Chronic Pelvic PainNCT05185180
Effects of Epigenetic Regulation in Chronic Pelvic Pain Syndrome
An observational study of Chronic Pelvic Pain, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years, men only
- Conditions the study is for
- Chronic Pelvic Pain
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2021to 7 Mar 2023
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- Men only
- Adult, Older adult
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.
Who may be able to join
- Healthy males ages 21-80 years old
Who cannot join
- Females
- Males <21 and >80 years old
- Patients with impaired renal or hepatic function.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
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.
Read the detailed description
CPPS is a condition that is estimated to affect up to 15% of the male population with most diagnoses between the ages of 35-45. Designated by the presence of pain in the absence of bacterial infection for more than three months, it has unknown, probably complex etiology, which thus far have hampered efforts to determine effective treatment strategies. The heterogeneous nature of the symptoms and the length of the disease course prior to detection, presentation or diagnosis only further exacerbate these issues. 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. This is conceptually a major advance - as a variety of factors including early life stress events, prostate infectious agents, environmental variables, all could contribute to epigenetic change and may therefore explain both the anecdotal etiologies described in this syndrome as well as the difficulty in pinpointing a precise etiological mechanism. Specifically, our data leads us to hypothesize that epigenetic alterations in regulatory and proinflammatory immune pathways underpin the development of chronic pelvic pain in CPPS. In this study, we propose to validate our preliminary findings in a larger set of CP/CPPS patients and controls as well as utilize murine models of prostatitis to understand the mechanism driving altered IL-10 and IL-7/LFA-1 mediated immune responses both at systemic and prostate levels. If epigenetic defects and functional deficits can be demonstrated, diagnosis and treatment methodologies could be better targeted at correction of these chronic deficits rather than at etiological agents/pathways that are in the past.
BACKGROUND:
Prostatitis accounts for approximately 2 million outpatient visits per year in the United States, including 1% of those to primary care physicians. Chronic pelvic pain syndrome (CPPS) accounts for 90% of all chronic prostatitis but has no well-defined etiology. It is clinically characterized by the symptoms of pain in the perineum, testes, penis, suprapubic area, dysuria and profound reductions in patient quality of life. Epidemiologic observations indicate that prostatitis conditions are the most frequent urologic diagnosis in young men and the third most frequent urologic diagnosis in men older than 50 yr, representing 8-12% of urology office visits. The NIH consensus definition and classification identifies four categories of prostatitis. Categories I and II have bacterial etiologies while the rest are believed to be non- bacterial in etiology.
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.
- Conditions
- Chronic Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifying Immune-related Epigenetic Modifications
Percent of methylation of genes involved in inflammation and regulation
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start11 Oct 2021
- Primary completion7 Mar 2023
- Study completion7 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Pelvic PainStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Praveen Thumbikat, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185180
- Sponsor's protocol ID
- STU00215831
- Status last verified
- Aug 2026
- First submitted
- 5 Nov 2021
- Last updated
- 28 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Epigenetic Regulation in Chronic Pelvic Pain Syndrome
- ClinicalTrials.gov ID
- NCT05185180
- Acronym / sponsor ID
- STU00215831
- Conditions
- Chronic Pelvic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 7 Mar 2023 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Posted 28 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
CPPS is a condition that is estimated to affect up to 15% of the male population with most diagnoses between the ages of 35-45. Designated by the presence of pain in the absence of bacterial infection for more than three months, it has unknown, probably complex etiology, which thus far have hampered efforts to determine effective treatment strategies. The heterogeneous nature of the symptoms and the length of the disease course prior to detection, presentation or diagnosis only further exacerbate these issues. 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. This is conceptually a major advance - as a variety of factors including early life stress events, prostate infectious agents, environmental variables, all could contribute to epigenetic change and may therefore explain both the anecdotal etiologies described in this syndrome as well as the difficulty in pinpointing a precise etiological mechanism. Specifically, our data leads us to hypothesize that epigenetic alterations in regulatory and proinflammatory immune pathways underpin the development of chronic pelvic pain in CPPS. In this study, we propose to validate our preliminary findings in a larger set of CP/CPPS patients and controls as well as utilize murine models of prostatitis to understand the mechanism driving altered IL-10 and IL-7/LFA-1 mediated immune responses both at systemic and prostate levels. If epigenetic defects and functional deficits can be demonstrated, diagnosis and treatment methodologies could be better targeted at correction of these chronic deficits rather than at etiological agents/pathways that are in the past.
BACKGROUND:
Prostatitis accounts for approximately 2 million outpatient visits per year in the United States, including 1% of those to primary care physicians. Chronic pelvic pain syndrome (CPPS) accounts for 90% of all chronic prostatitis but has no well-defined etiology. It is clinically characterized by the symptoms of pain in the perineum, testes, penis, suprapubic area, dysuria and profound reductions in patient quality of life. Epidemiologic observations indicate that prostatitis conditions are the most frequent urologic diagnosis in young men and the third most frequent urologic diagnosis in men older than 50 yr, representing 8-12% of urology office visits. The NIH consensus definition and classification identifies four categories of prostatitis. Categories I and II have bacterial etiologies while the rest are believed to be non- bacterial in etiology.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Healthy males ages 21-80 years old
Key exclusion criteria (3 listed)
- Females
- Males <21 and >80 years old
- Patients with impaired renal or hepatic function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identifying Immune-related Epigenetic Modifications
Time frame: 1 hour
Percent of methylation of genes involved in inflammation and regulation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Praveen Thumbikat, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pelvic Pain, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identifying Immune-related Epigenetic Modifications (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.