Observational Study of Control Participants for the MAPP Research Network
NCT ID: NCT01098292
Last Updated: 2014-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
615 participants
OBSERVATIONAL
2009-12-31
2014-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Healthy Control
Healthy Control participants do not suffer from any Urological Chronic Pelvic Pain Syndromes or from the following conditions:
Fibromyalgia, Irritable Bowel Syndrome, Chronic Fatigue Syndrome
No interventions assigned to this group
Positive Control
Positive Control participants do not suffer from any Urological Pelvic Pain Syndromes like Interstitial Cystitis and/or Chronic Prostatitis. However Positive Controls have a history of one of the following conditions:
Fibromyalgia, Irritable Bowel Syndrome, Chronic Fatigue Syndrome
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
1. Participant has signed and dated the appropriate Informed Consent document.
2. Agreed to participate in Trans-MAPP Control Study procedures;
1. Participant reports a response of "0" (zero) on the pain, pressure or discomfort scale.
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 present.
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
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.
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.
1\) Female participant has a history of High-Grade Squamous Intraepithelial Lesion (HGSIL) / high-grade cervical dysplasia.
18 Years
ALL
Yes
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Colorado, Denver
OTHER
University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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J. Quentin Clemens, MD
Role: STUDY_CHAIR
University of Michigan
Christopher Mullens, PhD
Role: STUDY_DIRECTOR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California, Los Angeles
Los Angeles, California, United States
Stanford University
Stanford, California, United States
Northwestern University
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
University of Michigan
Ann Arbor, Michigan, United States
Washington University
St Louis, Missouri, United States
University of Washington
Seattle, Washington, United States
Countries
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Related Links
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MAPP Research Network Website
Other Identifiers
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810668
Identifier Type: -
Identifier Source: org_study_id