Clinical trial NCT03027076: Microbiome of Urologic Chronic Pelvic Pain Syndrome
Official title: Microbiome Studies of Urologic Chronic Pelvic Pain Syndrome
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Prostatitis
Chronic Prostatitis
Interstitial Cystitis
Painful Bladder Syndrome
Bladder Pain Syndrome
Keywords: prostatitis
chronic prostatitis
chronic pelvic pain syndrome
interstitial cystitis
painful bladder syndrome
bladder pain syndrome
biomarkers
biological markers
bacteria
microbiome
inflammation
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2017-01-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Community Sample

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.

Eligibility criteria: 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 exclusion criteria:

In addition to the exclusion criteria listed above, additional criteria for control subjects are as follows:

* Chronic Pain: In the past year, symptoms of discomfort or pain in the pelvic region for a period longer than 3 months within the preceding year;
* Infection: Volunteers who have had a urinary tract infection with a urine culture value of \>100,000 colony forming units/ml (CFU/ml) within the past three months.
* Intravesical Therapy: Volunteers treated with intravesical chemotherapy or Bacillus Calmette-Guerin (BCG) therapy;
* Gastrointestinal Conditions: Volunteers with inflammatory bowel disease (such as Crohn's disease or ulcerative colitis, but not irritable bowel syndrome).

Primary outcomes:
measure: Microbiome
timeFrame: Within 6 month period from baseline evaluation
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Arthur L Burnett, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: