Alfuzosin and symptoms of chronic prostatitis-chronic pelvic pain syndrome.

BACKGROUND: In men with chronic prostatitis-chronic pelvic pain syndrome, treatment with alpha-adrenergic receptor blockers early in the course of the disorder has been reported to be effective in some, but not all, relatively small randomized trials. METHODS: We conducted a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of alfuzosin, an alpha-adrenergic receptor blocker, in reducing symptoms in men with chronic prostatitis-chronic pelvic pain syndrome. Participation in the study required diagnosis of the condition within the preceding 2 years and no previous treatment with an alpha-adrenergic receptor blocker. Men were randomly assigned to treatment for 12 weeks with either 10 mg of alfuzosin per day or placebo. The primary outcome was a reduction of at least 4 points (from baseline to 12 weeks) in the score on the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) (range, 0 to 43; higher scores indicate more severe symptoms). A 4-point decrease is the minimal clinically significant difference in the score. RESULTS: A total of 272 eligible participants underwent randomization, and in both study groups, 49.3% of participants had a decrease of at least 4 points in their total NIH-CPSI score (rate difference associated with alfuzosin, 0.1%; 95% confidence interval, -11.2 to 11.0; P=0.99). In addition, a global response assessment showed similar response rates at 12 weeks: 33.6% in the placebo group and 34.8% in the alfuzosin group (P=0.90). The rates of adverse events in the two groups were also similar. CONCLUSIONS: Our findings do not support the use of alfuzosin to reduce the symptoms of chronic prostatitis-chronic pelvic pain syndrome in men who have not received prior treatment with an alpha-blocker. (ClinicalTrials.gov number, NCT00103402.)

Overlap of different urological symptom complexes in a racially and ethnically diverse, community-based population of men and women.

OBJECTIVE: To define the prevalence and overlap of symptom patterns traditionally associated with benign prostatic hyperplasia, chronic prostatitis/chronic pelvic pain syndrome, interstitial cystitis/painful bladder syndrome, and incontinence among men and women in a racially and ethnically diverse, community-based population. SUBJECTS AND METHODS: In all, 5506 men and women aged 30-79 years were recruited to participate in the Boston Area Community Health Survey, using a stratified-cluster sampling technique to obtain roughly similar representative samples by age group, gender and race/ethnicity (White, Black, Hispanic). Survey data were collected by bilingual interviewers in subjects' homes. Scales measuring symptom patterns were derived from validated instruments, with minor changes to eliminate different recall periods and overlap in items that might have confused subjects. RESULTS: About a quarter of men and women of all ages met the definition for one or more of the target symptom patterns; there was no significant variation in the prevalence of any of the symptom patterns by race/ethnicity. Overall, approximately 16% of men and women had one symptom pattern, while 7% had overlap patterns. Except for urinary incontinence and interstitial cystitis/painful bladder syndrome in both men and women, the prevalence of all symptom complexes were associated with one another significantly more often that would be expected by chance. CONCLUSIONS: Overlapping patterns of lower urinary tract symptoms and pelvic pain are common. These overlapping patterns present challenges for clinical practice and research, and require further investigation of their causes, diagnosis and optimum treatment.

Use of androgen deprivation therapy for metastatic prostate cancer in older men.

OBJECTIVE: To assess factors associated with early or delayed androgen deprivation therapy (ADT) among men diagnosed with metastatic prostate cancer, and to assess the relationship between ADT and overall survival, as there is uncertainty about the ideal timing for initiating ADT in men with metastatic prostate cancer. PATIENTS AND METHODS: We studied a population-based cohort of American men aged >or=66 years diagnosed with metastatic prostate cancer during 1992-2002 and followed to 2003. We assessed the receipt of ADT early (4 months), or not at all, using multinomial logistic regression to identify factors associated with treatment, and Cox proportional-hazard models to assess whether treatment was associated with survival. RESULTS: Overall, 69.5% of men received early ADT and 7.3% delayed. Adjusted rates of early ADT were lower for black than white men (58.3% vs 71.0%), and of delayed ADT were higher for black than white men (12.7% vs 6.2%). Receipt of ADT was associated with improved survival (adjusted hazard ratio 0.69, 95% confidence interval 0.66-0.73). The benefit of early treatment did not differ from delayed treatment (P = 0.58). CONCLUSIONS: A large minority of men with metastatic prostate cancer, particularly black men, receive delayed or no ADT. Early or delayed ADT was associated with similarly prolonged survival. After controlling for patient and tumour characteristics, survival did not differ by race, and receipt of ADT did not contribute to racial differences in survival.

