Chemokine Mechanisms in Chronic Pelvic Pain

NCT ID: NCT01676857

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 147 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2019-01-24

Brief Summary

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

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.

Conditions

Chronic Prostatitis With Chronic Pelvic Pain Syndrome; Prostatitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Control group

Adult male volunteers who are male, at least 18 years of age and meet inclusion and exclusion criteria

No interventions assigned to this group

Eligibility Criteria

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.

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Praveen Thumbikat

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Praveen Thumbikat, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern Medical Faculty Foundation

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 18353390 (View on PubMed)

Other Identifiers

R01DK083609

Identifier Type: NIH

Identifier Source: secondary_id

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R01DK094898

Identifier Type: NIH

Identifier Source: secondary_id

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STU00030121

Identifier Type: -

Identifier Source: org_study_id