United Kingdom National guideline for the management of prostatitis (2008)

Clinical Effectiveness Group British Association of Sexual Health and HIV Introduction and Methodology Scope and Purpose: This guideline offers recommendations on the management of acute and chronic prostatitis in the setting of genitourinary medicine clinics. It applies primarily to men aged 18 years or older presenting to health care professionals, working in departments offering level 3 care in Sexual Health (see national strategy) within the United Kingdom. However, the recommendations should prove useful in other settings such as urology and primary care. Stakeholder involvement: The authors are clinicians working in this field. Members of BASHH have had the opportunity to comment on the guideline, prior to publication. Rigour of Development: Search Strategy Medline Search 1996-2006 using keyword prostatitis pelvic pain, male and chronic pelvic pain, male. Cochrane Database of Systematic reviews and the Cochrane Controlled Trials Register up 2007 using keyword prostatitis. Additional studies and review articles were identified through a manual search of bibliographies of retrieved articles Inclusion/exclusion of evidence criteria: Where available systematic reviews were used. Studies were limited to humans and English language. The previous guidelines (published in 2000) were used as a framework that was revised and updated. Classification Prostatitis is classified into the following categories as recommended by the US National Institutes for Health (NIH) [1] I II III Acute bacterial prostatitis Chronic bacterial prostatitis Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) A Inflammatory B Non-inflammatory (This division, based on the four-glass test, has not been shown to be of any clinical or prognostic significance ([2]) Asymptomatic inflammatory prostatitis

IV

(This is a histological diagnosis in patients undergoing a prostate biopsy and is not discussed further in these guidelines.) Acute and chronic bacterial prostatitis account for <5% of all prostatitis diagnoses; their precise incidence is unknown. Acute Prostatitis Aetiology Acute prostatitis is caused by urinary tract pathogens [3]. These include: Gram negative organisms, most commonly Escherichia coli, Proteus spp, Klebsiella spp and Pseudomonas spp Enterococci Staphylococcus aureus due to prolonged catheterisation Rarely anaerobes such as Bacteroides spp Mode of Transmission Infection may spread from the distal urethra/urethral meatus but can also spread from the bladder, blood and lymphatic system. Acute prostatitis is an uncommon complication of UTI. Clinical features Symptoms [4,5,6] Acute prostatitis is an acute severe systemic illness. Symptoms include: symptoms of a urinary tract infection: dysuria, frequency and urgency symptoms of prostatitis: low back pain, perineal, penile and sometimes rectal pain symptoms of bacteraemia: fever and rigors; arthralgia and myalgia may occur Signs [4,5,6] Signs include: signs localised to the prostate: an extremely tender, swollen and tense, smooth textured prostate gland which is warm to the touch signs of the bacteraemia: pyrexia and tachycardia Complications Patients with acute prostatitis may present with acute retention secondary to prostatic oedema Prostatic abscess, bacteraemia, epididymitis and pyelonephritis.

Diagnosis Mid-stream urine sample for dipstick testing, culture for bacteria and antibiotic sensitivity Blood cultures for bacteria and antibiotic sensitivity Prostatic massage should not be performed on patients with acute bacterial prostatitis. This may be painful, can precipitate bacteraemia, and is likely to be of little benefit as pathogens are almost always isolated from urine.

Management General Advice Adequate hydration should be maintained, rest encouraged and analgesics such as non-steroidal anti-inflammatory drugs if required Treatment As acute prostatitis is a serious and severe illness empirical therapy should be started immediately after blood and urine cultures have been obtained. Parenteral or oral treatment should be selected according to the clinical condition of the patient. If there is deterioration or failure to respond to oral therapy urgent admission and parenteral therapy should be arranged. Good antibiotic penetration into all areas of the prostate gland is achieved because of the intense inflammation. Antibiotics should be continued or changed according to sensitivity results. If acute retention occurs suprapubic catheterisation should be performed to avoid damage to the swollen prostate [6].

Recommended Regimens For patients requiring parenteral therapy antibiotics covering the likely organisms should be used [7]. A high dose broad spectrum cephalosporin (for example, cefuroxime, cefotaxime or Ceftriaxone) plus gentamicin (level of evidence IV, grade of recommendation C) When clinically improved the therapy can be switched to oral treatment according to sensitivities. For patients suitable for oral therapy, quinolones can be used [8,9]: Ciprofloxacin 500mg twice daily for 28 days (IV, C) [9] or Ofloxacin 200mg twice daily for 28 days (IV, C) [10,11].

