation on BPH. Recommendations of the International Scientific Committee: Evaluation and treatment of lower urinary tract symptoms (LUTS) in older men. Plymouth, UK: Health Publication, 2001:524. 107. Jepsen JV, Bruskewitz RC. Office evaluation of men with lower urinary tract symptoms. Urol Clinics N Am. 1998;25:548. 104. AUA guideline on management of benign prostatic hyperplasia (2003). Urol. 2003;170:533. 105. AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170:533. 106. Chatelain C et al. Plymouth, UK: Health Publication, 2001:524. 107. Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25:548. BPH = Benign Prostatic Hyperplasia Understanding BPH: From the Science to the Clinical Setting

75 Module 2: Diagnosis of BPH
Practice Tip The patient should obtain the Qmax from a normal voiding position, in private, when he feels the urge to void108 Uroflow is not necessary for treatment decisions in the majority of BPH patients. 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. 108. Jepsen JV, Bruskewitz RC. Office evaluation of men with lower urinary tract symptoms. Urol Clinics N Am. 1998;25:548. 108. Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25:548. Understanding BPH: From the Science to the Clinical Setting

76 Urodynamics (Pressure-Flow Study)
Module 2: Diagnosis of BPH 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 rate109 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 important110, 111 The 5th International Consultation on BPH recommends pressure- flow studies in all men with a Qmax >10mL/s, when surgery is being considered. 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. 109. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. Fifth edition. Oxford: Health Press, 2005, p31-2. 110. Chatelain C, Denis L, Foo JKT, Khoury J, et al. Benign Prostatic Hyperplasia. 5th international consultation on BPH. Recommendations of the International Scientific Committee: Evaluation and treatment of lower urinary tract symptoms (LUTS) in older men. Plymouth, UK: Health Publication, 2001:524. 111. AUA Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol. 2003;170:534. 109. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p31-2. 110. Chatelain C et al. Plymouth, UK: Health Publication, 2001:524. 111. AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170:534. BPH = Benign Prostatic Hyperplasia Understanding BPH: From the Science to the Clinical Setting

77 Module 2: Diagnosis of BPH
Urodynamics offer the greatest benefits in men with a concomitant neurologic disease that affects bladder function, e.g., stroke, Parkinson’s disease, diabetic neuropathy, or a history of prior surgery for BPH112 Urodynamic studies are not useful to predict the outcome of medical therapy113 A small catheter is inserted urethrally or suprapubically to measure bladder pressure. This procedure may cause some discomfort114 The most important parameter of urodynamic tests is detrusor pressure (pdet) at the time of peak urinary flow (Qmax). Urodynamics offer the greatest benefits in men with a concomitant neurologic disease that affects bladder function, e.g., stroke, Parkinson’s 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 Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol. 2003;170:534. 113. Jepsen JV, Bruskewitz RC. Office evaluation of men with lower urinary tract symptoms. Urol Clinics N Am. 1998;25:548-9. 114. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. Fifth edition. Oxford: Health Press, 2005, p31-2. 112 AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170:534. 113. Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25:548-9. 114. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p31-2. Understanding BPH: From the Science to the Clinical Setting

78 Post-Void Residual Urine (PVR)
Module 2: Diagnosis of BPH Post-Void Residual Urine (PVR) For patients in whom the clinical picture is unclear, the assessment of post-void residual urine (PVR) may be helpful115 This optional test cannot confirm or exclude a diagnosis of BPH116 There is no evidence to suggest that it has value for predicting the outcome of treatment in patients with PVR of <300 mL117 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.117 115. Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physician’s guide. Mississauga, ON: Astra Pharma Inc., 1996, p24. 116. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. Fifth edition. Oxford: Health Press, 2005, p30-31. 117. Chatelain C, Denis L, Foo JKT, Khoury J, et al. Benign Prostatic Hyperplasia. 5th international consultation on BPH. Recommendations of the International Scientific Committee: Evaluation and treatment of lower urinary tract symptoms (LUTS) in older men. Plymouth, UK: Health Publication, 2001:524. 115. Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physician’s guide. Mississauga, ON: Astra Pharma Inc., 1996, p24. 116. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p30-31. 117. Chatelain C et al. Plymouth, UK: Health Publication, 2001:524. Understanding BPH: From the Science to the Clinical Setting

