Chronic Prostatitis Workshop

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December 7- 8, 1995
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
Bethesda, Maryland

• Research and Clinical Definitions
• Diagnostic Evaluation and Treatment Strategies
• Current Research and Future Needs
• Epidemiologic and Health Care Cost Data
• Summary
• Working Groups and Chairs
• Speakers

Background

The purpose of the workshop was to identify current knowledge and help the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) develop a long-range research plan to improve the diagnosis, treatment, and prevention of chronic prostatitis. More than 70 clinicians, researchers, and patients attended and made recommendations to the NIDDK.

The workshop was organized into four working groups:

• Research and Clinical Definitions
• Diagnostic Evaluation and Treatment Strategies
• Current Research and Future Needs
• Epidemiologic and Health Care Cost Data

Groups met individually and presented conclusions to all workshop participants for comment. Their findings are summarized below.

Research and Clinical Definitions

The basis for all future research, clinical evaluation, epidemiologic studies, etc., rests on a uniform definition (diagnostic criteria) for the disease.

Classification and Definition of Prostatitis. The following classifications were approved by the working group chairs and will be the NIDDK reference standard for research studies on these diseases and disorders.

1. Acute bacterial prostatitis is an acute infection of the prostate.
2. Chronic bacterial prostatitis is a recurrent infection of the prostate.
3. Chronic nonbacterial prostatitis/chronic pelvic pain syndrome (CPPS), where there is no demonstrable infection. Subgroups of this class are:
   3.1. Inflammatory chronic pelvic pain syndrome, where white cells are found in the semen, expressed prostatic secretions (EPS), or voided bladder urine-3 (VB-3).
   3.2. Non-inflammatory chronic pelvic pain syndrome, where white cells are NOT found in semen, EPS, and VB-3.
   
4. Asymptomatic inflammatory prostatitis (AIP), where there are no subjective symptoms but white blood cells are found in prostate secretions or in prostate tissue during an evaluation for other disorders.

Workshop participants agreed that chronic nonbacterial prostatitis/CPPS is the most common symptomatic type of prostatitis, and it may be the most prevalent of all prostate diseases, including benign prostatic hyperplasia.

Chronic nonbacterial prostatitis/CPPS has not been scientifically demonstrated to be primarily either a disease of the prostate or the result of an inflammatory process.

Diagnostic Criteria for NIDDK-Sponsored Research Studies. The following criteria were approved for research studies on chronic nonbacterial prostatitis/CPPS.

Inclusion Criteria

• male, at least age 18
• pain or discomfort in the pelvic area (penis, scrotum, perineum, or thereabouts) for at least 3 months

Exclusion Criteria

• the presence of cancer of the genitourinary tract
• active urinary stone disease
• herpes of the genitourinary system
• bacteriuria (100,000 colonies in a midstream urine) within the past 3 months
• antibiotic therapy within the past 3 months
• peri-rectal inflammatory disorders
• inflammatory bowel disease
• history of pelvic radiation or systemic chemotherapy
• history of intravesical chemotherapy
• documented gonorrhea, chlamydia, mycoplasma, or trichomonas infection of the urinary tract within the past 3 months
• clinical epididymitis within the past 3 months
• urethral stricture of 12 French or smaller
• neurological disease or disorder affecting the bladder
• prostate surgery (not including cystoscopy) within the past 3 months

Recommendations

1. The highest priority is to develop and validate a uniform symptom index for chronic nonbacterial prostatitis/CPPS to assess the severity of symptoms. This is necessary for studies addressing the etiology and natural history, and for the development of treatment strategies.
2. Develop and validate outcome measures.
3. Develop a longitudinal database.

Diagnostic Evaluation and Treatment Strategies

Participants agreed that there are no uniformly agreed upon diagnostic or treatment protocols for chronic nonbacterial prostatitis/CPPS, and no one knows to what extent the diagnostic findings in this disorder, i.e., white blood cells in prostatic secretions, occur in asymptomatic men.

Recommendations

1. Establish treatment and diagnostic protocols based on scientific data and a hypothesis for the pathophysiology of chronic nonbacterial prostatitis/CPPS.
2. Establish the necessity for EPS, seminal fluid, and VB3 evaluation and relationships, if any, to treatment/outcome.
3. Establish the relationship between white cells in the semen and the symptoms of chronic nonbacterial prostatitis/CPPS.
4. Establish the benefits and efficacy of currently utilized diagnostic tests and therapeutic strategies.
5. Establish the effectiveness of empiric antibiotic and other forms of therapy for chronic nonbacterial prostatitis/CPPS.

Current Research and Future Needs

There are few controlled scientific or clinical studies on chronic nonbacterial prostatitis/CPPS.

Recommendations

If progress is to be made in the treatment, diagnosis, and prevention of chronic nonbacterial prostatitis/CPPS, research studies must focus on:

1. The immune and immunological mechanisms of the prostate and urethra.
2. Bacterial growth and the prostate.
3. The relationship between prostate inflammation and bladder irritation, and pain and sensory mechanisms in the prostate, bladder, and surrounding pelvic tissues.
4. Clinical and basic research studies must be based on a valid, testable hypotheses and utilize adequate, well-defined controls.
5. A standardized protocol for therapeutic intervention trials must be established to which all future clinical research studies will comply so that data from diverse studies can be compared.
6. Animal models can provide useful, essential information in many of the basic research areas, but before the findings can be translated to human disease, there must be a greater understanding of the pathological changes occurring in the human prostate chronic nonbacterial prostatitis/CPPS (e.g., what is the type and extent of inflammation in symptomatic and asymptomatic diseases).

Epidemiologic and Health Care Cost Data

There are no reliable data on either the epidemiology, natural history, effectiveness of treatment, or health care costs for chronic nonbacterial prostatitis/CPPS.

Recommendations

1. The highest priority is the development and validation of a population-based symptom index.
2. Survey research must be initiated to further define the epidemiology of chronic nonbacterial prostatitis/CPPS, especially the distribution of the disease in minority populations.
3. Research studies must be initiated to identify what, if any, long-term morbidity is associated with chronic nonbacterial prostatitis/CPPS and to identify any association with other diseases of the prostate.

Summary

Chronic nonbacterial prostatitis/CPPS needs extensive clinical and basic research studies if progress is to be made toward diagnosis, treatment, and prevention. Workshop participants identified the following items as crucial:

1. Validate the working definition and diagnostic criteria.
2. Develop and validate a symptom index.
3. Validate clinical and laboratory studies needed for diagnosis and treatment followup, including time interval for followup studies.
4. Develop a valid diagnostic protocol and correlate it with objective, measurable parameters.
5. Establish a database for a longitudinal study of treated and untreated disease.
6. Develop a protocol for multi-center, long-term, therapeutic trials.
7. Encourage and support basic and clinical research in the pathophysiology of the disease process.

Workshop participants strongly encouraged the NIDDK to hold biannual clinical and scientific workshops focusing on chronic nonbacterial prostatitis/CPPS. These workshops should review scientific progress, develop a collaborative network of investigators and clinicians, and attract new and experienced investigators from related research areas.

Working Groups and Chairs

Research and Clinical Definitions
John N. Krieger, M.D.
University of Washington, Seattle

Diagnostic Evaluation and Treatment Strategies
Anthony J. Schaeffer, M.D.
Northwestern University, Chicago

Current Research and Future Needs
John W. Warren, M.D.
University of Maryland, Baltimore

Epidemiologic and Health Care Cost Data
Mark Litwin, M.D., M.P.H.
University of California, Los Angeles

Speakers

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17 March 1998