Eligibility Details:
Inclusion Criteria:
- Participant has signed and dated the appropriate Informed Consent document.
- Agreed to participate in ALL required study procedures (including Biospecimen
collections, Neuroimaging, and Quantitative Sensory Testing).
- Gave permission for use of DNA for genetics studies.
- Gender recorded in Participant Registration module.
- Participant is at least 18 years of age.
- Participant is able to speak, read, and understand English.
- Participant reports a response of "0" (zero) on the pain, pressure or discomfort scale
(SYM-Q, Question #1).
- Participant reports no chronic pain in the pelvic or bladder region, and reports no
chronic pain in any other body region.
- Participant reports no urological symptoms that have been evaluated, but are still
present.
Exclusion Criteria:
- Participant has an on-going symptomatic urethral stricture.
- Participant has an on-going neurological disease or disorder affecting the bladder or
bowel fistula.
- Participant has a history of cystitis caused by tuberculosis, radiation therapy or
Cytoxan/cyclophosphamide therapy.
- Participant has augmentation cystoplasty or cystectomy.
- Participant has an active autoimmune or infectious disorder (such as Crohn's Disease
or Ulcerative Colitis, Lupus, Rheumatoid Arthritis, Multiple Sclerosis, or HIV).
- Participant has a history of cancer (with the exception of skin cancer).
- 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.).
- Participant has severe cardiac, pulmonary, renal, or hepatic disease that in the
judgment of the study physician would preclude participation in this study.
- Participant has had definitive treatment for acute epididymitis, urethritis,
vaginitis.
- Participant has history of unevaluated hematuria, this will require the evaluation of
a study physician to determine if this has been appropriately evaluated.
- Participant has had a cystoscopy with hydrodistention or kenalog injection.
Exclusion Criteria for Males Only:
- Diagnosis of unilateral orchalgia, without pelvic symptoms.
- History of transurethral microwave thermotherapy (TUMT), transurethral needle ablation
(TUNA), balloon dilation, prostate cryo-surgery, or laser procedure.
- A prostate biopsy or transurethral resection of the prostate (TURP) within the last
three months.
Exclusion Criteria for Females Only:
• Participant has a positive Urine pregnancy test.
Specimen Exclusion Criteria (Males and Females):
• Participant has a positive dipsticParticipant has a positive urine culture.
Fatigue Symptom Eligibility Criteria:
- Participant, for at least 3 months in the past year, has persistent fatigue not
relieved with rest.
- Participant, for at least 3 months in the past year, has extreme fatigue following
exercise or mild exertion.
- Participant, for at least 3 months in the past year, has impaired memory,
concentration or attention.
Exclusion Criteria - Urine test results:
A clean-catch midstream urine specimen (VB2) will be obtained from all male and female
participants during the initial and 6 month study visits, so that a urine dipstick analysis
can be done for all participants, and a urine pregnancy test can be conducted for females
of child bearing age excluding those who are post-menopausal and those with a history of
hysterectomy.
- If participant has an abnormal dipstick urinalysis indicating abnormal levels of
nitrites and/or occult blood, that in the opinion of the Principal Investigator
warrants exclusion, participant will be ineligible for study participation at the
initial visit and withdrawn from study participation. A positive dipstick at the 6
Month visit will also result in the participant being withdrawn.
- If participant has had a positive urine culture in the past 6 weeks, or currently has
a midstream urine culture (VB2) (>100,000 CFU/ml), with a single uropathogen, the
participant will be ineligible for the study at the initial visit, treated and
withdrawn from study participation. A positive dipstick at the 6 Month visit will also
result in the participant being treated and withdrawn. (Must be documented on Urine
Culture Result - UCR form). We will keep all specimens and data collected from both
eligible and in-eligible participants unless participant request that his/her data be
destroyed, and not utilized for the study.
common.study.methods.has-drugs-no
common.study.methods.is-healthy-no