79 Table 2.8: PVRs Measured within Minutes of Voiding
Module 2: Diagnosis of BPH Table 2.8: PVRs Measured within Minutes of Voiding <50ml Normal 50-200ml Acceptable depending on clinical situation >200ml Usually abnormal and should be referred to a urologist for an evaluation Table 2.8: PVRs Measured within Minutes of Voiding AHCPR guidelines 1994 According to the AHCPR guidelines published in 1994 PVR’s should be measured within minutes of voiding and should be considered normal if less than 50mL. It should be considered abnormal usually and mandate a referral to a urologist if over 200mL and between mL should be considered acceptable depending on the clinical situation. AHCPR guidelines 1994 PVR = post-void residual urine Understanding BPH: From the Science to the Clinical Setting

80 Module 2: Diagnosis of BPH
During the physical examination, the physician can check for bladder distention (significant PVR) by suprapubic percussion and palpation118 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 assessment119 If the first PVR urine volume is significant or suggest a change in treatment plan, the assessment should be repeated120 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.120 118. Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physician’s guide. Mississauga, ON: Astra Pharma Inc., 1996, p24. 119. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. Fifth edition. Oxford: Health Press, 2005, p30-31. 120. Chatelain C, Denis L, Foo JKT, Khoury J, et al. Benign Prostatic Hyperplasia. 5th international consultation on BPH. Recommendations of the International Scientific Committee: Evaluation and treatment of lower urinary tract symptoms (LUTS) in older men. Plymouth, UK: Health Publication, 2001:524. 118. Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physician’s guide. Mississauga, ON: Astra Pharma Inc., 1996, p24. 119. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p30-31. 120. Chatelain C et al. Plymouth, UK: Health Publication, 2001:524. PVR = post-void residual urine Understanding BPH: From the Science to the Clinical Setting

81 Module 2: Diagnosis of BPH
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 waiting121,122 PVR values above 200–300 mL may indicate a higher risk of acute urinary retention (AUR) and a greater need for invasive surgery123 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.123 121. Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physician’s guide. Mississauga, ON: Astra Pharma Inc., 1996, p24. 122. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. Fifth edition. Oxford: Health Press, 2005, p30-31. 123. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. Fifth edition. Oxford: Health Press, 2005, p30-31. 121. Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physician’s guide. Mississauga, ON: Astra Pharma Inc., 1996, p24. 122. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p30-31. 123. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p30-31. PVR = post-void residual urine Understanding BPH: From the Science to the Clinical Setting

82 Module 2: Diagnosis of BPH
Large PVR volumes may be associated with bladder dysfunction and neurological disease, and a slightly less favorable treatment response124 Patients with a consistently high PVR of >300 mL should be referred to an urologist for further evaluation, which may eventually lead to transurethral surgery125 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.125 124. Jepsen JV, Bruskewitz RC. Office evaluation of men with lower urinary tract symptoms. Urol Clinics N Am. 1998;25:550. 125. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. Fifth edition. Oxford: Health Press, 2005, p30-31. 124. Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25:550. 125. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p30-31. PVR = post-void residual urine Understanding BPH: From the Science to the Clinical Setting

83 Module 2: Diagnosis of BPH
Practice Tip There is no demonstrable correlation between PVR and UTIs in men with BPH126 Many patients maintain a fairly large PVR without evidence of UTI, renal insufficiency, or bothersome symptoms127 Practice Tip There is no demonstrable correlation between PVR and UTIs in men with BPH.126 Many patients maintain a fairly large PVR without evidence of UTI, renal insufficiency, or bothersome symptoms.127 126. Jepsen JV, Bruskewitz RC. Office evaluation of men with lower urinary tract symptoms. Urol Clinics N Am. 1998;25:550. 127. AUA Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol. 2003;170:533. 126. Jepsen JV, Bruskewitz RC. Urol Clinics N Am. 1998;25:550. 127. 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 Understanding BPH: From the Science to the Clinical Setting

84 2.5 Symptom Assessment Tools
Module 2: Diagnosis of BPH 2.5 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 2.5 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 Understanding BPH: From the Science to the Clinical Setting

