Skip to content

Microbiome of Urologic Chronic Pelvic Pain Syndrome

Microbiome Studies of Urologic Chronic Pelvic Pain Syndrome

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03027076
Enrollment
0
Registered
2017-01-20
Start date
2013-11-30
Completion date
2015-01-31
Last updated
2017-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Pain Syndrome, Chronic Prostatitis, Interstitial Cystitis, Painful Bladder Syndrome, Prostatitis

Keywords

prostatitis, chronic prostatitis, chronic pelvic pain syndrome, interstitial cystitis, painful bladder syndrome, bladder pain syndrome, biomarkers, biological markers, bacteria, microbiome, inflammation

Brief summary

This research is being done to learn more about the bacteria that live in the genito-urinary tract in subjects with urologic chronic pelvic pain syndrome (UCPPS).

Detailed description

This research is being done to learn more about the bacteria that live in the genito-urinary tract in subjects with urologic chronic pelvic pain syndrome (UCPPS). A microbiome is defined as the ecological community of commensal, symbiotic, and pathogenic microorganisms that literally share our body space. (Lederberg, 2001) The present study is designed to establish the prostate, urinary bladder and urethral microbiome in men with chronic prostatitis/chronic pelvic pain syndrome or the urinary bladder and urethral microbiome in women with interstitial cystitis/painful bladder syndrome. The human urethra, bladder and prostate normally harbor microbial communities. The recent advent of large-scale omics technologies allows a detailed analysis of those communities. While current knowledge of the normal inhabitants of the human urogenital tract remains incomplete, more than 90% of patients with UCPPS report the onset of symptoms following a urinary tract infection. The causative agents in most of those cases remain unknown, partly due to the limitations of older detection technologies that require the detection and isolation of a single microorganism for implicating it as a causative agent. Furthermore, many microbial species remain unculturable and therefore, are often undetectable using standard technology. The current project will utilize state-of-the-art omic technology to detect and identify microbial species in the urethra and bladder of both men and women and the prostate of men. Additionally, the inflammatory response that accompanies those microbial communities will be characterized. Finally, the presence and number of microbial species will be correlated with the intensity of the inflammatory response and the severity of symptoms that patients with UCPPS experience.

Interventions

PROCEDUREGenitourinary Specimen Collection

Collect urethral swab, urine before prostatic massage (pre-M), urine after prostatic massage (post-M) and Expressed Prostatic Secretion (EPS)

PROCEDURECollect midstream urine samples

Collect midstream urine samples

Sponsors

Johns Hopkins University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Consent: Participant has signed and dated the Informed Consent document, approved by the Johns Hopkins Medical Institutions Institutional Review Board; * Agreement: Participant agrees to participate in study procedures; * Age: Participant is at least 18 years of age; * Symptom Severity: Participant reports a response of at least 8 on the Pain Domain of the NIH-Chronic Prostatitis Symptom Index (CPSI) Questionnaire; * Duration of Symptoms: Symptoms have been present for at least 3 months within the preceding 6 months.

Exclusion criteria

* Urethral conditions: Participant has an ongoing symptomatic urethral stricture; * Bladder conditions: Participant has a history of cystitis caused by tuberculosis, radiation therapy or cytoxan/cyclophosphamide therapy, augmentation cystoplasty or cystectomy; * Testicular conditions: Participant diagnosed with unilateral orchialgia, without pelvic symptoms; * Prostate conditions or procedures: Participant has a history of transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), balloon dilation, prostate cryosurgery, or laser procedure; * Neurological diseases or disorders affecting the bladder: Parkinson disease, multiple system atrophy, multiple sclerosis, spinal cord injury, cervical myelopathy, acute transverse myelitis, diabetic cystopathy, or dysfunctional voiding (non-neurogenic neurogenic bladder or Hinman syndrome); * Psychiatric conditions: 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.); * Malignancy: Participant has a history of cancer (with the exception of skin cancer). Control group

Design outcomes

Primary

MeasureTime frameDescription
MicrobiomeWithin 6 month period from baseline evaluationEvaluate the microbiome at baseline, one good day (minimal or no symptoms) and one bad day (worst symptoms) within a 6 month period

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026