Chronic Prostatitis Collaborative Research Network Research Articles

Clustering of UPOINT Domains and Subdomains in Men with Chronic Prostatitis/Chronic Pelvic Pain Syndrome and Contribution to Symptom Severity

The UPOINT (Urinary, Psychosocial, Organ specific, Infection, Neurologic/systemic and Tenderness of skeletal muscle) system characterizes men with chronic prostatitis/chronic pelvic pain syndrome according to 6 domains. Some domains have multiple possible criteria but to our knowledge grouping these criteria have never been validated. Domain clustering may provide clues to the etiology or treatment of individual phenotypes. We examined domain clustering patterns and the contribution of individual domains and subdomains to symptom severity. We reviewed the records of 220 patients with chronic prostatitis/chronic pelvic pain syndrome. Of the patients 120 were characterized by UPOINT alone and 100 were characterized by subdomain, including urinary (voiding and storage), psychosocial (catastrophizing and depression), organ specific (bladder and prostate), infection (prostate and urethra) and neurologic/systemic. The NIH-CPSI (National Institutes of Health-Chronic Prostatitis Symptom Index) was used to measure symptom severity. The urinary, psychosocial, infection and neurologic/systemic subdomains had a similar incidence but organ specific-prostate was more common than organ specific-bladder (51% vs 33%). On cluster analysis with multidimensional scaling urinary, organ specific and tenderness clustered together, as did neurologic, infection and psychosocial. Of the subdomains organ specific-prostate and organ specific-bladder diverged but the others clustered together. The domains that significantly contributed to the total NIH-CPSI score were urinary, psychosocial and tenderness. Only psychosocial contributed independently to the quality of life subscore. UPOINT domain criteria capture a homogeneous group for each domain except organ specific, in which bladder and prostate diverge. Clustering of domains specific to the pelvis (urinary, organ specific and tenderness) vs systemic domains (neurologic, infection and psychosocial) implies 2 patient populations that may differ in pathophysiology and treatment response. The primary drivers of pain in patients with chronic pelvic pain syndrome are pelvic floor tenderness, depression and catastrophizing.

The DABBEC Phenotyping System: towards a mechanistic understanding of CP/CPPS

There is an urgent need to elucidate the mechanistic basis of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), as the current methods of symptom-based diagnosis and treatment have failed. Here, we propose a phenotyping system that bridges the gap between the symptom-based diagnosis and treatment of the present and the mechanistic approach of the future. Our phenotyping system uses the Chronic Prostatitis Collaborative Research Network (CPCRN)-recommended algorithm in combination with the NIH Chronic Prostatitis Symptom Index (NIH-CPSI) as a basis for diagnosis, while incorporating novel domains for quantitative assessment and stratification of CP/CPPS patients. We believe this novel system will serve to help advance our understanding of the roles of the patient's genome and proteome in the etiology of CP/CPPS. We predict that, as we begin to understand the mechanistic basis of CP/CPPS pathology and progression, we will develop specific treatments that will aim to cure the disease, rather than merely quell the symptoms.

A Retrospective Study: Correlation of Histologic Inflammation in Biopsy Specimens of Chinese Men Undergoing Surgery for Benign Prostatic Hyperplasia With Serum Prostate-specific Antigen

To reveal the correlation between benign prostatic hyperplasia (BPH) histologic inflammation and serum prostate-specific antigen (sPSA) concentrations, and the possible mechanism. Patients underwent surgery at the Urology Department of West China Hospital of Sichuan University were retrospectively studied. Preoperative sPSA and transrectal ultrasonography were measured. According to the histopathological classification system for chronic prostatic inflammation proposed by the Chronic Prostatitis Collaborative Research Network (CPCRN) and the International Prostatitis Collaborative Network (IPCN), we classified the histologic sections of prostatic biopsy into glandular, periglandular, and stromal inflammation by the anatomical location of inflammatory infiltration. The glandular inflammation was graded according to the inflammatory aggressiveness. The periglandular and stromal inflammation were graded according to the inflammatory density. The correlation between histologic inflammation and sPSA was studied by a multiple regression model in conjunction with age and total prostatic volume. A total of 454 patients with exclusively BPH were analyzed. The periglandular inflammatory infiltration was the most common pattern (95.6%). Single regression analysis revealed that total prostatic volume, the aggressiveness of glandular inflammation, and the intensity of periglandular and stromal inflammation were correlated with sPSA. However, the multiple regression analysis revealed that only the total prostatic volume and the aggressiveness of glandular inflammation were correlated significantly with sPSA (R = .389, 0.289; P = .000). The aggressiveness of glandular inflammatory infiltration in BPH is a significant contributor to elevated sPSA levels. The theory of leakage may be the most reasonable mechanism to reveal the correlation morphologically. We should take inflammation into consideration when interpreting the abnormal elevating of sPSA levels.