85 IPSS and AUA Symptom Score and Disease-Specific QoL Questionnaire
Module 2: Diagnosis of BPH 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 128 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.128 128. AUA Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol. 2003;170: 128 AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170: IPSS = International Prostate Symptom Score; AUA = American Urological Association Understanding BPH: From the Science to the Clinical Setting

86 Questionnaire: International Prostate Symptom Score (IPSS)
Module 2: Diagnosis of BPH Questionnaire: International Prostate Symptom Score (IPSS) Patient Name DOB: ID: Date Of Assessment Initial Assessment ( ) Monitor During Therapy ( ) After Therapy ( ) / Surgery ( ) 5 4 3 2 1 2. Over the past month, how often have you had to urinate again less than two hours after you finished urinating? 1. 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 Questionnaire: International Prostate Symptom Score (IPSS) Patients should self-administer these questionnaires to eliminate the possibility of interviewer bias. In the IPSS and AUA Symptom Index, the patient rates his answers on a progressive scale from one to five, ranging from not at all (0) to almost always (5). The total score indicates the severity of lower urinary tract symptoms (LUTS). Answers may range from 0 (asymptomatic) to 35 (severely symptomatic).129,130 Total IPSS/AUA symptom score: Mild ≤7 Moderate 8–19 Severe ≥20 129. AUA Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol. 2003;170: 130. Cockett ATK et al (eds.). Consensus recommendations. In: The International Consultation on BPH. Paris: SCI Understanding BPH: From the Science to the Clinical Setting

87 Module 2: Diagnosis of BPH
IPSS Cont’d Not at all Less than 1 time in 5 Less than half the time About half the time More than half the time Almost always Total 3. Over the past month, how often have you found you stopped and started again several times when you urinated? 1 2 3 4 5 4. Over the past month, how often have you found it difficult to postpone urinating? 5. Over the past month, how often have you had a weak urinary stream? 6. Over the past month, how often have you had to push or strain to begin urinating? 1 2 3 4 5 None 1 time 2 times 3 times 4 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? Questionnaire: International Prostate Symptom Score (IPSS) Cockett ATK et al (eds.). Consensus recommendations. In: The International Consultation on BPH. Paris: SCI Total I-PSS Score S = Cockett ATK et al (eds.). Consensus recommendations. In: The International Consultation on BPH. Paris: SCI Understanding BPH: From the Science to the Clinical Setting

88 Module 2: Diagnosis of BPH
Questionnaire: Quality of Life (QoL) Quality of Life due to Urinary Symptoms Delighted Pleased Mostly satisfied Mixed about equally satisfied and dissatisfied Mostly dissatisfied Unhappy Terrible 1. 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? 1 2 3 4 5 6 Questionnaire: Quality of Life (QoL) Cockett ATK et al (eds.). Consensus recommendations. In: The International Consultation on BPH. Paris: SCI It is important when we use the AUA or IPSS to use the Quality of Life (QoL) question. The patient rates his answer to the disease-specific QoL question on a progressive scale of 0-6 (delighted to terrible). This question is often referred to as the bother score. Cockett ATK et al (eds.). Consensus recommendations. In: The International Consultation on BPH. Paris: SCI Understanding BPH: From the Science to the Clinical Setting

89 Module 2: Diagnosis of BPH
Voiding Diary Voiding diaries are particularly useful when nocturia is the predominant symptom of LUTS131,132 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 men133,134 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.133,134 131. Chatelain C, Denis L, Foo JKT, Khoury J, et al. Benign Prostatic Hyperplasia. 5th international consultation on BPH. Recommendations of the International Scientific Committee: Evaluation and treatment of lower urinary tract symptoms (LUTS) in older men. Plymouth, UK: Health Publication, 2001:523. 132. AUA Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol. 2003;170:532. 133. Chatelain C, Denis L, Foo JKT, Khoury J, et al. Benign Prostatic Hyperplasia. 5th international consultation on BPH. Recommendations of the International Scientific Committee: Evaluation and treatment of lower urinary tract symptoms (LUTS) in older men. Plymouth, UK: Health Publication, 2001:523. 134. AUA Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol. 2003;170:532. 131. Chatelain C et al. Plymouth, UK: Health Publication, 2001:523. 132. AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170:532. 133. Chatelain C et al. Plymouth, UK: Health Publication, 2001:523. 134. AUA guideline on management of benign prostatic hyperplasia (2003). J Urol. 2003;170:532. LUTS = Lower Urinary Tract Symptoms Understanding BPH: From the Science to the Clinical Setting