Psychosocial variables affect the quality of life of men diagnosed with chronic prostatitis/chronic pelvic pain syndrome.

OBJECTIVE: To examine interactions between demographic, pain, urinary, psychological and environmental predictors of quality of life (QOL) in men with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). PATIENTS AND METHODS: In all, 253 men previously enrolled in the National Institutes of Health Chronic Prostatitis Cohort study in North American tertiary-care clinical centres (six in the USA and one in Canada) self-reported with validated instruments, including the QOL subscales of the Short Form-12 (physical, SF12-PCS; and mental, SF12-MCS), demographics, urinary symptoms, depression, current pain, pain coping, 'catastrophizing' (catastrophic thinking about pain), pain control, social support and solicitous responses from a partner. Data were collected through a one-time survey. Covariates determined to be significant were entered into a multivariable regression model predicting SF12-PCS and SF12-MCS. RESULTS: Adjusting for covariates, regression models showed that poorer SF12-PCS scores were predicted by worse urinary function (P < 0.001) and increased use of pain-contingent resting as a coping strategy (P = 0.026). Further, poorer SF12-MCS scores were predicted by greater pain catastrophizing (P = 0.002) and lower perceptions of social support (P< 0.001). In separate follow-up analyses, helplessness was the significant catastrophizing subscale (P < 0.001), while support from family and friends were the significant social support subscales (P = 0.002 and <0.001). CONCLUSIONS: These data suggest that specific coping and environmental factors (i.e. catastrophizing, pain-contingent resting, social support) are significant in understanding how patients with CP/CPPS adjust. These data can be used to develop specific cognitive-behavioural programmes for men with CP/CPPS who are refractory to standard medical therapy.

Category III chronic prostatitis/chronic pelvic pain syndrome: insights from the National Institutes of Health Chronic Prostatitis Collaborative Research Network studies.

Chronic prostatitis/chronic pelvic pain syndrome remains an enigmatic medical condition. Creation of the National Institutes of Health-funded Chronic Prostatitis Collaborative Research Network (CPCRN) has stimulated a renewed interest in research on and clinical aspects of chronic prostatitis/chronic pelvic pain syndrome. Landmark publications of the CPCRN document a decade of progress. Insights from these CPCRN studies have improved our management of chronic prostatitis/chronic pelvic pain syndrome and offer hope for continued progress.

The association of abuse and symptoms suggestive of chronic prostatitis/chronic pelvic pain syndrome: results from the Boston Area Community Health survey.

OBJECTIVE: To determine the effect of reported sexual, physical, or emotional abuse on the symptoms suggestive of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) and to determine the effect of race/ethnicity on these patterns. METHODS: The Boston Area Community Health (BACH) survey used a multi-stage stratified cluster sample to randomly sample 5,506 adults aged 30-79 from the city of Boston. BACH recruited 2,301 men (700 Black, 766 Hispanic, and 835 White). Interviewers administered questions approximating the National Institutes of Health chronic prostatitis symptom index (CPSI), and symptoms suggestive of CP/CPPS were measured by the definition of perineal and/or ejaculatory pain and CPSI pain score of 4+. Questions about previous abuse were obtained from a validated self-administered questionnaire during the home visit. Logistic regression was used to determine the effect of abuse on the likelihood of a man having symptoms suggestive of CP/CPPS. RESULTS: The prevalence of symptoms suggestive of CP/CPPS was 6.5%. Men who reported having experienced sexual, physical, or emotional abuse had increased odds (1.7-3.3) for symptoms suggestive of CP/CPPS. Previous abuse increased both the pain and urinary scores from the CPSI. CONCLUSION: Symptoms suggestive of CP/CPPS are not uncommon in a community-based population of men. For men presenting with symptoms suggestive of CP/CPPS, clinicians may wish to consider screening for abuse.

The impact of a suspicious prostate biopsy on patients' psychological, socio-behavioral, and medical care outcomes.

