Chemokine Mechanisms in Chronic Pelvic Pain

Prostatitis Clinical Trial

Official title:

Chemokine Mechanisms in Chronic Pelvic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01676857
• Other study ID #: STU00030121
• Secondary ID: R01DK083609R01DK
• Status: Completed
• Start date: May 2010
• Est. completion date: January 24, 2019

Study information

• Verified date: March 2019
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: January 24, 2019
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Prostatitis With Chronic Pelvic Pain Syndrome
• Pelvic Pain
• Prostatitis

Locations

Country	Name	City	State
United States	Northwestern Medical Faculty Foundation	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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