Chemokine Mechanisms in Chronic Pelvic Pain
Data Collection
Collected from today forward - ProspectiveUrogenital Diseases+9
+ Genital Diseases
+ Genital Diseases, Male
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.147 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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.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