Chronic Prostatitis Collaborative Research Network Cohort Study (CPCRN Cohort)

General Description

Chronic prostatitis is a disabling condition of unknown origin affecting men of all ages and ethnic groups. Most have chronic pelvic pain associated with urinary frequency and urgency; however, they do not have demonstrable urinary or prostatic infections that can be detected by conventional microbiological techniques. In response to the growing concerns about the diagnosis and treatment of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), the Chronic Prostatitis Collaborative Research Network (CPCRN), which consists of six clinical centers and one data coordinating center, was established to study this syndrome in order to improve diagnosis and treatment.

The CPCRN conducted a prospective observational cohort study designed to characterize CP/CPPS, examine symptoms and quality of life in affected men, and assess the economic impact of the condition. Men of any age with symptoms of discomfort or pain in the pelvic region for at least 3 of the 6 months prior were eligible for enrollment. The CPCRN cohort study consisted of a baseline screening phase and a longitudinal follow-up phase. During the baseline screening phase, eligibility criteria were assessed, and baseline data and biospecimens (including serum, prostatic fluid, and semen) were collected. Information on symptoms and quality of life, demographic and lifestyle factors, medical history, prior treatments and procedures, and health resource utilization was collected.

The study found that CP/CPPS is a multifactorial problem affecting men of all ages and demographics. The condition is characterized by substantial variation in symptoms within and among subjects. There is no evidence that the disorder worsens significantly during 2 years of follow-up, and for about a third of men with long-standing symptoms there may be moderate to marked improvement during this period. Men with chronic prostatitis experience impairment in the mental and physical domains of general health related quality of life, and many have benefited only minimally from empirical, goal-directed therapy. The CPCRN has conducted numerous clinical trials to investigate the safety and efficacy of numerous treatments for CP/CPPS, for which more details are available on the NIDDK Repository website.

Objectives

The primary objective of the study was to characterize CP/CPPS by examining the diagnosis, symptoms, and quality of life in affected men and assessing the economic impact of the condition.

Outcome Measure

Clinical and laboratory values from physical examination and laboratory studies, the NIH Chronic Prostatitis Symptom Index (NIH-CPSI), and quality of life assessments were used as outcome measures.

Criteria

Participants included men of all ages who had experienced symptoms of discomfort or pain in the pelvic region for at least 3 of the 6 months prior to the baseline screening visit. Men who had used antimicrobial agents, had an active genitourinary infection, or a prostate biopsy within the past three months were deferred for 3 months, and at that time they were allowed to enter into the study.

Exclusion criteria are documented in the study protocol.

Outcome

The study found that CP/CPPS is a multifactorial problem affecting men of all ages and demographics. The condition is characterized by substantial variation in symptoms within and among subjects. There is no evidence that the disorder worsens significantly during 2 years of follow-up, and for about a third of men with long-standing symptoms there may be moderate to marked improvement during this period. Men with chronic prostatitis experience impairment in the mental and physical domains of general health related quality of life, and many have benefited only minimally from empirical, goal-directed therapy. The CPCRN has conducted numerous clinical trials to investigate the safety and efficacy of numerous treatments for CP/CPPS, for which more details are available on the NIDDK Repository website.