800 CATASTROPHIZING AND SPOUSAL RESPONSES IN MEN SUFFERING FROM CHRONIC PROSTATITIS/CHRONIC PELVIC PAIN SYNDROME (CP/CPPS)

You have accessJournal of UrologyInfections/Inflammation of the Genitourinary Tract: Prostate & Genitalia1 Apr 2010800 CATASTROPHIZING AND SPOUSAL RESPONSES IN MEN SUFFERING FROM CHRONIC PROSTATITIS/CHRONIC PELVIC PAIN SYNDROME (CP/CPPS) Dean A. Tripp, Jessica Ginting, J. Curtis Nickel, Kathleen J. Propert, and John Kusek Dean A. TrippDean A. Tripp Kingston, Canada More articles by this author , Jessica GintingJessica Ginting Kingston, Canada More articles by this author , J. Curtis NickelJ. Curtis Nickel Kingston, Canada More articles by this author , Kathleen J. PropertKathleen J. Propert Philadelphia, PA More articles by this author , and John KusekJohn Kusek Chronic Prostatitis Collaborative Research Network, Bethesda, MD More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2010.02.1476AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Catastrophic thinking about one's pain symptoms and ability to self-manage strongly influences patient adjustment, as does spousal support. We examined the moderating impact of psychosocial factors like catastrophizing and spousal responses on the relationship between pain and quality of life (QoL), and pain and disability in men suffering from CP/CPPS. METHODS One-hundred and eighty-eight men with CP/CPPS completed a set of questionnaires, which included demographic information, catastrophizing (Pain catastrophizing Scale), pain (Short-Form McGill Pain Questionnaire), disability (PDI), and QoL (SF-12). In addition, the types of pain-coping support responses men reported experiencing from their female spouses was assessed (West Haven-Yale Multidimensional Pain Inventory). Moderating models tested whether high or low levels of catastrophizing or spousal social support would create different associations between pain and QoL as well as pain and disability. RESULTS The mean age of the subjects was 48.4 years (SD=10.8) most were employed (76%) and 65% had a high school education or less. The association between pain and mental QoL was strongest when men reported higher levels of catastrophizing (β=-0.29,p=.00) compared to men reporting lower levels of catastrophizing (β=0.07,p=.59). The association between pain and disability was strongest when levels of solicitous spousal support (doing more tasks and work for their partners) was rated high by the patients (β=0.51,p=.00) compared to when it was rated as low by the patients (β=0.12,p=.30). All other models were not significant. CONCLUSIONS The association between pain and poorer QoL was amplified when examined across higher versus lower levels of catastrophizing. With other mounting evidence of the negative effects of catastrophizing appraisals for clinical and psychosocial outcomes, this data clearly calls for review and reduction of this particular pain appraisal in CP/CPPS. The association between pain and disability was also amplified when female spouses were reported to provide higher levels of solicitous support for males with CP/CPPS than at lower levels. This is a novel finding but no direction of cause can be offered for these data. The solicitous support from the spouse may be a reaction to patient pain and associated disability, or alternatively, solicitous support may help create or maintain the patient's pain and disability. This clarification must await future longitudinal couples studies. © 2010 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 183Issue 4SApril 2010Page: e312-e313 Advertisement Copyright & Permissions© 2010 by American Urological Association Education and Research, Inc.MetricsAuthor Information Dean A. Tripp Kingston, Canada More articles by this author Jessica Ginting Kingston, Canada More articles by this author J. Curtis Nickel Kingston, Canada More articles by this author Kathleen J. Propert Philadelphia, PA More articles by this author John Kusek Chronic Prostatitis Collaborative Research Network, Bethesda, MD More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