Allergy For patients intolerant of, or allergic to, quinolones an alternative is: Trimethoprim 200mg twice daily for 28 days (IV, C). Sexual partners Treatment of sexual partners is not required. Follow-up If the patient fails to respond fully to therapy the diagnosis of a prostatic abscess should be considered [12]. This can be confirmed by transrectal ultrasound scan or computed tomography scan of the prostate. If present, perineal or transurethral drainage is necessary [6]. If acute prostatitis is managed correctly the prognosis is good. The optimal duration of treatment is not known. 4 weeks of antibiotic therapy is usually recommended to reduce the risk of developing chronic bacterial prostatitis [4]. Following recovery, the urinary tract should be investigated to exclude a structural cause for urinary tract infection. Chronic Bacterial Prostatitis (CBP) This is chronic bacterial infection of the prostate with or without symptoms of prostatitis, and with a history of recurrent urinary tract infections caused by the same bacterial strain without any structural abnormalities. It is rare in comparison to CP/CPPS. Aetiology The usual causative bacteria are those causing urinary tract infection, most commonly E coli [13]. Some Gram positive organisms such as Staphylococcus aureus and Enterococcus faecalis may cause CBP [14,15]. The role of other Gram positive organisms such as coagulase negative staphylococci , non-group D streptococci and diptheroids remains controversial and subject to debate [16]. Clinical Features Symptoms Typically there is a history of recurrent or relapsing urinary tract infection, urethritis or epididymitis. Patients frequently report genitourinary and pelvic pain / discomfort during a flare-up and alleviation of symptoms after antibiotic treatment. They may be asymptomatic between acute episodes or have mild pelvic pain or irritative voiding symptoms (frequency, urgency). Signs

Apyrexial, no systemic signs. The patient may have a diffusely tender prostate during acute episodes otherwise no objective clinical signs. Diagnosis This is usually based on history of recurrent urinary tract infections by the same bacterial strain and the exclusion of other causes. In particular, no structural reason for recurrent urinary tract infection is identified on urinary tract imaging. Investigations 1. Urine dipstick test (for evidence of urinary tract infection or other abnormality that may require investigation e.g. haematuria). 2. MSU - urine cultures are sterile unless an acute urinary tract infection is present - review past MSU results. 3. Urinary tract imaging (ultrasound or IVU) to exclude structural abnormalities. 4. Lower urinary tract localisation study or four-glass test (see appendix 1 for details of this). The reliability of this test is not known because a gold standard for the diagnosis is not available. The four-glass test is not widely used in clinical practice and may not alter patient management [17]. Nonetheless, in suspected CBP it may be considered and can confirm the diagnosis. 5. Urodynamics may be considered, to exclude other conditions predisposing to recurrent UTI. Management General advice Patients should be given a detailed explanation of their condition that the prostate is a focus of infection which causes recurrent urinary tract infection with particular emphasis on the long-term implications for their health and the possibility of further episodes of urinary tract infection unless the focus is eradicated by successful treatment. Clear and accurate written information can help to reinforce this. Treatment Antibiotic treatment should be chosen according to bacterial cultures and sensitivities. Fluoroquinolones have become standard of care in CBP (Ib, A) they have good penetration of the prostate gland and broad spectrum activity against both gram-negative and gram-positive organisms [18,19,20]. Most comparative studies have shown similar rates of clinical success and/or bacteriological cure for the fluoroquinolones [20]. The recommendations for other antibiotics are based on small studies plus expert opinion.

Recommended regimens For patients with CBP first-line treatment is with a quinolone such as [20] Ciprofloxacin 500mg twice daily for 28 days (Ib, A) [15,21] or Levofloxacin 500mg od for 28 days (Ib,A) [15,22] or Ofloxacin 200mg twice daily for 28 days (III, B) [23.24] or Norfloxacin 400mg twice daily for 28 days (III, B) [25,26] Side effects of quinolones generally well tolerated but tendon damage including rupture has occurred very rarely. Recent FDA recommendations include advising the patient that at the first sign of tendon pain, swelling or inflammation they should stop taking the drug, avoid exercise and use of affected area and contact their doctor [27]. Allergy For those allergic to quinolones or in patients recommended to avoid quinolones (epilepsy or prone to seizures) treatment should be selected according to antibiotic sensitivities of the bacterial isolate, and an antibiotic with good penetration into the prostate should be chosen. There is poor evidence for these alternative antibiotics. Options include: Minocycline 100mg twice daily for 28 days [28] (III, B) (In practice most experts would use doxycycline 100mg twice daily for 28 days because of more toxicity with minocycline.) or Trimethoprim 200mg twice daily for 28 days (IV,B) If minocycline or doxycycline are used antibiotic sensitivity testing is important, as many urinary pathogens are tetracycline resistant. Alpha blockers there is small amount of evidence that adding in alpha blockers to antibiotics may improve symptoms of chronic bacterial prostatitis and relapse rate but the study was difficult to analyse [29]. Some investigators have reported the use of submucosal injections of antibiotics but this approach is not widely used [30]. Follow-up Patients with CBP are at risk of relapse and should have a repeat MSU after completing treatment.