90 Module 2: Diagnosis of BPH
Sample Voiding Diary Sample Voiding Diary Adapted from Chatelain C, Denis L, Foo JKT, Khoury J, et al. Benign Prostatic Hyperplasia. 5th international consultation on BPH. Recommendations of the International Scientific Committee: Evaluation and treatment of lower urinary tract symptoms (LUTS) in older men. Plymouth, UK: Health Publication, 2001:523. Adapted from Chatelain C et al. Plymouth, UK: Health Publication, 2001:523 Understanding BPH: From the Science to the Clinical Setting

91 Sexual Function Questionnaire
Module 2: Diagnosis of BPH 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 problem135 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.135 135. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. Fifth edition. Oxford: Health Press, 2005, p21. 135. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p21. LUTS = Lower Urinary Tract Symptoms; BPH = Benign Prostatic Hyperplasia Understanding BPH: From the Science to the Clinical Setting

92 Figure 2.12: Erectile Dysfunction (ED) is Associated with LUTS and BPH
Module 2: Diagnosis of BPH 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% Figure 2.12: Erectile Dysfunction (ED) is Associated with LUTS and BPH Braun M et al., Int J Impot Res 2000; 12: If we look at this figure, we see different factors that have been associated with erectile dysfunction, particularly LUTS and BPH. Braun M et al. Int J Impot Res 2000; 12: ; LUTS = Lower Urinary Tract Symptoms; BPH = Benign Prostatic Hyperplasia Understanding BPH: From the Science to the Clinical Setting

93 Figure 2.13: Impact of Medical Treatment for BPH on Sexual Function
Module 2: Diagnosis of BPH Figure 2.13: Impact of Medical Treatment for BPH on Sexual Function 2 4 6 8 10 12 14 16 18 % Patients Terazosin Alfuzosin Doxazosin Finasteride Tamsulosin Treatment Ejaculation Disorders Erectile Dysfunction Figure 2.13: Impact of Medical Treatment for BPH on Sexual Function Altwein J. XVIIth EAU Congress, Bimingham UK, Feb 2002, Sanofi-Synthelabo satellite. Almost all medical treatment of BPH have an impact on sexual function. Altwein J. XVIIth EAU Congress, Bimingham UK, Feb 2002, Sanofi-Synthelabo satellite. Understanding BPH: From the Science to the Clinical Setting

94 Sample Questionnaire: INTERNATIONAL INDEX OF ERECTILE FUNCTION (IIEF)
Module 2: Diagnosis of BPH 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? 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 Sample Questionnaire: INTERNATIONAL INDEX OF ERECTILE FUNCTION (IIEF) Adapted from Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology Jun;49(6): The International Index of Erectile Function is a questionnaire that has been designed to assess baseline sexual function, treatment choices, and the impact of treatment on sexual function.136 This questionnaire includes 14 questions on different aspects of sexuality. 136. AUA Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol. 2003;170:532-3. 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 Understanding BPH: From the Science to the Clinical Setting

95 Module 2: Diagnosis of BPH
IIEF Cont’d 3. When you attempted sexual intercourse, how often were you able to penetrate (enter) 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 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 5. During sexual intercourse, how difficult was it to maintain your erection to completion of intercourse? INTERNATIONAL INDEX OF ERECTILE FUNCTION (IIEF) Cont’d 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 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 Understanding BPH: From the Science to the Clinical Setting

96 Module 2: Diagnosis of BPH
IIEF Cont’d 7. How much have you enjoyed 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 8. When you had sexual stimulation or intercourse, how often did you ejaculate? 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 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 INTERNATIONAL INDEX OF ERECTILE FUNCTION (IIEF) Cont’d 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 Understanding BPH: From the Science to the Clinical Setting

97 Module 2: Diagnosis of BPH
IIEF Cont’d 11. How would you rate your level of sexual desire? 12. How satisfied have you been with your overall sex life? Very high High Moderate Low Very low – none at all Very satisfied Moderately 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? INTERNATIONAL INDEX OF ERECTILE FUNCTION (IIEF) Cont’d Adapted from Rosen RC et al. Urology Jun;49(6): Understanding BPH: From the Science to the Clinical Setting