The Prevalence of Prostatitis-Like Symptoms in China

We studied the prevalence of prostatitis-like symptoms and identified their associated risk factors in a population based Chinese sample. A volunteer group of 15,000 eligible men residing in Beijing, Anhui, Xi'an, Guangzhou and Gansu cities or provinces were invited randomly to take part in the survey to complete a questionnaire that elicited information regarding sociodemographics, Eysenck personality questionnaire, current stress and health ratings, lifestyle, medical history, expressed prostatic secretion evaluation, score of the National Institutes of Health Chronic Prostatitis Symptom Index and International Index of Erectile Function-5. Information on 12,743 (84.95%) men was collected. Of these men 1,071 (8.4%) reported prostatitis-like symptoms (mean National Institutes of Health Chronic Prostatitis Symptom Index pain score 7.55 +/- 3.22). The percent of chronic prostatitis was 4.5% (571) among the symptoms group according to past urological history and expressed prostatic secretion evaluation. Subjects with prostatitis-like symptoms (mean age 34.56 +/- 13.48 years) had higher mean pain and urinary symptoms scores (7.53 +/- 3.22 and 2.84 +/- 2.72, respectively) compared with subjects without prostatitis-like symptoms (1.18 +/- 2.32 and 0.72 +/- 1.66 for pain and urinary symptoms scores, respectively, mean age 30.7 +/- 10.17) (pain and symptoms scores, p <0.05). The quality of life score was 6.03 +/- 2.88 and 3.83 +/- 2.55 in groups with symptoms or nonsymptoms, respectively (p <0.05). Prostatitis-like symptoms are a multifactorial problem affecting men of all ages (15 to 60 years) and demographics, and the prevalence is high in China. The syndrome is closely related to alcohol consumption, cigarette smoking, frequent intercourse, as well as fatigue, pressure and too little sleep. These findings suggest that risk factors for this condition are largely modifiable and highlight potential targets for future prevention.

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.

Intraprostatic Botulinum Toxin A Injection Inhibits Cyclooxygenase-2 Expression and Suppresses Prostatic Pain on Capsaicin Induced Prostatitis Model in Rat

Cyclooxygenase-2 is a key enzyme in the conversion of arachidonic acid to prostaglandins, which are important mediators of inflammation and pain. We investigated the effect of intraprostatic botulinum toxin A administration on pain reaction and cyclooxygenase-2 expression in a capsaicin induced prostatitis model in rats. Adult male Sprague-Dawley rats were injected with vehicle or capsaicin (10 mM, 0.1 cc) into the prostate. The nociceptive effects of capsaicin were evaluated for 30 minutes using a behavior approach. The prostate and L6 spinal cord were then removed for histology and cyclooxygenase-2 expression using Western blotting or immunostaining. A second set of animals was injected with botulinum toxin A (5 to 20 U) into the prostate 1 week before intraprostatic injection of capsaicin. Capsaicin induced increased pain behavior and inflammatory reaction. Botulinum toxin A 1 week before treatment dose dependently decreased inflammatory cell accumulation, cyclooxygenase-2 expression and prostatic pain. Botulinum toxin A (20 U) significantly decreased inflammatory cell accumulation, and cyclooxygenase-2 expression in the prostate, ventral horn and dorsal horn of the L6 spinal cord (93.5%, 89.4%, 90.5% and 77.5%, respectively). It decreased pain behavior for eye and locomotion scores (59.5% and 40.0%, respectively). Intraprostatic capsaicin injection activates cyclooxygenase-2 expression in the prostate, and spinal sensory and motor neurons, and it induces prostatic pain. Botulinum toxin A pretreatment could inhibit capsaicin induced cyclooxygenase-2 expression from the peripheral organ to the L6 spinal cord and inhibit prostatic pain and inflammation. This finding suggests a potential clinical benefit of botulinum toxin A for the treatment of nonbacterial prostatitis.

Epidemiology and evaluation of chronic pelvic pain syndrome in men

Chronic pelvic pain syndrome (CPPS), formerly known as chronic abacterial prostatitis, is characterised by pelvic or perineal pain without evidence of urinary tract infection. It manifests as pain in a variety of areas including the perineum, rectum, prostate, penis, testicles and abdomen [Litwin MS, McNaughton-Collins M, Fowler Jr FJ, Nickel JC, Calhoun EA, Pontari MA, et al. The National Institutes of Health chronic prostatitis symptom index: development and validation of a new outcome measure. Chronic Prostatitis Collaborative Research Network. J Urol 1999;2:369–75]. It is also frequently associated with symptoms including urinary urgency, frequency, hesitancy and poor or interrupted flow. CPPS may be associated with white cells in the prostatic secretions (inflammatory) (NIH-3A), or white cell absence in the prostatic secretions (non-inflammatory) (NIH-3B) [Krieger JN, Nyberg Jr L, Nickel JC. NIH consensus definition and classification of prostatitis. JAMA 1999;3:236–7].