OBJECTIVE: To evaluate the psychological, socio-behavioral, and medical implications of apparently false-positive prostate cancer screening results. METHODS: One hundred and twenty-one men with a benign prostate biopsy performed in response to a suspicious screening test (biopsy group) and 164 men with a normal prostate-specific antigen (PSA) test result (normal PSA group) responded to a questionnaire 6 weeks, 6 and 12 months after their biopsy or PSA test. RESULTS: The mean (+/-SD) age of respondents was 61+/-9 years (range, 41 to 88 years). One year later, 26% (32/121) of men in the biopsy group reported having worried "a lot" or "some of the time" that they may develop prostate cancer, compared with 6% (10/164) in the normal PSA group (P<.001). Forty-six percent of the biopsy group reported thinking their wife or significant other was concerned about prostate cancer, versus 14% in the normal PSA group (P<.001). Medical record review showed that biopsied men were more likely than those in the normal PSA group to have had at least 1 follow-up PSA test over the year (73% vs 42%, P<.001), more likely to have had another biopsy (15% vs 1%, P<.001), and more likely to have visited a urologist (71% vs 13%, P<.001). CONCLUSION: One year later, men who underwent prostate biopsy more often reported worrying about prostate cancer. In addition, there were related psychological, socio-behavioral, and medical care implications. These hidden tolls associated with screening should be considered in the discussion about the benefits and risks of prostate cancer screening.

Catastrophizing and pain-contingent rest predict patient adjustment in men with chronic prostatitis/chronic pelvic pain syndrome.

UNLABELLED: Cognitive/behavioral and environmental variables are significant predictors of patient adjustment in chronic pain. Using a biopsychosocial template and selecting several pain-relevant constructs from physical, cognitive/behavioral, and environmental predictors, outcomes of pain and disability in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) were explored. Men (n = 253) from a North American multi-institutional NIH-funded Chronic Prostatitis Cohort Study in 6 US and 1 Canadian centers participated in a survey examining pain and disability. Measures included demographics, urinary symptoms, depression, pain, disability, catastrophizing, control over pain, pain-contingent rest, social support, and solicitous responses from a significant other. Regressions showed that urinary symptoms (beta = .20), depression (beta = .24), and helplessness catastrophizing (beta = .29) predicted overall pain. Further, affective pain was predicted by depression (beta = .39) and helplessness catastrophizing (beta = .44), whereas sensory pain was predicted by urinary symptoms (beta = .25) and helplessness catastrophizing (beta = .37). With regard to disability, urinary symptoms (beta = .17), pain (beta = .21), and pain-contingent rest (beta = .33) were the predictors. These results suggest cognitive/behavioral variables (ie, catastrophizing, pain-contingent rest) may have significant impact on patient adjustment in CP/CPPS. Findings support the need for greater research of such pain-related variables in CP/CPPS. PERSPECTIVE: This article explores predictors of patient adjustment in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Cognitive/behavioral variables of catastrophizing and pain-contingent rest respectively predicted greater pain and disability. Catastrophic helplessness was a prominent pain predictor. These findings inform clinicians and researchers on several new variables in CP/CPPS outcomes and suggest future research.

The economic impact of chronic prostatitis.

BACKGROUND: Little information exists on the economic impact of chronic prostatitis. The objective of this study was to determine the direct and indirect costs associated with chronic prostatitis. METHODS: Outcomes were assessed using a questionnaire designed to capture health care resource utilization. Resource estimates were converted into unit costs with direct medical cost estimates based on hospital cost-accounting data and indirect costs based on modified labor force, employment, and earnings data from the US Census Bureau. RESULTS: The total direct costs for the 3 months prior to entry into the cohort, excluding hospitalization, were $126 915 for the 167 study participants for an average of $954 per person among the 133 consumers. Of the men, 26% reported work loss valued at an average of $551. The average total costs (direct and indirect) for the 3 months was $1099 per person for those 137 men who had resource consumption with an expected annual total cost per person of $4397. For those study participants with any incurred costs, tests for association revealed that the National Institutes of Health Chronic Prostatitis Symptom Index (P<.001) and each of the 3 subcategories of pain (P =.003), urinary function (P =.03), and quality-of-life (P =.002) were significantly associated with resource use, although the quality-of-life subscale score from the National Institutes of Health Chronic Prostatitis Symptom Index was the only predictor of resource consumption. CONCLUSIONS: Chronic prostatitis is associated with substantial costs and lower quality-of-life scores, which predicted resource consumption. The economic impact of chronic prostatitis warrants increased medical attention and resources to identify and test effective treatment strategies.

Ciprofloxacin or tamsulosin in men with chronic prostatitis/chronic pelvic pain syndrome: a randomized, double-blind trial.