98 2.6 Differential Diagnosis of BPH
Module 2: Diagnosis of BPH 2.6 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. 2.6 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. 137. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th edition. Oxford: Health Press, 2005, p21. 137. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p21. Understanding BPH: From the Science to the Clinical Setting

99 Concomitant Medical Conditions
Module 2: Diagnosis of BPH Concomitant Medical Conditions The following medical conditions must be excluded before the patient can be diagnosed with BPH:138 Neurological conditions Inflammatory disorders Neoplastic disorders Causes of polyuria Other causes of obstruction Concomitant Medical Conditions The following medical conditions must be excluded before the patient can be diagnosed with BPH:138 Neurological conditions Inflammatory disorders Neoplastic disorders Causes of polyuria Other causes of obstruction 138. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. Fifth edition. Oxford: Health Press, 2005, p21. 138. Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. 5th ed. Oxford: Health Press, 2005, p21. Understanding BPH: From the Science to the Clinical Setting

100 Module 2: Diagnosis of BPH
2. Inflammatory Disorders140 Urinary tract infection Bladder stones Interstitial cystitis Tuberculous cystitis Neurological Conditions139 Parkinson’s disease Cerebrovascular trauma Shy-Drager syndrome Multiple sclerosis Cerebral atrophy 1. Neurological Conditions139 Parkinson’s disease Cerebrovascular trauma Shy-Drager syndrome Multiple sclerosis Cerebral atrophy 2. Inflammatory Disorders140 Urinary tract infection Bladder stones Interstitial cystitis Tuberculous cystitis 139. Kirby RS. The prostate: small gland, big problem. Abingdon, UK: Prostate Research Campaign UK, 2000, p8, 140. Kirby RS. The prostate: small gland, big problem. Abingdon, UK: Prostate Research Campaign UK, 2000, p8, 139. Kirby RS. Abingdon, UK: Prostate Research Campaign UK, 2000, p8, 140. Kirby RS. Abingdon, UK: Prostate Research Campaign UK, 2000, p8, Understanding BPH: From the Science to the Clinical Setting

101 Module 2: Diagnosis of BPH
Neoplastic Disorders141 Prostate cancer Bladder cancer Causes of Polyuria142 Diabetes Congestive heart failure Excessive fluid intake 3. Neoplastic Disorders141 Prostate cancer Bladder cancer 4. Causes of Polyuria142 Diabetes Congestive heart failure Excessive fluid intake 141. Kirby RS. The prostate: small gland, big problem. Abingdon, UK: Prostate Research Campaign UK, 2000, p8, 142. Kirby RS. The prostate: small gland, big problem. Abingdon, UK: Prostate Research Campaign UK, 2000, p8, 141. Kirby RS. Abingdon, UK: Prostate Research Campaign UK, 2000, p8, 142. Kirby RS. Abingdon, UK: Prostate Research Campaign UK, 2000, p8, Understanding BPH: From the Science to the Clinical Setting

102 Module 2: Diagnosis of BPH
Other Causes of Obstruction Bladder neck dyssynergia External sphincter dyssynergia Urethral stricture Severe phimosis 5. Other Causes of Obstruction Bladder neck dyssynergia External sphincter dyssynergia Urethral stricture Severe phimosis Understanding BPH: From the Science to the Clinical Setting

103 Figure 2.14: Differential Diagnosis
Module 2: Diagnosis of BPH Figure 2.14: Differential Diagnosis Cystitis Medications Anticholinergics Antidepressants Decongestants Bladder Dysfunction (Diabetes) Extrinsic Pelvic Mass Bladder Cancer Cystolithiasis Hypertrophy or Stenosis of Bladder Neck BPH Prostate Cancer Figure 2.14: Differential Diagnosis Adapted from Ouslander JG. Am J Med Sci 1997;314(4):214-8; Kasraeian A. This figure illustrates the location of different pathologies that may mimic BPH. Vesicosphincter dyssynergia Urethral Stricture Urethral carcinoma Urethritis Stenosis of urinary meatus Phimosis Adapted from Ouslander JG. Am J Med Sci 1997;314(4):214-8; Kasraeian A. Understanding BPH: From the Science to the Clinical Setting