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

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

Demographic and Clinical Characteristics of Chronic Prostatitis: Prospective Comparison of the University of Sciences Malaysia Cohort With the United States National Institutes of Health Cohort

We compared demographic and clinical characteristics of the University of Sciences Malaysia Chronic Prostatitis Cohort to the United States National Institutes of Health Chronic Prostatitis Cohort. Participants met the same definition of chronic prostatitis/chronic pelvic pain syndrome. Each participant had extensive demographic, medical history, previous treatment, clinical and laboratory evaluations. The University of Sciences Malaysia and National Institutes of Health cohorts proved similar in most respects. National Institutes of Health-Chronic Prostatitis Symptom Index total scores, pain and urinary subscores were similar for the 332 University of Sciences Malaysia Chronic Prostatitis Cohort and 488 National Institutes of Health Chronic Prostatitis Cohort participants. Differences included worse quality of life subscore for the University of Sciences Malaysia Chronic Prostatitis Cohort, differences in the location, number of sites, and types of pain/discomfort between the 2 populations, and that the University of Sciences Malaysia participants had received less previous treatment. The demographic characteristics and clinical presentation of chronic prostatitis/chronic pelvic pain syndrome proved remarkably similar in these diverse populations. Both cohorts experienced major reduction in their quality of life from chronic pelvic pain and urinary symptoms. Comparison of diverse populations using standard clinical, laboratory and assessment instruments is feasible, and may provide important insights into chronic prostatitis/chronic pelvic pain syndrome and the factors that determine clinical outcome.

Validity and Reliability of the Arabic Version of the National Institutes of Health Chronic Prostatitis Symptom Index

Introduction: In order to accurately assess the extent of chronic pelvic pain syndrome (CPPS) and to objectively measure symptoms for natural history studies and to assess the outcome parameters for clinical trials, the National Institutes of Health (NIH) Chronic Prostatitis Collaborative Research Network developed and validated the NIH Chronic Prostatitis Symptom Index (NIH-CPSI). The aim of the current study was to develop and validate a fluent and comprehensive Arabic version of the NIH-CPSI. Methods: This study consisted of 80 consecutive male patients affected by CPPS and 80 healthy controls who were asked to complete the Arabic version of the NIH-CPSI. The translation was performed by a group consisting of an andrologist and professional translators. Psychometric data were collected. Results: Of the 160 subjects enrolled, 82 (50 patients and 32 controls) completed the study. The total Arabic NIH-CPSI scores and the scores of each subscale differed significantly between the two groups with good discriminant validity. The questionnaire had also a high internal consistency. Conclusion: The present study provides the Arabic version of the NIH-CPSI and recognizes it as a valid and reliable tool in the assessment of local patients with CPPS.

Predictors of Symptom Severity in Patients With Chronic Prostatitis and Interstitial Cystitis

Numerous studies have been performed to identify potential risk factors for CP/CPPS and IC. However, few studies have been done to identify predictors of disease severity. A total of 174 men with CP/CPPS and 111 women with IC completed questionnaires to quantify symptom severity and identify demographic, medical and psychosocial characteristics. Symptom severity was assessed with the National Institutes of Health CPSI in men, and the O'Leary-Sant ICSI and problem index in women. Univariate and multivariate analyses were performed to identify characteristics predictive of worse symptoms. The mean National Institutes of Health CPSI score in men was 15.32, and the mean O'Leary-Sant ICSI and problem index in women was 19.17. The most commonly reported comorbidities were allergies, sinusitis, erectile dysfunction and irritable bowel syndrome in men, and allergies, urinary incontinence, sinusitis and irritable bowel syndrome in women. In the 2 sexes self-reported urinary frequency and urgency, worse depression scores and lower education level were independent predictors of worse symptom severity. In men additional independent predictors were self-reported pelvic pain, fibromyalgia and previous heart attack, and in women an additional independent predictor was postmenopausal status. There are several common medical conditions associated with urological pelvic pain syndromes in men and women. Few of them were predictive of symptoms severity in this analysis. Self-reported pelvic pain symptoms, education and depression severity were the factors most strongly predictive of symptom severity in patients with CP/CPPS and IC.

