Trans-MAPP II Study of Urologic Chronic Pelvin Pain

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.
• •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.
• •Participant has a positive Urine pregnancy test.
• •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.
• •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.