Trans-MAPP II Study of Urologic Chronic Pelvin Pain

Urological Chronic Pelvic Pain Syndromes (UCPPS) are characterized by pelvic pain with
concurrent urinary symptoms. Broadly, UCPPS comprise Interstitial Cystitis/Painful Bladder
SyndromeBladder Pain Syndrome (IC/BPS) in men and women, and Chronic Prostatitis/Chronic
Pelvic Pain Syndrome (CP/CPPS) in men. IC is a debilitating bladder disorder characterized by
urinary urgency, frequency, and pain. The presentation of symptoms can be quite variable
among patients, suggesting that IC is a multi-factorial syndrome with several proposed
etiologies, some of which may be interrelated.1 BPS as defined by the International
Continence Society, is "the complaint of suprapubic pain related to bladder filling,
accompanied by other symptoms, such as increased daytime and night-time frequency, in the
absence of proven urinary infection or other obvious pathology."2 BPS is a clinical
description of disease based on the patient's symptoms, and does not depend on urodynamic or
cystoscopic findings. These symptoms may be related to IC, although diagnostic criteria are
still lacking for this entity, and the relationship between BPS and IC is not clear. After
the initiation phase for the MAPP SPS Study, it became clear that many of the hypotheses
being proposed required well-characterized healthy "normal" controls that lack urologic pain
as well as other study related symptoms/conditions. This second phase is enriched with
pre-defined subgroups and a longer follow-up period which will allow further investigation of
clinical and biologic factors associated with worsening and/or improvement of reported
urinary and non-urinary symptoms.

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.