INTERSTITIAL CYSTITIS, CHRONIC NONBACTERIAL PROSTATITIS AND CHRONIC PELVIC PAIN SYNDROME IN MEN: A COMMON AND FREQUENTLY IDENTICAL CLINICAL ENTITY

In this ongoing review we characterize interstitial cystitis in men, identifying multiple clinical factors in the diagnosis and treatment of men with interstitial cystitis. An ongoing and retrospective chart review of 92 men with interstitial cystitis within our large single specialty practice was performed. Presenting complaints, duration of symptoms, epidemiology, and clinical and physical findings were reviewed. All patients met National Institute for Diabetes and Digestive and Kidney Diseases criteria for the diagnosis of interstitial cystitis. Of the patients 83% were white and 17% were American Indians of Cherokee descent. Average patient age at diagnosis was 51 years and average duration of symptoms was 8.8 years. The most commonly reported initial complaints were mild suprapubic discomfort, which rapidly progressed in an average of 21/2 years to severe suprapubic discomfort, severe dysuria and severe urinary frequency. Sexual dysfunction occurred in 60% of patients with painful ejaculation. The most common physical findings were suprapubic tenderness to palpation and anterior rectal wall tenderness on digital rectal examination. Of the patients 40% had microscopic hematuria. All patients demonstrated severe glomerulations under anesthesia with cystoscopy and hydraulic distention of the bladder. Average bladder volume was 510 cc. Interstitial cystitis in males appears to be more common than historically reported. Interstitial cystitis in males and patients with chronic pelvic pain syndrome and chronic nonbacterial prostatitis share many clinical findings. A higher incidence of interstitial cystitis had been found in American Indian males of Cherokee descent and deserves further investigation.

Treatment of chronic prostatitis

Diagnosis and treatment of chronic prostatitis are presently based on unsupported assumptions and a nonvalidated classification scheme. Here, Richard Alexander summarizes research by the Chronic Prostatitis Collaborative Research Network that challenges the assumptions and indicates that ongoing empiric administration of antimicrobial drugs to men with long-standing prostatitis should be abandoned.

NIDDK-sponsored Chronic Prostatitis Collaborative Research Network (CPCRN) 5-year data and treatment guidelines for bacterial prostatitis

Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a disabling condition that is poorly understood. The National Institutes of Diabetes and Digestive and Kidney Diseases-sponsored Collaborative Research Network has developed a symptom index, formed a cohort study, a case control study, a full-scale randomised clinical trial, a resource utilisation study and clinical trials, as well as basic research studies, in an effort to better understand and manage patients with this condition. Cohort, case control and resource utilisation studies have confirmed the substantial impact of CP/CPPS. Clinical trials in basic research suggest that anti-inflammatory therapy and alpha-blocker therapy may be effective. The minority of patients with acute or chronic bacterial prostatitis continues to respond favourably to oral fluoroquinolone therapy.

ASSOCIATION OF PROSTATIC INFLAMMATION WITH DOWN-REGULATION OF MACROPHAGE INHIBITORY CYTOKINE-1 GENE IN SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA

Our previous DNA microarray analyses revealed that the macrophage inhibitory cytokine-1 (MIC-1) gene was significantly down-regulated in symptomatic benign prostatic hyperplasia (BPH) samples. We compared the histopathological features of inflammatory changes in prostate adenoma tissues from individuals with symptomatic and asymptomatic (histological only) BPH using MIC-1 mRNA levels. Prostate adenoma tissues were obtained from 25 patients who underwent transurethral prostatectomy to relieve lower urinary tract symptoms due to BPH and 6 patients with bladder cancer who underwent cystoprostatectomy due to bladder cancer. Inflammatory changes in the prostate were examined histopathologically and immunohistochemically, and classified according to the consensus classification system of the Chronic Prostatitis Collaborative Research Network and International Prostatitis Collaborative Network advocated in 2001 with some modification. MIC-1 mRNA was assessed quantitatively by real-time reverse transcriptase-polymerase chain reaction. MIC-1 gene down-regulation was observed in 16 of 25 symptomatic BPH samples (64.0%), whereas MIC-1 mRNA was high in 6 of 6 prostate adenoma samples from patients with bladder cancer (p = 0.0006). MIC-1 gene down-regulation correlated with the grade of glandular/ periglandular inflammatory changes with statistical significance (p = 0.0387). MIC-1 gene down-regulation was found in only 1 of 7 BPH samples with a glandular predominant pattern, whereas it was found in 15 of 24 BPH samples with a mixed type or stromal predominant pattern (p = 0.0373). Gland destruction by inflammatory infiltrates, followed by replacement of the stromal component in symptomatic BPH may be induced by the down-regulation of the MIC-1 gene.

