Chemokine Mechanisms in Chronic Pelvic Pain

NCT01676857 | Completed

• 3 other identifiers: STU00030121R01DK083609R01DK094898
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Prostatitis With Chronic Pelvic Pain Syndrome; Prostatitis

Keywords

chronic pain, prostatitis, pelvic pain

Outcome Measures

Primary Outcomes (1)

• 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 Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• In the past year, symptoms of discomfort or pain in the pelvic region for extended periods of time.
• Volunteers who have had a urinary tract infection with a urine culture value of \>100,000 CFU/ml within the past three months.
• Volunteers treated with intravesical chemotherapy or BCG.
• Volunteers who have had any of the following sexually transmitted diseases (STDs) - gonorrhea, chlamydia, mycoplasma or trichomonas.
• Volunteers with inflammatory bowel disease (such as Crohn's disease or ulcerative colitis, but not irritable bowel syndrome)

Sponsors & Collaborators

• Northwestern University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Northwestern Medical Faculty Foundation

Chicago, Illinois, 60611, United States

Location

Related 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.

  PMID: 18353390 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Prostatitis; Chronic Pain; Pelvic Pain

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Praveen Thumbikat, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 29, 2012
• First Posted: August 31, 2012
• Study Start: May 1, 2010
• Primary Completion: January 31, 2018
• Study Completion: January 24, 2019
• Last Updated: March 13, 2019

Record last verified: 2019-03

Locations

US (1)