Effects of Epigenetic Regulation in Chronic Pelvic Pain Syndrome

NCT05185180 | Active Not Recruiting

• 1 other identifier: STU00215831
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to identify defects in immune activation or regulation that may affect a subset of patients with CP/CPPS. This subset appears to have a reduced ability to mount a regulatory immune response, while simultaneously eliciting an exaggerated activated immune response. The defects that we demonstrate appear to be linked to altered methylation of genes involved in both immune regulation and immune activation. The aims of this study will provide definitive evidence of a role for epigenetic changes in immune cells in patients with CP/CPPS.

Conditions

Chronic Pelvic Pain

Outcome Measures

Primary Outcomes (3)

• Identifying immune-related epigenetic modifications in patients with CP/CPPS.

  To recruit CP/CPPS patients and healthy volunteers to obtain peripheral blood and prostate secretions (EPS) for performing epigenetic analysis of PBMC

  5 Years

• Identifying immune-related modifications in patients with CP/CPPS.

  To recruit CP/CPPS patients and healthy volunteers to obtain peripheral blood and prostate secretions (EPS) for examination of immune changes.

  5 Years

• Identifying patient symptoms in CP/CPPS.

  To recruit CP/CPPS patients and healthy volunteers to obtain peripheral blood and prostate secretions (EPS) for examining correlation with patient symptoms.

  5 Years

Study Arms (2)

Males with Category III Chronic Pelvic Pain Syndrome

Category III is subdivided into inflammatory (IIIa) and noninflammatory (IIIb) subtypes, based on the presence of white blood cells in expressed prostatic secretions (EPS). Category III prostatitis or chronic pelvic pain syndrome (CPPS) is the most common prostatitis observed in medical practice with a prevalence rate in the general population from 5% to 14.2%. CPPS is a poorly understood entity characterized by pelvic or perineal pain, irritative voiding symptoms, and sexual dysfunction.

Control Group

The control group will consist of men with no history of Chronic Pelvic Pain or any underlying condition.

Eligibility Criteria

• Age: 21 Years - 80 Years
• Gender Eligibility Details: Recruiting healthy males with no history of chronic pelvic pain or no underlying conditions to be the control group for effects of epigenetic regulation in chronic pelvic pain syndrome
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We hypothesize that aberrant immune regulation and/or activation due to epigenetic alterations in immune genes facilitate chronic pelvic pain. The objective of this aim is to expand on our preliminary data demonstrating epigenetic modifications in immune-related genes in CP/CPPS patients compared to healthy controls. To do so, we propose to recruit CP/CPPS patients and healthy volunteers to obtain peripheral blood and prostate secretions (EPS) for performing tailored methylation arrays on PBMC's, examination of functional consequences of immune alterations and finally correlation with patient symptoms.

You may qualify if:

• Healthy males ages 21-80 years old

You may not qualify if:

• Females
• Males \<21 and \>80 years old
• Patients with impaired renal or hepatic function.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

* Undergo specimen collection of: * Void Bladder 1, 2, and 3 (10mL of urine, each; 30mL total) * Expressed prostatic secretion (EPS) * Peripheral blood (3 tubes, 10mL each) * Complete baseline questionnaires * National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) * American Urological Symptom Index (AUA-SI) * A Physical examination including vital heart rate, breathing rate, blood pressure, temperature, height, weight and body mass will be taken * Provide a basic health history, including current general health, adverse events, medications or treatments within the past 5 years.

Study Officials

• Praveen Thumbikat, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: O'Connor Family Research Professor of Urology

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: January 11, 2022
• Study Start: October 11, 2021
• Primary Completion: June 1, 2025
• Study Completion: December 11, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-12

Locations

US (1)