Etiology and management of chronic pelvic pain syndrome in men

Prostatitis results in >2 million physician office visits annually. Characterized by pelvic pain and voiding symptoms, chronic pelvic pain syndrome (CPPS) is poorly defined. The Chronic Prostatitis Collaborative Research Network (CPCRN) has put forward a uniform set of classifications for chronic prostatitis based on pain being the primary symptom. The CPCRN has also created a valid instrument for measuring symptoms: the Chronic Prostatitis Symptom Index. After nonbacterial prostatitis has been diagnosed, treatment of patients should be individualized. The condition may be caused by bladder, prostate, pelvic side wall, or seminal vesicle pathology. In addition to currently used treatments, several new therapies are being investigated after promising pilot studies. Despite the multiple approaches to management of CPPS, no hard and fast guidelines have been developed. This review provides an overview of assessment techniques and management options for men with CPPS.

Recommendations for the evaluation of patients with prostatitis.

Prostatitis is a prevalent, confusing and frustrating clinical presentation for urologists. Three recent international and North American consensus meetings have drafted suggestions for the evaluation of a man presenting with prostatitis. Published consensus statements from the 2000 Washington meeting of the International Prostatitis Collaborative Network, the 2002 Virginia meeting of the National Institutes of Health Chronic Prostatitis Collaborative Research Network and the 2002 Giessen meeting of the International Consensus Conference on Advances in the Diagnosis and Treatment of Prostatitis were examined to develop suggestions for evaluation of the prostatitis patient by urologists. Clinical, laboratory and imaging evaluations for the patient presenting with prostatitis and chronic prostatitis/chronic pelvic pain syndrome can be categorized as basic or mandatory evaluations (which would include a complete history, focused physical examination, and urinalysis/urine culture), further or recommended evaluations (those that are recommended but not mandatory) and optional evaluations in selected patients. As more evidence and data are accumulated and published, these recommendations may eventually evolve into practice guidelines for the evaluation of men presenting with prostatitis symptoms.

A review of the development and validation of the national institutes of health chronic prostatitis symptom index

Chronic nonbacterial prostatitis or chronic pelvic pain syndrome (CPPS) causes morbidity, both through symptoms and associated impairment in health-related quality of life, both of which illustrate the importance of patient-centered outcomes. Despite preliminary work by several investigators, research and clinical efforts to provide help for men afflicted with CPPS have been hampered by the absence of a widely accepted, reliable, and valid instrument to measure symptoms and quality-of-life impact. Investigators from the National Institutes of Health (NIH)-funded Chronic Prostatitis Collaborative Research Network (CPCRN) sought to remedy this problem by developing a psychometrically valid index of symptoms and quality-of-life impact in men with chronic prostatitis. This instrument, now validated in English, Spanish, German, and Korean, is known as the NIH Chronic Prostatitis Symptom Index (NIH-CPSI). It contains 13 items that are scored in 3 discrete domains: pain, urinary symptoms, and quality-of-life impact. In early studies, the NIH-CPSI has been shown to be reliable, valid, and responsive to change. Further work is needed to determine whether it performs as well in minority populations, men seeking care in nonreferral centers, and other diverse populations.

Design of a multicenter randomized clinical trial for chronic prostatitis/chronic pelvic pain syndrome

Objectives. To describe the study design and rationale for the first placebo-controlled, randomized clinical trial to be conducted by the Chronic Prostatitis Collaborative Research Network sponsored by the National Institutes of Health. Methods. The clinical trial will use a 2 by 2 factorial design to evaluate four treatments: placebo, tamsulosin hydrochloride alone, ciprofloxacin alone, and tamsulosin hydrochloride and ciprofloxacin combined. The primary objectives are to compare the efficacy and safety endpoints in patients with chronic prostatitis/chronic pelvic pain syndrome. The study population consists of men with symptoms of discomfort or pain in the pelvic region for at least a 3-month period. One hundred eighty-four participants will be treated for 6 weeks and followed up for an additional 6 weeks. The primary endpoint is the change in the overall National Institutes of Health Chronic Prostatitis Symptom Index from baseline to 6 weeks. Secondary endpoints include a patient-reported global assessment of response and white blood cell counts and cultures in urine, expressed prostatic secretions, and semen. The evaluation of changes from 6 to 12 weeks will be used to assess the durability of the response. Results. This trial was opened to enrollment in July 2001. The study is expected to require 14 months of accrual and follow-up. Conclusions. The issues considered in the design of this clinical trial may provide guidelines for future clinical trials in chronic prostatitis/chronic pelvic pain syndrome.