Chemokine Mechanisms in Chronic Pelvic Pain

The purpose of this study is to identify biomarkers that can be utilized in the diagnosis of chronic pelvic pain syndrome in men.

Study Overview

• Status: Completed
• Conditions: Prostatitis; Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Detailed Description

Chronic pelvic pain is the hallmark of patients with chronic pelvic pain syndrome (CPPS), a non-bacterial category of prostatitis that is a significant source of morbidity in American men. The cause of CPPS is unknown and there is a lack of convenient biomarkers for diagnosis of this syndrome. This project will examine the expression of biomarkers in expressed prostatic fluid from adult men with and without a diagnosis of CPPS. Thus our specific aim is to validate the use of the chemokines MCP-1 and MIP-1alpha and mast cell tryptase as biomarkers for CPPS in humans and correlate their levels with CPPS symptoms.

• Study Type: Observational
• Enrollment (Actual): 147

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medical Faculty Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

The Study population will include 176 adult patients diagnosed with CPPS (equal numbers of CPPS IIIa and CPPS IIIb) and 88 adult comparator controls, at least 18 years of age, recruited from Northwestern urology clinical site practices. All CPPS participants will be male and will have pelvic pain symptoms. Men who are at least 18 years of age and who had been seen by a physician for symptoms of CP/CPPS within the previous 2 years will comprise the patient population.

Description

Inclusion Criteria:

• CP/CPPS group inclusion criteria

Patients are eligible for the study if they meet the following criteria:

• Participant has signed and dated the appropriate Informed Consent document.
• Agreed to participate in Study procedures.
• Participant is at least 18 years of age.
• Participant reports a response of at least 1 on the pain, pressure or discomfort scale (SYM-Q, Question #1).
• Participant reports pain or discomfort in any of the 8 domains of the Male Genitourinary Pain Index (MGUPI) (items 1a, 1b, 1c, 1d, 2a, 2b, 2c, 2d).
• These CP/CPPS symptoms been present for the majority of the time during any 3 months in the previous 6 months.

Exclusion Criteria:

• Participant has an on-going symptomatic urethral stricture.
• Participant has an on-going neurological disease or disorder affecting the bladder or bowel fistula.

Participant has a history of cystitis caused by tuberculosis, radiation therapy or Cytoxan/cyclophosphamide therapy.

• Participant has augmentation cystoplasty or cystectomy.
• Participant has a history of cancer (with the exception of skin cancer).
• Participant has current major psychiatric disorder or other psychiatric or medical issues that would interfere with study participation (e.g. dementia, psychosis, upcoming major surgery, etc).
• Participant diagnosed with unilateral orchialgia, without pelvic symptoms.
• Participant has a history of transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), balloon dilation, prostate cryo-surgery, or laser procedure.

Control group exclusion criteria In addition to the exclusion criteria listed above additional criteria for control subjects are as follows.

1. In the past year, symptoms of discomfort or pain in the pelvic region for extended periods of time.
2. Volunteers who have had a urinary tract infection with a urine culture value of >100,000 CFU/ml within the past three months.
3. Volunteers treated with intravesical chemotherapy or BCG.
4. Volunteers who have had any of the following sexually transmitted diseases (STDs) - gonorrhea, chlamydia, mycoplasma or trichomonas.
5. Volunteers with inflammatory bowel disease (such as Crohn's disease or ulcerative colitis, but not irritable bowel syndrome)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
CP/CPPS group; The Study population will include patients diagnosed with CPPS (equal numbers of CPPS IIIa and CPPS IIIb) at least 18 years of age, recruited from Northwestern urology clinical site practices. All CPPS participants will be male and will have pelvic pain symptoms. Men who are at least 18 years of age and who had been seen by a physician for symptoms of CP/CPPS within the previous 2 years will comprise the patient population
Control group; Adult male volunteers who are male, at least 18 years of age and meet inclusion and exclusion criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of cytokines/chemokines/proteins with CPPS symptoms	Cytokines/chemokines/proteins will be correlated with symptom scores from patients in a longitudinal fashion.	Over the period of a year

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Praveen Thumbikat, PhD, Northwestern University

Publications and helpful links

General Publications

• Desireddi NV, Campbell PL, Stern JA, Sobkoviak R, Chuai S, Shahrara S, Thumbikat P, Pope RM, Landis JR, Koch AE, Schaeffer AJ. Monocyte chemoattractant protein-1 and macrophage inflammatory protein-1alpha as possible biomarkers for the chronic pelvic pain syndrome. J Urol. 2008 May;179(5):1857-61; discussion 1861-2. doi: 10.1016/j.juro.2008.01.028. Epub 2008 Mar 18.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): January 31, 2018
• Study Completion (Actual): January 24, 2019

Study Registration Dates

• First Submitted: August 29, 2012
• First Submitted That Met QC Criteria: August 29, 2012
• First Posted (Estimate): August 31, 2012

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 11, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: chronic pain, prostatitis, pelvic pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Prostatic Diseases; Pelvic Pain; Prostatitis
• Other Study ID Numbers: STU00030121; R01DK083609 (U.S. NIH Grant/Contract); R01DK094898 (U.S. NIH Grant/Contract)