Observational Study of Control Participants for the MAPP Research Network

Conditions:Fibromyalgia, Irritable Bowel Syndrome (IBS), Neurology, Pain
Therapuetic Areas:Gastroenterology, Musculoskeletal, Neurology, Rheumatology
Age Range:18 - Any
Start Date:December 2009
Contact:Nancy Robinson, PhD

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Multidisciplinary Approach to the Study of Chronic Pelvic Pain: Trans-MAPP Control Study

The Control Study for the Multidisciplinary Approach to the Study of Chronic Pelvic Pain
(MAPP) Research Network has been established to focus on a broader approach to the study of
Interstitial Cystitis (IC)/Painful Bladder Syndrome (PBS) in men and women, and Chronic
Prostatitis (CP)/Chronic Pelvic Pain Syndrome (CPPS) in men, than previously undertaken.

Participants with no Urologic Pelvic Pain Syndromes as well as participants with specific
conditions (Fibromyalgia (FM), Irritable Bowel Syndrome (IBS), Chronic Fatigue Syndrome
(CFS)) are being recruited for the Trans-MAPP Control Study. These participants will act as
a reference/control group for the Trans-MAPP Epidemiology & Phenotyping (EP) Study.

As with many chronic pain disorders, IC and CP are poorly understood, and treatment is often
not helpful. The goal of this study is to better understand how pain is felt in people with
IC or CP. The MAPP Control Study is an observational study that will enroll participants
from 6 Discovery Sites and 3 Satellite Sites across the U.S. The investigators will ask
questions and gather information about the health and life of the participants for research
purposes. The investigators hope that this study will lead to improvement in the treatment
of IC and CP.

Trans-MAPP Control participants will only need to complete one study visit to collect
baseline data and biospecimens. Potential participants will be scheduled for an eligibility
screening session. Following screening, potentially eligible participants will complete a
baseline phenotyping session, and biospecimen collections, which together are expected to
take approximately 2.5 hours to complete. Participants will be provided with breaks as
needed during the clinic visit.

The eligibility criteria for both healthy controls and positive controls are based on the
same set of criteria for the Urologic Chronic Pelvic Pain Syndrome (UCPPS) participants in
the Trans-MAPP EP Study, with exception of additional criteria to exclude chronic pelvic
pain symptoms and criteria to identify the co-morbid syndromes for the positive controls.
All entry criteria are shown below; those specific to either healthy or positive control
participants are so indicated.

Inclusion Criteria:

Participants are eligible for the Trans-MAPP Control Protocol if they meet the following
general and gender-specific criteria listed below:

1. Participant has signed and dated the appropriate Informed Consent document.

2. Agreed to participate in Trans-MAPP Control Study procedures;

Inclusion Criteria for Healthy Controls only

1. Participant reports a response of "0" (zero) on the pain, pressure or discomfort

2. Participant reports no chronic pain in the pelvic or bladder region, and reports
chronic pain in no more than one other body region.

3. Participant reports no urological symptoms that have been evaluated, but are still

Inclusion Criteria for Positive Controls only:

1. Participant meets the validated criteria for one or more of the following conditions

1. Fibromyalgia (FM)

2. Irritable bowel syndrome (IBS)

3. Chronic fatigue syndrome (CFS)

Exclusion Criteria:

Individuals will not be eligible for enrollment in the Trans-MAPP Control Study if they
meet any of the criteria:

1. Participant has an on-going symptomatic urethral stricture.

2. Participant has an on-going neurological disease or disorder affecting the bladder or
bowel fistula.

3. Participant has a history of cystitis caused by tuberculosis or radiation therapy or
Cytoxan/cyclophosphamide therapy.

4. Participant has augmentation cystoplasty or cystectomy.

5. Participant has a systemic autoimmune disorder (such as Crohn's Disease, Ulcerative
Colitis, Lupus, Rheumatoid Arthritis, or Multiple Sclerosis).

6. Participant has a history of cancer (with the exception of skin cancer).

7. 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).

8. Participant has severe cardiac, pulmonary, renal, or hepatic disease that in the
judgment of the study physician would preclude participation in this study.

Exclusion Criteria for Males Only

1. Male participant diagnosed with unilateral orchialgia, without pelvic symptoms.

2. Male participant has a history of transurethral microwave thermotherapy (TUMT),
transurethral needle ablation (TUNA), balloon dilation, or prostate cryosurgery or
laser procedure.

Exclusion Criteria for Females Only:

1) Female participant has a history of High-Grade Squamous Intraepithelial Lesion (HGSIL)
/ high-grade cervical dysplasia.
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1720 2nd Ave S
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201 East Huron Street
Chicago, Illinois 60611
(847) 491-3741
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Chicago, IL
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
Iowa City, IA
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Los Angeles, California 90095
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
Los Angeles, CA
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
Ann Arbor, MI
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St Louis, Missouri 63110
St Louis, MO
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
Stanford, CA
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