For recurrent UTI after 28 days of treatment, further investigation for predisposing conditions should be considered, antibiotic sensitivities should be rechecked and the treatment repeated. Prolonged courses of antibiotic (e.g. 3 months) may be tried but have not been studied systematically. Prostatic calculi have been suggested as a source for recurrent infection [6]. They are very common radiographically [31,32]. Radical transurethral prostatectomy or total prostatectomy have been reported to be effective in a small number of patients if they are selected carefully and for very specific indications, but usually this is not justified [33,34 ]. Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) Introduction This is a common chronic condition with estimates of between 2 and 14% lifetime prevalence [35,36,37,38]. It cannot be rigidly defined but a suggested definition is the presence of typical symptoms of discomfort or pain in the genital or pelvic region for more than 3 months within the past 6 months [39]. Aetiology Unknown aetiology, may be multifactorial. Proposed mechanisms include: Infection (there is no evidence that CPPS is caused by an STI) [13,40,41] Immunological [42,43,44,45,46] Autoimmunity [47,48] Neuromuscular spasm/pelvic floor muscle dysfunction [49,50] Intraprostatic urine reflux [51,52,53,54] Voiding dysfunction leading to increased intraprostatic pressure [54] Neurogenic inflammation [55] Functional somatic syndrome [56,57] Chronic pain syndrome [58,59] Clinical features Symptoms Urological pain [1] including perineal pain lower abdominal pain penile pain (especially penile tip) testicular pain

 rectal and lower back pain ejaculatory pain Patients also complain of variable irritative and obstructive symptoms and/or ejaculatory disturbance [60]. The constellation of symptoms appear to be relatively similar and consistent in men with CP/CPPS [61]. The symptoms usually remain constant although some men have large fluctuations in the severity of symptoms over time [61]. Strictly, symptoms should have been present for at least 3 months to diagnose CPPS [1] although in practice the diagnosis is often suspected after a shorter duration of symptoms (see definition above). There are several exclusion criteria for the diagnosis Active urethritis, urogenital cancer, urinary tract disease, functionally significant urethral stricture or neurological disease affecting the bladder[1]

Assessment of symptoms Symptom inventory or index (NIH CPSI) (see appendix 2) This is a validated symptom questionnaire that scores on pain, voiding dysfunction and quality of life [62]. It should not be used to diagnose CP/CPPS but may be useful as an evaluative tool to assess current symptoms and their impact. It is also useful in assessing changes in symptom severity and impact during follow up, and as an outcome measure following treatment [63]. Signs There are few objective clinical signs and the prostate gland may, or may not, be locally or diffusely tender to palpation. Complications Significant physical and psychological impact cross-sectional studies have shown sickness impact scores comparable to those with angina and Crohns disease [64] and mental health scores worse than the most severe subgroups of diabetes mellitus and chronic heart failure [65]. Diagnosis There is no gold standard diagnostic test for this condition, therefore CP/CPPS is a diagnosis of exclusion [66]. Diagnosis is usually made on a typical history and not on examination or investigation findings.

The initial diagnostic evaluation of a patient presenting with pelvic pain should consider the possibility of other underlying disease or disorder that could cause the symptoms [67]. Atypical presentations may require investigation to exclude other conditions before the diagnosis is made. Initial screening should involve taking a complete history, examination including digital rectal examination, urinalysis and MSU microscopy and culture [66,67,68].

Test no longer recommended: Lower urinary tract localisation study (four-glass test) (see appendix 1 for details of this) Recent studies have reported that localising leucocytes/bacteria to the prostate cannot accurately differentiate between men with CP/CPPS and men without symptoms [2] and results of the test do not correlate with duration, frequency and severity of symptoms [69]. The test procedure has not been standardised [70]. Some argue that the test should be confined to research. It is not widely used in clinical practice [17,71] and may not alter patient management [72]. Therefore the test cannot be recommended in the routine investigation of CP/CPPS. Further tests that may be considered: STI screen Non-specific urethritis (NSU), chlamydia and gonorrhoea should be excluded. In selected patients: Urine cytology if the patient has microscopic haematuria with frequency, urgency and dysuria urine cytology should be performed to help exclude lower urinary tract malignancy [73]. Patients with unexplained haematuria should be referred to an urologist. PSA PSA is recommended if indicated by abnormal prostate on digital rectal examination [74]. Prostatic tenderness is not an indication. PSA can be elevated during active inflammation of the prostate [75].

Simple urodynamics [76] may identify bladder neck dysfunction, bladder outflow obstruction and incomplete bladder emptying particularly in those with urinary symptoms. Transrectal ultrasound (TRUS) is not useful in differentiating the various forms of chronic prostatitis [77]. TRUS may identify prostatic calcification but the significance of this is uncertain. Anecdotal reports indicate that TRUS may rarely identify a treatable prostatic abscess or cyst, seminal vesicle or ejaculatory duct abnormality [78](which may present with ejaculatory pain), but its routine use in the investigation of suspected CP/CPPS is not justified. Patients with atypical presentations of CP/CPPS and unexplained urological symptoms should be referred to a urologist.

