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Chemokine Mechanisms in Chronic Pelvic Pain

This study is currently recruiting participants.
Verified April 2013 by Northwestern University
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Praveen Thumbikat, Northwestern University
ClinicalTrials.gov Identifier:
NCT01676857
First received: August 29, 2012
Last updated: April 3, 2013
Last verified: April 2013
History of Changes
  Purpose

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


Condition
Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Prostatitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chemokine Mechanisms in Chronic Pelvic Pain

Resource links provided by NLM:

MedlinePlus related topics: Pelvic Pain
U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Correlation of cytokines/chemokines/proteins with CPPS symptoms [ Time Frame: Over the period of a year ] [ Designated as safety issue: No ]
    Cytokines/chemokines/proteins will be correlated with symptom scores from patients in a longitudinal fashion.


Biospecimen Retention:   Samples With DNA

Expressed prostatic secretions, urine with or without cells, blood for cells and plasma


Estimated Enrollment: 264
Study Start Date: May 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676857

Contacts
Contact: Darlene Marko, RN 3126953898 d-marko@northwestern.edu
Contact: Praveen Thumbikat, PhD 3125031050 thumbikat@northwestern.edu

Locations
United States, Illinois
Northwestern Medical Faculty Foundation Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Praveen Thumbikat, PhD            
Sponsors and Collaborators
Northwestern University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Praveen Thumbikat, PhD Northwestern University
  More Information

Publications:

Responsible Party: Praveen Thumbikat, Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01676857     History of Changes
Other Study ID Numbers: STU00030121, R01DK083609
Study First Received: August 29, 2012
Last Updated: April 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
chronic pain, prostatitis, pelvic pain

Additional relevant MeSH terms:
Pelvic Pain
Prostatitis
Chronic Disease
Pain
Signs and Symptoms
 Prostatic Diseases
Genital Diseases, Male
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013