Are you healthy and looking to help advance medical science?

You may be eligible to participate in a chronic prostatitis with chronic pelvic pain syndrome clinical study, and could be compensated for your time.

Are you healthy and looking to help advance medical science? You may be eligible to participate in a chronic prostatitis with chronic pelvic pain syndrome clinical study, and could be compensated for your time.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Chronic Prostatitis With Chronic Pelvic Pain Syndrome Clinical Trial in Chicago IL

NCT01676857 | Observational

Are you healthy and looking to help advance medical science?

You may be eligible to participate in a chronic prostatitis with chronic pelvic pain syndrome clinical study, and could be compensated for your time.

Completed

Male

18 Years +

This study has recruited 147 Participants

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

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Details for the 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.

Brief Title

Chemokine Mechanisms in Chronic Pelvic Pain

Official Title

Chemokine Mechanisms in Chronic Pelvic Pain

Brief Summary

The purpose of this study is to identify biomarkers that can be utilized in the diagnosis of<br /> 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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

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

Study 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)