Management General advice Patients should be given a detailed explanation of their condition with reassurance, indicating that CP/CPPS is a non-malignant condition and not a sexually transmitted infection that has a tendency to persist [79]. The cause has not been determined with certainty but infection is unlikely. Diagrams and written information (a leaflet) may be helpful. (further information can be obtained from www.prostatitis.org) Treatment There are no reliably effective treatments for CP/CPPS [66,80,81]. Few randomised, controlled trials are available and no large scale, welldesigned trials have been conducted. An observational report from a specialised prostatitis clinic reported reasonable clinical results in only one third of patients with monotherapy [82]. This may not reflect the prognosis in newly diagnosed patients. Multimodal therapy (i.e. using multiple treatment types simultaneously) has therefore been proposed but this is not based on evidence from randomised trials [83]. Treatment should be individualised as CP/CPPS is not a standardised disease or specific inflammatory process but rather a clinical syndrome. Antibiotics (III,C) There is no convincing evidence that antibiotics are effective in CP/CPPS. Many clinicians try antibiotics initially, as there is evidence that some patients benefit in uncontrolled clinical studies [84]. The effects of antibiotics could be a placebo effect as there appears to be a large placebo effect in most RCTs in this condition [85,86,87] or related to anti-inflammatory properties of some antibiotics such as doxycycline

and fluoroquinolones [88,89]; or antibiotics may eradicate bacteria that are not routinely cultured or culturable. Two recent RCTs have shown no benefit of antibiotics versus placebo but both of these studies were in heavily pretreated patients [83,85]. The value of antibiotic treatment in treatment naive men has not been assessed. The toxicity of antibiotics, particularly prolonged use of fluoroquinolones, must also be considered. There is also concern that use of fluoroquinolones may increase susceptibility to C. difficile infection [90]. Alpha-blockers (Ia,A) There is modest evidence of their efficacy in CP/CPPS and a trial should be considered in patients with troublesome persistent symptoms. A systematic review showed a relative risk of improvement of 0.57 translating as number needed to treat of 6 [80]. The evidence suggests prolonged treatment is needed (14-24 weeks) to show a clinically significant effect and benefits appear greatest in those nave to alphablockers. RCTs where benefit was found included the following drugs and doses: Alfuzosin 5mg bd for 6 months [86]. Alfuzosin modified release 10 mg nocte may be used as an alternative but has not been evaluated; Tamsulosin 0.4mg for 6 weeks [91,92] Terazosin 1mg for 4 days , 2mg for 10 days then 5mg for 12 weeks (14 weeks total) [87], or terazosin 5mg for 8 weeks [93] or terazosin 1-2mg tds for 6 months [94] Doxazosin 4mg daily for 6 months [95] A further RCT [83] found no benefit with tamsulosin 0.4mg for 6 weeks; however patients were highly pretreated and probably not nave to alpha blockers. Side effects of alpha blockers of significance postural hypotension and headache. Other treatments Limited evidence of effectiveness (from at least one RCT) has been reported for the following investigational treatments (in alphabetical order): Finasteride (IbA) [96] Fluoxetine (IbA)[97] Mepartricin (IbA)[98] Pelvic electromagnetic therapy (IbA) [99] Prostat/poltit (pollen extract) (IbA)[100]

Quercetin (IbA) [101] The following investigational treatments are of unknown effectiveness, and cannot be recommended, because reported studies are case series, uncontrolled trials or small RCTs showing no statistical benefit: Aerobic exercise [102] Acupuncture [103] Allopurinol [104] Biofeedback, pelvic floor re-education and bladder training [105,106] Botulinum toxin A [107] Capsaicin [108] Cernilton (pollen extract)[109] Cooled transurethral microwave therapy [110] Corticosteroids [111] Ibuprofen [112] Myofascial trigger point release and paradoxical relaxation training [113] Prostatic massage [114] Pelvic floor physical therapy [115] Pentosan polysulphate [116] Percutaneous tibial nerve stimulation [117] Sacral magnetic stimulation [118] Sertraline [119] Terpene mixture (rowatinex) [112] Transurethral needle ablation (TUNA)[120] Urethroanal stimulation [121] Zafirlukast [122] Tricyclic antidepressants (eg amitriptyline) are sometimes tried in CP/CPPS but there are no published trials to support their use. They have been shown to be effective in some patients with other forms of chronic pain [123]. Sexual partners Partner notification and empirical treatment of sexual partners are not required unless a specific sexually transmitted pathogen is found at initial screening. Management should be according to the guidelines for that specific infection. Follow-up Chronic prostatitis is a difficult to manage, relapsing condition with fluctuating symptoms and patients are typically followed up for long periods of time. No specific follow-up recommendations can be made.