BACKGROUND: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) in men is principally defined by pain in the pelvic region lasting more than 3 months. No cause of the disease has been established, and therapies are empirical and mostly untested. Antimicrobial agents and alpha-adrenergic receptor blockers are frequently used. OBJECTIVE: To determine whether 6-week therapy with ciprofloxacin or tamsulosin is more effective than placebo at improving symptoms in men with refractory, long-standing CP/CPPS. DESIGN: Randomized, double-blind trial with a 2 x 2 factorial design comparing 6 weeks of therapy with ciprofloxacin, tamsulosin, both drugs, or placebo. SETTING: Urology outpatient clinics at 10 tertiary care medical centers in North America. PATIENTS: Patients were identified from referral-based practices of urologists. One hundred ninety-six men with a National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score of at least 15 and a mean of 6.2 years of symptoms were enrolled. Patients had received substantial previous treatment. MEASUREMENTS: The authors evaluated NIH-CPSI total score and subscores, patient-reported global response assessment, a generic measure of quality of life, and adverse events. INTERVENTIONS: Ciprofloxacin, 500 mg twice daily; tamsulosin, 0.4 mg once daily; a combination of the 2 drugs; or placebo. RESULTS: The NIH-CPSI total score decreased modestly in all treatment groups. No statistically significant difference in the primary outcome was seen for ciprofloxacin versus no ciprofloxacin (P = 0.15) or tamsulosin versus no tamsulosin (P > 0.2). Treatments also did not differ significantly for any of the secondary outcomes. LIMITATIONS: Treatment lasting longer than 6 weeks was not tested. Patients who had received less pretreatment may have responded differently. CONCLUSION: Ciprofloxacin and tamsulosin did not substantially reduce symptoms in men with long-standing CP/CPPS who had at least moderate symptoms.

Decisions about medication use and cancer screening across age groups in the United States.

OBJECTIVE: To describe decision process and quality for common cancer screening and medication decisions by age group. METHODS: We included 2941 respondents to a national Internet survey who made at least one decision about colorectal, breast, and prostate cancer screening, blood pressure or cholesterol medications. Respondents were queried about decision processes. RESULTS: Across the five decisions considered, decision process scores were similar (and generally low) across age groups for medication and cancer screening, indicating that all groups had poor involvement in medical decision making. Overall knowledge scores were low across age groups, with elderly (75+) having slightly higher knowledge about medications vs. younger respondents. Elderly respondents reported similar goals and concerns when making decisions, though placed greater importance of having peace of mind from a normal result for cancer screening vs. younger respondents. CONCLUSION: Across age groups, respondents reported poor decision processes about common medications and cancer screening, despite little evidence of benefit for some interventions (cancer screening, cholesterol lowering medicines in low risk elderly) and possibility of harm in the elderly. PRACTICE IMPLICATIONS: Particular care should be taken to help patients understand both benefit and risk of screening tests and routine medications.

Health-related quality of life, satisfaction, and economic outcome measures in studies of prostate cancer screening and treatment, 1990-2000.

Prostate cancer outcomes research incorporates a broad spectrum of endpoints, from clinical or intermediate endpoints, such as tumor shrinkage or patient compliance, to final endpoints, such as survival or disease-free survival. Three types of nontraditional endpoints that are of growing interest-health-related quality of life (QOL), satisfaction with care, and economic cost impact-hold the promise of improving our ability to understand the full burden of prostate cancer screening and treatment. In this article we review the last decade's published literature regarding the health-related QOL, satisfaction, and economic outcomes of prostate cancer screening and treatment to determine the "state of the science" of outcomes measurement. The focus is the enumeration of the types of outcome measurement used in the studies not the determination of the results of the studies. Studies were identified by searching Medline (1990-2000). Articles were included if they presented original data on any patient-centered outcome (including costs or survival alone) for men screened and treated for prostate cancer. Review papers were excluded unless they were quantitative syntheses of the results of other primary studies. Economic and decision analytic papers were included if they presented information on outcomes of real or hypothetical patient cohorts. Each retrieved article was reviewed by one of the authors. Included papers were assigned one primary, mutually exclusive study design. For the "primary data" studies, information was abstracted on care setting, dates of the study, sample size, racial distribution, age, tumor differentiation, tumor stage, survival, statistical power, and types of outcomes measures (QOL-generic, QOL-cancer specific, QOL-prostate cancer specific, satisfaction, costs, utilities, and other). For the "economic and decision analytic" papers, information was abstracted on stage of disease, age range, outcomes, costs, and whether utilities were measured. Of the 198 included papers, there were 161 primary data papers categorized as follows: randomized trial (n = 28), nonrandomized trial (n = 13), prospective or retrospective cohort study (n = 55), case-control study (n = 0), cross-sectional study (n = 63), and meta-analysis (n = 2). The remaining 37 papers were economic and decision analytic papers. Among the 149 primary data papers that contained patient outcome data, there were 42 standard instruments used, accounting for 44% (179 of 410) of the measures overall. Almost three-quarters (71%) of papers included one, two, or three outcomes measures of all types (standard and nonstandard); three papers included seven outcomes measures, and one paper included nine. Over the 11-year time period, there was a nonstatistically significant trend toward more frequent use of standardized QOL instruments and a statistically significant trend toward increased reporting of race (P = .003). Standardization of measurement of health-related QOL, satisfaction with care, and economic cost effect among men screened and treated for prostate cancer is needed. A core set of similar questions, both generic and disease-specific, should ideally be asked in every study, although investigators should be encouraged to include additional question sets as appropriate to individual studies to get a more complete picture of how patients screened and treated for this condition are doing over time.

