CPD Zone Update www.chemistanddruggist.co.uk/update UPDATE Module 1638 » This module covers: DECEMBER ● The prevalence of benign prostatic hyperplasia and associated problems Men's health month ● The symptoms and clinical assessment of patients with benign prostatic hyperplasia ● The latest treatment options, both on prescription and over the counter, for benign prostatic hyperplasia ● Red-flag symptoms for prostate cancer ● Alopecia Dec 1 ● BPH Dec 8 ● Case studies Dec 15 Next week we look at erectile dysfunction, gynaecomastia and testicular cancer Benign prostatic hyperplasia Rosemary Blackie Benign prostatic hyperplasia (BPH) is the nonmalignant enlargement of the prostate gland. It is a progressive condition and a common part of ageing, and falls under the umbrella of lower urinary tract symptoms (LUTS), which cover storage, voiding and post-micturition symptoms affecting the lower urinary tract.1 It is not usually harmful and patients are not at increased risk of prostate cancer.2 Around 3.2 million men in the UK3 suffer from BPH and prevalence increases with age, affecting around 40 per cent of men in their 50s and 90 per cent of those in their 90s.1 Around half of those with BPH have some form of sexual problem3 and men of Afro-American origin are more severely affected.1 In adult men the prostate gland surrounds the urethra, is walnut-sized and is situated between the penis and bladder. It produces prostate specific antigen (PSA) which, when mixed with semen from the seminal vesicles at orgasm and ejaculation, causes the gelatinous liquid to become more fluid. The exact cause of prostate enlargement is unknown but it may be due to an increase in levels of dihydrotestosterone (DHT) as men age, which stimulates prostate growth. Another theory is that there is benign abnormal tissue growth of fibrous, muscle and glandular tissue.14 Symptoms Symptoms fall into two main groups: Obstructive symptoms ● poor stream ● hesitancy ● dribbling ● straining ● incomplete or poor emptying. Intermittent stream irritant symptoms ● frequency ● urgency ● feeling a need to pass urine even when having just done so. 14 Chemist+Druggist 08.12.2012 Prostate size does not correspond in a linear fashion with symptoms experienced, so the effect on quality of life (bothersomeness) is assessed using the International Prostate Symptom Score (IPSS), an internationally validated and approved scoring system used as an aid to guide treatment.5 The IPSS questions are shown in table 1 below; an overall symptom score of zero to seven indicates mildly symptomatic BPH; eight to 19 moderately symptomatic; and 20 to 35 severely symptomatic. For diagnosis of BPH, Nice guidelines recommend5 that a medical history is taken and a physical examination carried out, including a digital rectal examination (DRE) to assess the physical state of the prostate gland. Checks should be made to ensure there is no outflow obstruction in the bladder or that symptoms are not due to nerve damage. Blood tests should include a full blood count and urea and electrolytes, and a dipstick test done for signs of infection. The patient should also carry out a urinary frequency volume chart to help ▶ Table 1. International Prostate Symptom Score (IPSS) questions Severity of symptoms: scored zero (best) to five (worst), scored over the past month Nature of symptom Question Score (zero to five) Incomplete emptying How often have you had a sensation of not emptying your bladder completely after you finish urinating? Frequency How often have you had to urinate again less than two hours after you finished urinating? Intermittency How often have you found you stopped and started again several times when you urinated? Urgency How difficult have you found it to postpone urination? Weak stream How often have you had a weak urine stream? Straining How often have you had to push or strain to begin urinating? Nocturia How may times did you typically get up each night to urinate? Quality of life score: If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that? Delighted 0 Mostly dissatisfied 4 Pleased 1 Unhappy 5 Mostly satisfied 2 Terrible 6 Mixed 3 CPD Zone Update assess symptoms,5 and any signs of urinary tract obstruction should be further investigated with imaging.1 A PSA test, which measures blood levels of prostate specific antigen, should only be offered if there are symptoms that suggest bladder outlet obstruction secondary to BPH, an abnormal prostate on DRE or concerns about prostate cancer. Full information about the limitations of the test should be provided. On its own, the test cannot provide a confirmatory diagnosis of either cancer or BPH, as levels increase with age and vary from person to person. Higher than normal reference ranges can indicate prostate cancer, but can also be caused by infection, vigorous exercise, or a recently performed DRE. 