The NIH chronic prostatitis symptom index can be used as an outcome measure following treatment [62]. Prognosis There is no evidence that CP/CPPS patients have a decreased survival over 2 years [61]. Most of men initially diagnosed with CP/CPPS experience symptom improvement over the following 6 months [124] In one study approximately 33% of patients had no further symptoms one year later [125]. In the largest prospective longitudinal evaluation of the natural history of CP/CPPS, one-third of men showed moderate to marked improvement over two years [61]. The prognosis appears to be worse in those with previous episodes, more symptoms, depressive symptoms and ejaculatory pain. [61,124, 125,126]. Qualifying statement The recommendations in this guideline may not be appropriate for use in all clinical situations. Decisions to follow these recommendations must be based on the professional judgement of the clinician and consideration of individual patient circumstances and available resources. All possible care has been undertaken to ensure the publication of the correct dosage of medication and route of administration. However, it remains the responsibility of the prescribing physician to ensure the accuracy and appropriateness of the medication they prescribe. Auditable Outcome Measures Initial assessment of men with suspected CP/CPPS to include documented history, examination including digital rectal examination, urinalysis and MSU microscopy and culture (target 95%). Initial investigation of men (who have been sexually active) with CP/CPPS to include STI screen (target 95%). Acknowledgements Authors and Centre Emma Street, Janet Wilson, Department of Genitourinary Medicine, The General Infirmary at Leeds. Graz Luzzi, Department of Genitourinary Medicine, Wycombe Hospital, High Wycombe. Membership of the CEG Clinical Effectiveness Group: chairman, Keith Radcliffe; Imtyaz AhmedJushuf; David Daniels; Mark Fitzgerald; Neil Lazaro; Gillian McCarthy; Guy Rooney. Editorial Independence This guideline was commissioned and edited by the CEG of the BASHH, without external funding being sought or obtained.

No conflict of interest by any authors or group members.

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63. Turner JA, Ciol MA, Korff MV, Berger R. Validity and responsiveness of National Institutes of Health Chronic Prostatitis Symptom Index. J Urol 2003;169(2):580-583 64. McNaughton Collins M, Pontari MA, OLeary MP, et al. Quality of life is impaired in men with chronic prostatitis; the Chronic Prostatitis Collaborative Research Network. J Gen Intern Med 2001;16(10):656-662. 65. Wenninger K, Heiman JR, Rothman I, Berghuis JP and Berger RE. Sickness impact on chronic nonbacterial prostatitis and its correlates. J Urol 1996;155(3):965-968. 66. McNaughton Collins M, MacDonald R and Wilt TJ. Diagnosis and Treatment of chronic abacterial prostatitis: a systematic review. Ann Intern Med 2000;133:367-381 67. Nickel JC Clinical Evaluation of the patient presenting with prostatitis. Eur Urol 2003. (Suppl) 68;1-4. 68. Nickel JC. Clinical Evaluation of the Man with Chronic Prostatitis/chronic pelvic pain syndrome. Urol 2002;60(suppl 6A):20-23. 69. Schaeffer AJ, Knauss JS, Landis JR, et al. Leukocyte and bacterial counts do not correlate with severity of symptoms in men with chronic prostatitis: the National Institutes of Health chronic prostatitis cohort study. J Urol 2002;168:1048-1053. 70. Muller CH, Berger R, Mohr LE and Kreiger J. Comparison of microscopic methods for detecting inflammation in expressed prostatitis secretions. J Urol 2001;166:2518-2524 71. Luzzi GA, Bignell C, Mendel D and Maw RD. Chronic Prostatitis/Chronic Pelvic Pain Syndrome: a national survey of genitourinary medicine clinics. Int J STD AIDS 2002;13(6):416-419. 72.Thin RN. Diagnosis of chronic prostatitis: overview and update. Int J STD & AIDS 1997;8(8):475-81. 73. Nickel JC, Adern D and Downey J. Cytologic Evaluation if Urine is Important in Evaluation of Chronic Prostatitis. Urology 2002;60(2):225227 74. Referral guidelines for suspected cancer in adults and children: guidelines for suspected urological cancer. Reference CG27. www.nice.org.uk 75. Nadler RB, Schaeffer AJ, Knauss JS, et al. Total Prostate specific Antigen is elevated and statistically, but not clinically significant, in patients with chronic pelvic pain syndrome/ prostatitis (abstract) 2003;J Urol 169(suppl 4):27. 76.Kohn IJ, Te AE, Kaplan SA. The role of urodynamics in evaluating patients with chronic prostatitis. In; Nickel JC (Ed) Textbook of Prostatitis. ISIS Medical Media, Oxford, pp 227-232. 77. Ludwig M, Weidner W, Schroeder-Printzen I, Zimmerman O and Ringert RH. Transrectal prostatic sonography as a useful diagnostic means for patients with chronic prostatitis or prostatodynia. Br J Urol 1994;73(6):664-8. 78. De La Rosette JJ, Karthaus HF, Debruyne FM. Ultrasonographic findings in patients with non-bacterial prostatitis. Urol Int 1992;48:323326.

