Chemokine Mechanisms in Chronic Pelvic Pain



Status:Completed
Conditions:Chronic Pain, Women's Studies
Therapuetic Areas:Musculoskeletal, Reproductive
Healthy:No
Age Range:18 - Any
Updated:3/15/2019
Start Date:May 2010
End Date:January 24, 2019

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

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.

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)
We found this trial at
1
site
Chicago, Illinois 60611
Principal Investigator: Praveen Thumbikat, PhD
?
mi
from
Chicago, IL
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