Psychological effects of a suspicious prostate cancer screening test followed by a benign biopsy result.

PURPOSE: To evaluate the psychological implications of an apparently false-positive screening result for prostate cancer. METHODS: The sample comprised 167 men with a benign biopsy result in response to a suspicious screening test result (biopsy group) and 233 men with a normal prostate-specific antigen (PSA) test result (control group). The men responded to a questionnaire within about 6 weeks of their biopsy or PSA results. They were asked about demographic characteristics, medical history, psychological effects, biopsy experience, and prostate cancer knowledge. RESULTS: The survey response rate was 85% (400/471). The mean (+/- SD) age of respondents was 60 +/- 9 years (range, 40 to 88 years); 88% (n = 350) were white. Forty-nine percent (81/167) of men in the biopsy group reported having thought about prostate cancer either "a lot" or "some of the time", compared with 18% (42/230) in the control group (P < 0.001). In addition, 40% (67/167) in the biopsy group reported having worried "a lot" or "some of the time" that they may develop prostate cancer, compared with 8% (18/231) in the control group (P < 0.001). CONCLUSION: Men who underwent prostate biopsy more often reported having thought and worried about prostate cancer, despite having received a benign result. This underrecognized human cost of screening should be considered in the debate about the benefits and harms of prostate cancer screening.

Why is prostate cancer screening so common when the evidence is so uncertain? A system without negative feedback.

The degree of enthusiasm for prostate cancer screening seems high given the limited evidence of benefit and the well-documented harms of treatment that include impotence and incontinence. The purpose of this review is to understand the reasons for enthusiasm and positive reinforcement perceived in clinical decisions about whether to screen, whether to choose aggressive therapy for cancer, and in how to view adverse effects following therapy. We discuss a case of a man who must decide whether to undergo prostate-specific antigen screening and treatment to illustrate the kinds of reinforcement that may occur for each decision.Strong positive reinforcement for each decision would make screening and aggressive therapy appear to be successful and the correct decision even if prostate cancer screening and therapy were not beneficial. A physician is positively reinforced for recommending screening, regardless of the test result, because a negative result makes a patient grateful for reassurance and a positive result makes a patient grateful for early detection. A patient who is impotent and incontinent after a decision for curative treatment may attribute his survival to surgery and be grateful for having his cancer cured. Individual experience provides almost no negative feedback that early detection and aggressive treatment may not work. Although reinforcement operates similarly in other medical decisions, the example of prostate cancer provides insight into the strength of the forces at work because the personal harms, which are relatively common and dramatic, are readily discounted or explained away. Even if prostate cancer screening is eventually demonstrated to provide benefit for asymptomatic persons, it is important to appreciate the strength of forces that may act independently of benefit and reinforce decision makers' choices to be aggressive about screening and treatment. Interventions should be considered to temper possible overenthusiasm for screening and treatment.

Psychosocial mechanisms of the pain and quality of life relationship for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS).