79. Turner JA, Ciol MA, Von Korff M and Berger R. Health Concerns of patients with nonbacterial prostatitis/pelvic pain. Arch Intern Med 2005;165:1054-1059. 80. Dimitrakov JD, Kaplan SA, Kroenke K, Jackson JL and Freeman MR. Management of Chronic Prostatitis/ Chronic Pelvic Pain Syndrome: An Evidence-Based Approach. Urology 2006;67(5):881-888. 81. Jang T and Schaeffer A. (2005) Chronic prostatitis. Clinical Evidence. Volume 13. www.clinicalevidence.com 82. Nickel JC, Downey J, Ardern D, Clark J and Nickel K. Failure of a monotherapy strategy for difficult chronic prostatitis/chronic pelvic pain syndrome. J Urol 2004;172:551-554. 83. Alexander RB, Propert KJ, Scaheffer AJ, et al. Ciprofloxacin or tamsulosin in men with chronic prostatitis/chronic pelvic pain syndrome: a randomised, double-blind trial. Ann Intern Med 2004;141:581-9. 84. Nickel JC, Downey J, Johnston B and Clark J. Predictors of patient response to antibiotic therapy for chronic prostatitis/chronic pelvic pain syndrome: a prospective mulitcenter clinical study. J Urol 2001;165:1539-1544. 85. Nickel JC, Downey J, Clark J, et al. Levofloxacin for chronic prostatitis/chronic pelvic pain syndrome in men: a randomised placebocontrolled mulitcenter trial. Urology 2003;62:614-617. 86. Mehik A, Alas P, Nickel JC, Sarpola A and Helstrom PJ. Alfuzosin treatment for chronic prostatitis/chronic pelvic pain syndrome: a prospective randomised, double-blind, placebo-controlled, pilot study. Urology 2003;62:425-429. 87. Cheah PY, Liong ML, Yen KH, et al. Terazosin therapy for chronic prostatitis/chronic pelvic pain syndrome: a randomized, placebocontrolled trial. J Urol 2003;169:492-596 88. Dalhoff A, Shalit I. Immunomodulatory effects of quinolones. Lancet Infect Dis 2003;3(6):359-371. 89.Kuzin II, Snyder JE, Uqine GD, et al. Tetracyclines inhibit activated B cell function. Int Immunol 2001;13(7):921-931. 90. Delaney JAC, Dial S, Barkun A and Suissa S.Antimicrobial drugs and community-acquired Clostridium difficle-associated disease, UK. Emerg Infect Dis [serial on the internet] 2007 May [9th September 2008] Available from http://www.cdc.gov/EID/content/13/5/761/htm. 91.Nickel JC, Narayan P, McKay J and Doyle C. Treatment of chronic prostatitis/chronic pelvic pain syndrome with tamsulosin: a randomised double blind trial. J Urol 2004;171:1594-1597. 92.Batstone RD, Lynch J and Doble A. A randomized-placebo controlled pilot study of tamsulosin, naproxen and combination in category IIIA/IIIB chronic prostatitis/chronic pelvic pain syndrome(abstract). J Urol 2005 (suppl 4); 173:30. 93.Sivkov A, Oshepkov V, Egorov A and Pataki K. Terazosin in patients with chronic prostatitis(abstract). BJU Int 2004;94 (suppl 2):5. 94. Cho I, Kim J, Lee K, Lee K and Chang Y. The effect of terazosin on symptom recurrence in men with chronic prostatitis/chronic pelvic pain syndrome(abstract). Urology 2006;68(Suppl 15A):55.

95. Tugcu V, Tasci AI, Fazlioglu A, et al. A Placebo-Controlled Comparison of the efficiency of triple- and monotherapy in category IIIB chronic pelvic pain syndrome (CPPS). Eur Urol 2007:51:1113-1118. 96 Kaplan MA, Volpe MA, Te AE. A prospective 1 year trial using saw palmetto versus finasteride in the treatment of category III prostatitis/chronic pelvic pain syndrome. J Urol 2004;171(1):284-288. 97.Pavlopoulos PM, Xanthopoulou G, Kakouri P, et al. Fluoxetine in the management of men with chronic prostatitis/chronic pelvic pain syndrome (abstract).Urology 2006;68(Suppl 5A):53-54. 98. De Rose, AF, Gallo F, Giglio M and Carmignani G. Role of mepartricin in category III chronic nonbacterial prostatitis/ chronic pelvic pain syndrome: a randomized prospective placebo-controlled trial. Urology 2004;63(1):13-16. 99.Rowe E, Smith C, Laverick L, et al. A prospective randomized, placebo-controlled double-blind study of pelvic electromagnetic therapy for the treatment of chronic pelvic pain syndrome with 1 year of followup. J Urol 2005;173:2044-2047 100. Elist J. Effects of Pollen Extract Preparation Prostat/Poltit on lower urinary tract symptoms in patients with chronic nonbacterial prostatitis/chronic pelvic pain syndrome: a randomized double-blind, placebo-controlled study. Urology 2006;67(1):60-63. 101. Shoskes DA, Zeitlin SI, Shahed A and Rajfer J. Querectin in men with category III chronic prostatitis: a preliminary prospective, doubleblind, placebo control trial. Urology 1999;54:960-963. 102. Giubilei G, Mondaini N, Minervini A, et al . Physical activity of men with chronic prostatitis/ chronic pelvic pain syndrome not satisfied with conventional treatments- could it represent a valid option? The physical activity and male pelvic pain trial: a double-blind randomized study. J Urol 2007;177:159-165. 103. Chen R and Nickel JC. Acupuncture ameliorates symptoms in men with chronic prostatitis/chronic pelvic pain snydrome. Urology 2003;61:1156-1159. 104.Persson B, Rondquist G, Ekblom M. Ameliorative effect of allopurinol on non-bacterial prostatitis: a parallel double-blind controlled study. J Urol 1996;155:961-964. 105.Ye Z-Q, Cai D, Lan R-Z, et al. Biofeedback therapy for chronic pelvic pain syndrome. Asian J Androl 2003;5:155-158. 106.Clemens JQ, Nadler RB, Schaeffer AJ, Belani J, Albaugh J and Bushman W. Biofeedback, pelvic floor re-education, and bladder training for male chronic pain syndrome. Urology 2000;56:951-955. 107.Chuang JC and Chancellor MB. The application of botulinum toxin in the prostate. J Urol 2006;176(6):2375-2382. 108. Turini D, Beneforti P, Spinelli M, Malagutti S and Lazzeri M. Heat/burning sensation induced by topical application of capsaicin on perineal cutaneous area: new approach in diagnosis and treatment of chronic prostatitis/chronic pelvic pain syndrome? Urology 2006;67(5):910-913.

