Completed

Chemokine Mechanisms in Chronic Pelvic Pain

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What is being collected

Data Collection

Collected from today forward - Prospective
DNA Samples
Who is being recruted

Urogenital Diseases+9

+ Genital Diseases

+ Genital Diseases, Male

Over 18 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: May 2010
See protocol details

Summary

Principal SponsorNorthwestern University
Last updated: March 13, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2010

Actual date on which the first participant was enrolled.

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.

NCT01676857
Principal SponsorNorthwestern University
Last updated: March 13, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

147 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleNeurologic ManifestationsPainProstatic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMale Urogenital DiseasesProstatitisPelvic PainChronic Pain

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. 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)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Northwestern Medical Faculty Foundation

Chicago, United StatesOpen Northwestern Medical Faculty Foundation in Google Maps
CompletedOne Study Center