INTRODUCTION: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a prevalent, chronic pelvic pain condition largely unresponsive to medical interventions. Psychosocial risk factors are associated with poor outcomes in CP/CPPS, but have not been examined for their intervening roles between pain and reduced quality of life (QoL). This study aimed to determine if psychosocial risk factors (i.e., patient coping and catastrophizing) mediate the association between pain and QoL. METHODS: Using a cross sectional design, 175 men with CP/CPPS (mean age 46.83; SD 10.86) were recruited from tertiary care urology clinics and completed questionnaires on demographics, pain, QoL, pain coping, depression, and catastrophizing. An exploratory factor analysis was conducted and aggregate factor scores were examined to improve the amount of meaningful measurement to be used in multiple mediations. The models specified multiple risk factors as mechanisms between pain and both physical and mental QoL as the primary outcome measurements. RESULTS: Four aggregate psychosocial factor scores were produced from the psychosocial measures (i.e., illness and wellness-focused behavioural coping, depression and catastrophizing). Illness-focused coping partially mediated the relationship between pain and physical QoL. However, catastrophizing and illness-focused coping fully mediated the relation between pain and mental QoL, showing the association between pain and mental QoL was no longer significant when catastrophizing and illness-focused coping were in the model. CONCLUSION: Psychosocial factors function as mechanisms between higher pain and they are associated diminished mental QoL. These results introduce illness-focused coping as an important biopsychosocial target in CP/CPPS management.

A survey of primary care physician practices in the diagnosis and management of women with interstitial cystitis/painful bladder syndrome.

OBJECTIVES: To describe the practice patterns among primary care physicians' (PCPs) managing patients with symptoms suggestive of interstitial cystitis/painful bladder syndrome (IC/PBS). METHODS: We developed a clinical vignette describing a woman with typical IC/PBS symptoms to elicit questions about etiology, management strategies, and familiarity with this syndrome. We mailed the questionnaire to 556 PCPs, including academicians and community physicians, in Boston, Los Angeles, and Chicago. RESULTS: We received 290 completed questionnaires (response rate, 52%). Nineteen percent of respondents reported they had "never" seen a patient like the one described in the vignette. Two-thirds of respondents correctly identified the hallmark symptom of IC/PBS (bladder pain/pressure). Regarding etiology, 90% correctly indicated that IC/PBS was a noninfectious disease, 76% correctly reported that it was not caused by a sexually transmitted infection, and 61% correctly indicated that it was not caused by a psychiatric illness. Common treatments included antibiotics and nonsteroidal anti-inflammatory agents. Referrals were often made to a specialist. CONCLUSIONS: Although most PCPs indicate familiarity with IC/PBS, they manage the condition infrequently. They also appear to have significant knowledge deficits about the clinical characteristics of IC/PBS, and they indicate variable practice patterns in the diagnosis and treatment of the condition. Educational efforts directed at PCPs will likely improve the care of patients with IC/PBS.

Pregabalin for the treatment of men with chronic prostatitis/chronic pelvic pain syndrome: a randomized controlled trial.

BACKGROUND: Evidence suggests that the urogenital pain of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) may be neuropathic. METHODS: This randomized, double-blind, placebo-controlled trial was conducted across 10 tertiary care centers in North America to determine whether pregabalin, which has been proved effective in other chronic pain syndromes, is effective in reducing CP/CPPS symptoms. In 2006-2007, 324 men with pelvic pain for at least 3 of the previous 6 months were enrolled in this study. Men were randomly assigned to receive pregabalin or placebo in a 2:1 ratio and were treated for 6 weeks. Pregabalin dosage was increased from 150 to 600 mg/d during the first 4 weeks. The primary outcome was a 6-point decrease in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score. Multiple secondary outcomes were assessed. RESULTS: Of 218 men assigned to receive pregabalin, 103 (47.2%) reported at least a 6-point decrease in the NIH-CPSI total score at 6 weeks compared with 35.8% (38 of 106 men) assigned to receive placebo (P = .07, exact Mantel-Haenszel test, adjusting for clinical sites). Compared with the placebo group, men assigned to receive pregabalin experienced reductions in the NIH-CPSI total score and subscores (P < .05), a higher Global Response Assessment response rate (31.2% and 18.9%; P = .02), and improvement in total McGill Pain Questionnaire score (P = .01). Results for the other outcomes did not differ between groups. CONCLUSION: Pregabalin therapy for 6 weeks was not superior to placebo use in the rate of a 6-point decrease (improvement) in the NIH-CPSI total score in men with CP/CPPS. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00371033.