Trial Outcomes & Findings for Effects of Epigenetic Regulation in Chronic Pelvic Pain Syndrome (NCT NCT05185180)
NCT ID: NCT05185180
Last Updated: 2026-08-28
Results Overview
Percent of methylation of genes involved in inflammation and regulation
Recruitment status
COMPLETED
Target enrollment
11 participants
Primary outcome timeframe
1 hour
Results posted on
2026-08-28
Participant Flow
Participant milestones
| Measure |
Males With Category III Chronic Pelvic Pain Syndrome
Men with Category III CPPS 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.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
|
Overall Study
COMPLETED
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Epigenetic Regulation in Chronic Pelvic Pain Syndrome
Baseline characteristics by cohort
| Measure |
Males With Category III Chronic Pelvic Pain Syndrome
n=6 Participants
* Male ages 21-80 years old
* Diagnosed with Category III Chronic Pelvic Pain Syndrome
* Patients reporting pain or discomfort in any of the 8 domains of the NIH Chronic Prostatitis Symptom Index (NIH-CPSI).
* CP/CPPS symptoms must have been present for the majority of the time during any 3 months in the previous 6 months.
|
Control Group
n=5 Participants
• Healthy males ages 21-80 years old
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=31 Participants
|
5 Participants
n=49 Participants
|
10 Participants
n=80 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
1 Participants
n=80 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=31 Participants
|
5 Participants
n=49 Participants
|
11 Participants
n=80 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=31 Participants
|
2 Participants
n=49 Participants
|
4 Participants
n=80 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=31 Participants
|
3 Participants
n=49 Participants
|
7 Participants
n=80 Participants
|
PRIMARY outcome
Timeframe: 1 hourPercent of methylation of genes involved in inflammation and regulation
Outcome measures
| Measure |
Males With Category III Chronic Pelvic Pain Syndrome
n=6 Participants
* Male ages 21-80 years old
* Diagnosed with Category III Chronic Pelvic Pain Syndrome
* Patients reporting pain or discomfort in any of the 8 domains of the NIH Chronic Prostatitis Symptom Index (NIH-CPSI).
* CP/CPPS symptoms must have been present for the majority of the time during any 3 months in the previous 6 months.
|
Control Group
n=5 Participants
• Healthy males ages 21-80 years old
|
|---|---|---|
|
Identifying Immune-related Epigenetic Modifications
|
91.767 Percent methylation of IL10 (cpg 387)
Standard Deviation 2.190
|
85.835 Percent methylation of IL10 (cpg 387)
Standard Deviation 8.672
|
Adverse Events
Males With Category III Chronic Pelvic Pain Syndrome
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place