Microbiome of Urologic Chronic Pelvic Pain Syndrome
Microbiome of Urologic Chronic Pelvic Pain Syndrome
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).
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.
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).