'Normal' PSA levels can also be present with cancer and infection while alpha-blockers can reduce PSA levels.6 Other conditions that present with similar symptoms to BPH include prostate cancer, upper urinary tract infection, bladder tumours, stones or other traumas, chronic pelvic pain, detrusor instability, urethral stricture, chronic prostatitis, and interstitial or radiation cystitis. Treatment options Patients without bothersome symptoms or any complications should be offered lifestyle interventions, reassurance and review as necessary.5 Patients with mild or moderate symptoms can be offered active surveillance (watch and wait) or active intervention treatment involving conservative management, drug treatment or surgery. Alpha-blockers such as tamsulosin, alfuzosin and doxazosin selectively block peripheral alpha-1 adrenoceptors to relax the smooth muscle of the bladder and prostate neck, improving urine flow. Symptom improvement is usually felt within a few days, but can take up to six weeks.1 Alpha-blockers are recommended in moderate to severe LUTS5 and the most common side effects are postural-hypotension, drowsiness and headaches. The 5-alpha-reductase inhibitors finasteride and duasteride block the conversion of testosterone to DHT by the enzyme 5-alpha reductase, to reduce prostate size. This improves flow rate and obstructive symptoms but it can take up to six months to see full symptom improvement.7 They are particularly suitable where there is a significantly enlarged prostate8 and have been shown to reduce long-term risk of acute urinary retention and the need for surgery.1 Side effects include impotence, reduced libido, breast tenderness and enlargement, and reduced PSA markers. Condoms should be used if the patient’s partner is pregnant or likely to become pregnant, as these drugs are excreted 16 Chemist+Druggist 08.12.2012 in semen. Women of child-bearing potential should avoid handling crushed or broken tablets or capsules.8 Bothersome moderate to severe LUTS, where the prostate is estimated to be over 30g or PSA greater than 1.4ng/ml,5 can be treated with a combination of alpha-blocker and 5-alphareductase inhibitor. All treatments should be reviewed after four to six weeks, and then every six to 12 months.5 Other treatment options include anticholinergics for over-active bladder and loop diuretics and desmopressin for nocturnal polyuria. Tadalafil has recently been licensed in Europe for the treatment of the signs and symptoms of BPH in adult males, including those with erectile dysfunction, at a dose of 5mg daily.9 It inhibits the enzyme phosphodiesterase type-5, which results in smooth muscle relaxation and increased blood flow.11 It is contraindicated with concurrent nitrates due to a risk of severe hypotension. Where symptoms are very bothersome, or medication does not help or is unsuitable, surgery is an option. Around a quarter of those with enlarged prostate will undergo surgery.1 In addition, there is some evidence that saw palmetto can help in BPH, especially in frequency and nocturia,4 and also a small evidence-base for beta-sitosterol.12 Various lifestyle measures can be undertaken to reduce the impact of BPH on everyday life and should be advised with or without medication. These include anticipating when frequency or urgency could be a problem – on long journeys, for example – and avoiding drinking too much in the previous two to three hours. Double micturition – returning to the toilet a few minutes after urination to try to pass more urine – can help ensure the bladder is fully empty. Caffeine and alcohol can worsen frequency, nocturia and urgency, and so should be stopped or reduced, as should smoking. Patients can also be advised to try to relax when passing urine, use distraction techniques if urgency is a particular problem and avoid drinking in the two to three hours before bed. Bladder retraining, where the patient tries to hold on for as long as possible before passing urine, can also help to expand and strengthen the bladder muscle. Initially, a symptoms questionnaire must be completed by the patient, which includes the IPSS, and the patient must meet all the following conditions: ● Aged between 45 and 75 years ● Has experienced symptoms for more than three months ● Is not currently being treated for BPH. If the patient has either an IPSS symptom score of eight or more, or a symptom score of at least one and a quality of life score of four or more, the patient is eligible for an initial two-week supply. The patient should then be directed to their GP for confirmation of the diagnosis. After two weeks the patient should be reassessed, and a further four-week supply can be sold if symptoms have improved; no further supplies can be made after this sixweek period if the patient has not consulted his GP. Following this, up to 52 weeks can be supplied (in monthly amounts) and the patient reviewed by their GP annually. Flomax should be taken the same time each day after food, and it is important to encourage the patient to continue to take capsules even if he feels much better, as BPH is a progressive condition. Patients with pain on urination, bloody or cloudy urine within the last three months, unexplained fever, urinary incontinence, unstable or undiagnosed diabetes or liver, kidney or heart problems are not suitable for OTC treatment and should be referred to their GP. OTC treatment Further resources Nice guidelines indicate LUTS can initially be assessed and treated, if appropriate, in a nonspecialist setting. Flomax Relief (tamsulosin) was launched in 2010 in an effort to capture those who do not or will not go to the GP for various reasons, including embarrassment and lack of time. ● Flomax website – www. myilearn.co.uk/ flomax ● Flomax Relief support staff training guide – www. myilearn.co.uk/flomax/resources/ documents/Flomax_Relief_Pharmacy_ Support_Staff_Training_Guide.pdf ● Flomax patient support – ▶ Prostate cancer Prostate cancer is the most common male cancer, with around 40,000 cases diagnosed in the UK each year, and the most common cause of cancer-related death in men.3 Symptoms are often non-specific and in line with other LUTS, but haematuria and pain on ejaculation are two of the red-flag symptoms. Risk factors for prostate cancer include: ● increasing age ● family history of breast or prostate cancer ● African ethnicity ● a diet high in saturated fat and red meat with little fruit and vegetables. The PSA test is used to aid diagnosis, together with further investigation, including biopsy. There is no screening programme, but there is an NHS Prostate Cancer Risk Management programme. CPD Zone Update 5 minute test ■ Sign up to take the 5 Minute Test and get your answers marked online: chemistanddruggist.co.uk/update Take the 5 Minute Test 1. Patients who have BPH have an increased risk of prostate cancer. True or false? 2. BPH affects around 3.2 million men in the UK. True or false? 3. Three-quarters of men with BPH also have some form of sexual problem. True or false? 4. A patient with a score of 10 from the IPSS questionnaire would be considered to have severely symptomatic BPH. True or false? 5. A prostate specific antigen test provides confirmation of a diagnosis of BPH. True or false? 6. Side effects of tamsulosin include postural hypotension, drowsiness and headache. True or false? 7. Finasteride acts by relaxing the smooth muscle of the bladder and prostate neck. True or false? www. flomaxrelief.co.uk ● Prostate Action UK – www. prostateaction. org.uk ● NHS Choices – www.nhs.uk/conditions/ Prostate-disease ● NHS Prostate Cancer Risk Management Programme – www. cancerscreening.nhs.uk/ prostate References 1. Patient UK Plus. Benign prostatic hyperplasia. www.patient.co.uk/doctor/benign-prostatichyperplasia 2. Prostate Enlargement. NHS Choices. www.nhs.uk/conditions/prostate-enlargement 3. Prostate Action UK. Benign prostatic hyperplasia (BPH) facts and figures. www. prostateaction.org.uk 4. A. Vogel. Enlarged Prostate Pharmacy herbal handbook 2. 2012 5. Nice. The management of lower urinary tract symptoms in men Clinical Guideline 97. May 2010 6. Clinical Knowledge Summaries. Lower urinary tract symptoms in men, age-related (including symptoms of benign prostatic hyperplasia/hypertrophy). cks.nhs.uk 7. Pfizer. Finasteride summary of product characteristics 2012. 8. British National Formulary. Number 64. September 2012. bnf.org 9. Cialis. Summary of opinion (post authorisation). European Medicines Agency. 18 Chemist+Druggist 08.12.2012 8. Sildenafil is licensed for the treatment of the signs and symptoms of BPH. True or false? 9. OTC tamsulosin is suitable for men aged 40 to 70 years who have experienced symptoms for longer than six months. True or false? 10. Patients started on OTC tamsulosin must see their GP within six week for diagnosis confirmation. True or false? Update 2013 Sign up now and save £5 Sign up for Update 2013 now! Save £5 with our early bird offer and get maximum value from this CPD programme for pharmacists and pharmacy technicians. Go to www. chemistanddruggist.co.uk/update and sign up now for £30+VAT (£36). (Standard price £35+VAT (£42). Offer ends January 31, 2013) September 20, 2012 10. Eli Lilly and Company UK. Cialis (tadalafil) backgrounder (2of 2). November 2012 11. Eli Lilly and Company UK. Cialis summary of product characterisitics 12. Bandolier medicine. Beta-sitosterol for benign prostatic hyperplasia 13. Boehringer Ingleheim. Flomax Relief MR pharmacy support staff training guide. December 2009 14. BPH. General Practice Notebook Tips for your CPD entry on benign prostatic hyperplasia Reflect How are the symptoms of benign prostatic hyperplasia (BPH) assessed? How do 5-alpha-reductase inhibitors work? What criteria must be fulfilled for OTC treatment of BPH with tamsulosin? Plan This article describes the symptoms and diagnosis of BPH and includes information about treatment options such as alpha-blockers and 5-alphareductase inhibitors. Lifestyle advice, prostate cancer and OTC treatment are also discussed. Act Read the article and the suggested reading below, then take the 5 Minute Test (left). Update subscribers can then access their answers and a pre-filled CPD logsheet. Learn more about BPH from NHS Choices. http://tinyurl.com/prostate11 Read the prostate gland enlargement management options brief decision aid on the Patient UK website, which summarises treatment benefits and risks. http://tinyurl.com/prostate12 Revise your knowledge of the OTC supply of tamsulosin with the Flomax Relief training materials. http://tinyurl.com/prostate13 Find out more about prostate cancer from the Cancer Research UK website and the PSA test from the Patient UK website. http://tinyurl.com/prostate14 http://tinyurl.com/prostate15 Read the MUR tips for BPH from C+D. http://tinyurl.com/prostate16 Evaluate Are you now confident in your knowledge of BPH? Could you give advice to patients about treatment options and lifestyle?
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