104 Module 2: Diagnosis of BPH
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 cancer143 During the early stages of cancer, PSA leaks from cancerous prostate tissue into the blood, where elevated levels can be detected. Prostate Cancer The differentiation of BPH and prostate cancer is a critical issue for primary-care physicians and urologists. The digital rectal examination (DRE) gives the first clues that differentiate BPH from prostate cancer.143 During the early stages of cancer, prostate-specific antigen (PSA) leaks from cancerous prostate tissue into the blood, where elevated levels can be detected. 143. Kirby RS. The prostate: small gland, big problem. Abingdon, UK: Prostate Research Campaign UK, 2000, p8, 143. 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 Understanding BPH: From the Science to the Clinical Setting

105 Module 2: Diagnosis of BPH
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/mL144 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.144 144. National Comprehensive Cancer Network. Prostate Cancer Early Detection. Clinical Practice Guidelines in Oncology. Version , pPROSD-1,2,4,5; MS-4-6. 144. 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 Understanding BPH: From the Science to the Clinical Setting

106 Module 2: Diagnosis of BPH
PSA Velocity145 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 velocity146 PSA Velocity145 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.146 145. National Comprehensive Cancer Network. Prostate Cancer Early Detection. Clinical Practice Guidelines in Oncology. Version , pPROSD-1,2,4,5; MS-4-6. 146. National Comprehensive Cancer Network. Prostate Cancer Early Detection. Clinical Practice Guidelines in Oncology. Version , pPROSD-1,2,4,5; MS-4-6. 145. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version , pPROSD-1,2,4,5; MS-4-6. 146. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version , pPROSD-1,2,4,5; MS-4-6. PSA = Prostate-Specific Antigen Understanding BPH: From the Science to the Clinical Setting

107 Module 2: Diagnosis of BPH
Free PSA147 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. Free PSA147 The U.S. Food and Drug Administration (FDA) has recently approved the use of free PSA (fPSA) in men with total serum PSA of between 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. 147. National Comprehensive Cancer Network. Prostate Cancer Early Detection. Clinical Practice Guidelines in Oncology. Version , pPROSD-1,2,4,5; MS-4-6. 147. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version , pPROSD-1,2,4,5; MS FDA = U.S. Food and Drug Administration PSA = Prostate-Specific Antigen Understanding BPH: From the Science to the Clinical Setting

108 Module 2: Diagnosis of BPH
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. 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 of the prostate Note: these are not defined percentages and various laboratories have different values. Understanding BPH: From the Science to the Clinical Setting

109 Module 2: Diagnosis of BPH
Complexed PSA148 This test measures the form of PSA that is complexed with α1- 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 Complexed PSA148 This test measures the form of PSA that is complexed with a1-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. Prostate Cancer Early Detection. Clinical Practice Guidelines in Oncology. Version , pPROSD-1,2,4,5; MS-4-6. 148. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version , pPROSD-1,2,4,5; MS-4-6. Understanding BPH: From the Science to the Clinical Setting

110 Module 2: Diagnosis of BPH
Practice Tips Elevated PSA and abnormal DRE suggest that the LUTS may be secondary to prostate cancer. 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 Understanding BPH: From the Science to the Clinical Setting

111 Module 2: Diagnosis of BPH
Table 2.9 : PSA Findings PSA Level (ng/mL) Interpretation <4 Normal, unless rising by >25% (0.75ng/mL) per year 4 - 10 20-25% risk of cancer >10 >50% risk of cancer (indication for biopsy) Rise of >0.75ng/mL per year Refer to urologist for urgent assessment Table 2.9: PSA Findings Adapted from Kirby RS, McConnell JD. Benign Prostatic Hyperplasia. Fifth edition. Oxford: Health Press, 2005, p27. On this table we see the usual interpretation of PSA findings: PSA level <4 - Normal, unless rising by >25% (0.75ng/mL) per year PSA level between 4 and % risk of cancer PSA level >10 - >50% risk of cancer (indication for biopsy) Rise of >0.75ng/mL per year - Refer 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 Understanding BPH: From the Science to the Clinical Setting