109.Rugendorf EW, Weidner W, Ebeling, et al. Results of treatment with pollen extract ( cernilton N) in chronic prostatitis and prostatdynia. Br J Urol 1993:71:433-438. 110. Kastner C, Hochreiter W, Huidobro, et al. Cooled transurethral microwave thermotherapy for intractable chronic prostatitis- results of a pilot study after 1 year. Urology 2004;64(6):1149-1154. 111.Bates SM, Hill VA, Anderson JB, et al. A prospective ,randomized double-blind trial to evaluate the role of a short reducing course of oral corticosteroid therapy in the treatment of chronic prostatitis/chronic pelvic pain syndrome. BJU Int 2007;99:355-359. 112. Lee CB, Ha U-S, Lee SJ, et al. Preliminary experience with a terpene mixture versus ibuprofen for treatment of category III chronic prostatitis/chronic pelvic pain syndrome. World J Urol 2006;24(1):55 113.Anderson RA, Wise D, Sawyer T and Chan C. Integration of myofascial trigger point release and paradoxical relaxation training treatment of chronic pelvic pain in men. J Urol 2005;174:155-160. 114. Shoskes DA and Zeitlin SI. Use of prostatic massage in combination with antibiotics in the treatment of chronic prostatitis. Prostate Cancer Prostatic Dis 1999;2:159-162. 115. Potts JM, ODougherty E. Pelvic floor physical therapy for patient with prostatitis. Curr Urol Rep 2000;1(2):155-158. 116. Nickel JC, Forrest JB, Tomera K, et al. Pentosan polysulfate Sodium therapy for men with chronic pelvic pain syndrome: a mulitcenter, randomized, placebo-controlled study. J Urol 2005;173:1252-1255. 117. Van Balken MR, Vandoninck V, Messelink BJ. Percutaneous tibial nerve stimulation as neuromodulative treatment of chronic pelvic pain. Eur Urol 2003;43:158-163. 118. Leippold T, Strebel RT, Huwyler M, et al. Sacral magnetic stimulation in non-inflammatory chronic pelvic pain syndrome. BJU Int 2005;95:838-841 119. Lee RA, West RM and Wilson JD. The response to sertraline in men with chronic pelvic pain syndrome. Sex Transm Inf 2005;81:147-149. 120.Leskinen MJ, Kilponen A, Lukkarinin O and Tammela TLJ. Transurethral Needle Ablation for the treatment of chronic pelvic pain syndrome (category III prostatitis): a randomized, sham-controlled study. Urology 2002;60:300-304. 121. John H, Ruedi C, Kotting S, Schmid DM, Fatzer M and Hauri D. A new high frequency electrostimulation device to treat chronic prostatitis. J Urol 2003;170:1275-1277. 122. Goldmeier D, Madden P, McKenna M and Tamm N. Treatment of category IIIA prostatitis with zafirlukast: a randomized controlled feasibliity study. Int J STD and AIDS 2005;16(3):196-200. 123. Saarto T, Wiffen PJ. Antidepressants for neuropathic pain. Cochrane Database Syst Rev 2007;(4):CD005454. 124. Turner JA, Ciol MA, Von Korff M and Berger R. Prognosis of Patients with New Prostatitis/Pelvic Pain Syndrome Episodes. J Urol 2004;172:538-541

125. Nickel JC, Downey JA, Nickel KR and Clark JM. Prostatitis-like symptoms; one year later. BJU Int 2002;90:678-681. 126.Shoskes DA, Landis JR, Wang Y, et al. Impact of ejaculatory pain in men with category III chronic prostatitis/chronic pelvic pain syndrome. J Urol 2004;172:542-547. 127. Meares EM Jr, Stamey TA. Bacterial localisation patterns in bacterial prostatitis and urethritis. Invest Urol 1968;5:492-518.

