Self Management Activation Randomised Trial for Prostatitis (SMART-P): study protocol for a randomised controlled trial

<p>Abstract</p> <p>Background</p> <p>Chronic prostatitis otherwise known as chronic pelvic pain syndrome is a common urological diagnosis that causes many men significant morbidity and has a detrimental effect on their quality of life. Standard treatment with antibiotics and simple analgesia are often ineffective and many patients are managed by the chronic pain services.</p> <p>Cognitive behavioural therapy has been shown to be helpful in the management of many chronic diseases and has recently been proposed as an effective treatment for chronic prostatitis. Furthermore, a self management programme administered to groups of men with lower urinary tract symptoms has been shown to be more effective than standard treatments including surgery.</p> <p>Therefore, we have developed a cognitive behavioural therapy programme specifically for men with chronic prostatitis. This novel treatment approach will be compared to conventional therapy in the pain clinic such as atypical analgesia and local anaesthetic injections in the context of a randomised controlled trial.</p> <p>Methods/Design</p> <p>Men will be recruited from general urology outpatient clinics following the exclusion of other diagnoses that could be responsible for their symptoms. Men will be randomised to attend either a self management healthcare and education programme or to pain clinic referral alone. The self management programme will be administered by a clinical psychologist to small groups of men over six consecutive weekly sessions each lasting two hours. Patients will be taught techniques of problem-solving and goal-setting and will learn coping mechanisms and how to modify catastrophic cognition.</p> <p>The primary outcome will be change from baseline in the National Institute of Health Chronic Prostatitis Symptom Index, a validated instrument for the assessment of men with chronic prostatitis. Secondary outcomes include generic quality of life scores and analgesic and drug usage. Outcomes will be assessed at 2, 6 and 12 months.</p> <p>Discussion</p> <p>If this group administered self management programme is shown to be effective in the treatment of men with chronic prostatitis it may become the new standard of care for these patients. Furthermore, it may be adapted for use in women with interstitial cystitis, a condition which is analogous to chronic prostatitis in men.</p> <p>Trial Registration</p> <p>Current Controlled Trials <a href="http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=ISRCTN21012555">ISRCTN21012555</a></p

PSA levels of 4.0 - 10 ng/ml and negative digital rectal examination: antibiotic therapy versus immediate prostate biopsy

Purpose: The management of mildly elevated (4.0-10.0 ng/ml) prostate specific antigen (PSA) is uncertain. Immediate prostate biopsy, antibiotic treatment, or short term monitoring PSA level for 1-3 months is still in controversy. Material and Methods: We conducted a retrospective chart review of patients in a large community practice (2003 - 2007) who had PSA levels between 4.0-10 ng/mL without any further evidence of infection. Data was gathered regarding patient's age, whether standard antibiotic therapy (10-14 days of ofloxacin or ciprofloxacin) had been administered before the second PSA measurement, results of a second PSA test performed at 1- to 2-month intervals, whether a prostate biopsy was performed and its result. Results: One-hundred and thirty-five men met the study inclusion criteria with 65 (48.1%) having received antibiotics (group 1); the PSA levels decreased in 39 (60%) of which, sixteen underwent a biopsy which demonstrated prostate cancer in 4 (25%). Twenty-six (40%) patients of group 1 exhibited no decrease in PSA levels; seventeen of them underwent a biopsy that demonstrated cancer in 2 (12%). The other 70 (51.9%) patients were not treated with antibiotics (group 2); the PSA levels decreased in 42 (60%) of which, thirteen underwent a biopsy which demonstrated prostate cancer in 4 (31%). In the other 28 (40%) patients of group 2 there was no demonstrated decrease in PSA, nineteen of these subjects underwent a biopsy that demonstrated cancer in 8 (42%). Conclusions: There appears to be no advantage for administration of antibacterial therapy with initial PSA levels between 4-10 ng/mL without overt evidence of inflammation