112 2.7 Indications for Referral to Urologist
Module 2: Diagnosis of BPH 2.7 Indications for Referral to Urologist These findings indicate the need for primary-care physicians to refer the patient to an urologist for further evaluation:149 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 2.7 Indications for Referral to Urologist These findings indicate the need for primary-care physicians to refer the patient to an urologist for further evaluation:149 Any symptoms that need further investigation Suspicion of cancer on DRE Abnormal PSA Hydronephrosis with or without elevated serum creatinine Chronic or recurrent urinary retention Chronic or recurrent urinary tract infection Elevated Residual (≥ 200 ml) Gross hematuria Microscopic hematuria (≥ 3 RBC per high power field (hpf) in 2 out of 3 different urine samples) Failure of medical therapy Patient requests surgical or minimally invasive treatment 149. Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physician’s guide. Mississauga, ON: Astra Pharma Inc., 1996, p19. 149. Ramsey EW, McSherry J. A community care program on benign prostatic hyperplasia: a primary-care physician’s guide. Mississauga, ON: Astra Pharma Inc., 1996, p19. Understanding BPH: From the Science to the Clinical Setting

113 Module 2: Diagnosis of BPH
2.8 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 practice150 (please refer to Module 4) 2.8 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 (Please refer to Module 4).150 150. Nickel JC, Herschorn S, Corcos J, Donnelly B, Elhilali M, et al. Canadian Guidelines for the Management of Benign Prostatic Hyperplasia. Can J Urol. 2005;12: 150. Nickel JC et al. Canadian Guidelines for the Management of Benign Prostatic Hyperplasia. Can J Urol. 2005;12: Understanding BPH: From the Science to the Clinical Setting

114 Module 2: Diagnosis of BPH
2.9 Quiz The normal prostate is about the size of a: Pea Marble Golf ball (Correct) Tennis ball 2.9 Quiz 1. The normal prostate is about the size of a: Pea Marble Golf ball (Correct) Tennis ball Understanding BPH: From the Science to the Clinical Setting

115 Module 2: Diagnosis of BPH
Hardening of the prostate on the DRE suggests: Prostate cancer (Correct) Bladder cancer BOO BPH 2.9 Quiz 2. Hardening of the prostate on the DRE suggests: Prostate cancer (Correct) Bladder cancer BOO BPH BOO = Bladder Outlet Obstruction; BPH = Benign Prostatic Hyperplasia Understanding BPH: From the Science to the Clinical Setting

116 Module 2: Diagnosis of BPH
Which of the following diagnostic tests is recommended by Canadian clinical practice guidelines in the routine evaluation of BPH? Urine cytology TRUS PSA (Correct) Serum creatinine 2.9 Quiz 3. Which of the following diagnostic tests is recommended by Canadian clinical practice guidelines in the routine evaluation of BPH? Urine cytology TRUS PSA (Correct) Serum creatinine BPH = Benign Prostatic Hyperplasia; TRUS = Transurethral Ultrasound; PSA = Prostate-Specific Antigen Understanding BPH: From the Science to the Clinical Setting

117 Module 2: Diagnosis of BPH
PSA measurement is a useful surrogate estimate of prostate volume, because serum PSA levels increase on average by: 0.1 ng/mL per gram of BPH tissue 0.3 ng/mL per gram of BPH tissue (Correct) 0.7 ng/mL per gram of BPH tissue 1.0 ng/mL per gram of BPH tissue 2.9 Quiz 4. PSA measurement is a useful surrogate estimate of prostate volume, because serum PSA levels increase on average by: 0.1 ng/mL per gram of BPH tissue 0.3 ng/mL per gram of BPH tissue (Correct) 0.7 ng/mL per gram of BPH tissue 1.0 ng/mL per gram of BPH tissue PSA = Prostate-Specific Antigen; BPH = Benign Prostatic Hyperplasia Understanding BPH: From the Science to the Clinical Setting

118 Module 2: Diagnosis of BPH
Recent evidence indicates that cancer may occur in 22–24.5% of men with a serum PSA level of: 0.3 ng/mL 2.5 ng/mL (Correct) >4 ng/mL 10 ng/mL 2.9 Quiz 5. Recent evidence indicates that cancer may occur in 22–24.5% of men with a serum PSA level of: 0.3 ng/mL 2.5 ng/mL (Correct) >4 ng/mL 10 ng/mL PSA = Prostate-Specific Antigen Understanding BPH: From the Science to the Clinical Setting


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