Appendix 1 Four-glass test (lower urinary tract localisation procedure; MearesStamey test) [127] Preparation No antibiotics should have been taken for one month. The patient should not have ejaculated for two days. The patient should have a full but not distended bladder. Prostatic massage should not be performed if there is evidence of urethritis or urinary tract infection. If either of these is present they should first be treated to prevent prostatic secretion contamination. Prostatic massage The foreskin should be fully retracted and the penis well cleaned to prevent contamination. A 5-10 ml sample of first-void urethral urine (VB1) should be collected. The patient should pass a further 100-200 ml urine and then a further 5-10 ml sample of mid-stream bladder urine (VB2) should be collected. By digital rectal examination a vigorous massage of the prostate gland should be performed for 1 minute, from periphery towards the midline with a sterile container held over the glans to collect any expressed prostatic secretions (EPS). A wet preparation microscopic examination of a sample of EPS should be made to determine the number of polymorphonuclear leucocytes (PMNL) per high power field (x 400). Immediately after the massage another 5-10 ml post-massage urine (VB3) should be collected. All three urine samples should have microscopy and quantitative culture. A dry prostatic massage is reasonably common Interpretation of results To assign an organism to the prostate, the colony count in the EPS and VB3 is required to be at least 10 times greater than in VB1-2. For prostatic inflammation 10 PMNL/high power field (hpf) is considered diagnostic. In cases of a dry expressate a PMNL count of 10/hpf greater in VB3 than VB1 and VB2 is diagnostic of prostatitis. The presence of clumps of PMNL (5+) and oval fat bodies (macrophages containing fat droplets) in the EPS support the diagnosis of inflammatory CP/CPPS. If there is significant bacteruria in both VB2 and VB3, 3 days of nitrofurantoin 50mg four times daily, which is not prostate penetrating, should be given and the procedure then repeated.

Appendix 2 NIH- Chronic Prostatitis Symptom Index (NIH-CPSI)

NIH Chronic Prostatitis Symptom Index

Developed by the NIDDK-funded Chronic Prostatitis Collaborative Research Network Read an abstract about the NIH symptom index Pain or discomfort 1. In the last week, have you experienced any pain or discomfort in the Yes following areas? Area between rectum and testicles (perineum)
1 1 1 1

No
0 0 0 0

0 0 0 0

Testicles Tip of the penis (not related to urination) Below your waist, in your pubic or bladder area 2. In the last week, have you experienced: Pain or burning during urination? Pain or discomfort during or after sexual climax (ejaculation)? 3. How often have you had pain or discomfort in any of these areas over the last week? Never Rarely Sometimes Often Usually Allways 4. Which number best describes your AVERAGE pain or discomfort on the days that you had it over the last week? 0 no pain 1 2 3 4 5 6 7 8 9 10 Pain bad as you can imagine

Yes
1 1

No
0 0

0 0

0 1 2 3 4 5

Urination 5. How often have you had a sensation of not emptying your bladder completely after you finished urinating during the last week? Not at all Less than 1 time in 5 Less than half time About half time More than half time Almost always
Modified with permission from Litwin MS, McNaughton-Collins M ' Fowler FJ, et al. The NIH Chronic Prostatitis Symptom index (NIH-CPSI). Development and validation of a new outcomes measure. J Urol. In press. 0 1 2 3 4 5

6. How often have you had to urinate again less than 2 hours after you finished urinating, over the last week? Not at all Less than 1 time in 5 Less than half time About half time More than half time Almost always Impact of symptoms 7. How much have your symptoms kept you from doing the kinds of things you would usually do, over the last week? None Only a little Some A lot 8. How much did you think about your symptoms during the last week? None Only a little Some A lot Quality of life 9. If you were to spend the rest of your life with your symptoms just the way they have been during the last week, how would you feel about that? Delighted Pleased
0 1 0 1 2 3 0 1 2 3 0 1 2 3 4 5

Mostly satisfied Mixed (about equally satisfied and dissatisfied) Mostly dissatisfied Unhappy Terrible Scoring the Symptom Index Domains Pain:Total of items 1 a, 1 b, 1 c, 1 d, 2a, 2b, 3, and 4 Urinary symptoms:Total of items 5 and 6 Quality of life impact:Total of items 7, 8, and 9 Pain and urinary score:Total of item 1 to 6 Total score:

2 3 4 5 6

0 0 0 0 0

(1) Calculate and report 3 separate scores (pain, urinary symptoms, and quality of life) (2) Calculate and report a pain and urinary score (range 0-31), referred to as the "symptom scale score." Mild =0-9, moderate=10-18 severe=19-31. (3) Calculate and report total score (range 0-43), referred to as the "total score." Assess patients at baseline and follow them over time using each patient as his own control. Can also use to compare to "norms" established and published.

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