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Observational Study of Control Participants for the MAPP Research Network (MAPP-Control)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01098292
Recruitment Status : Completed
First Posted : April 2, 2010
Last Update Posted : December 10, 2014
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Colorado, Denver
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:

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.

Condition or disease
Fibromyalgia Irritable Bowel Syndrome Fatigue Syndrome, Chronic

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 615 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multidisciplinary Approach to the Study of Chronic Pelvic Pain: Trans-MAPP Control Study
Study Start Date : December 2009
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

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

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

Primary Outcome Measures :
  1. Baseline outcome measures [ Time Frame: Baseline ]

    Extensive data on risk factors and outcomes measures will be collected for the Trans-MAPP Control Study. These measures can be classified into a number of primary domains as described below.

    1. General Measures of Sociodemographics, Health, and Quality of Life
    2. UCPPS Symptoms Measures
    3. Non-urological Symptom Measures
    4. Trait-like Personal Factors
    5. Biological Specimens

Biospecimen Retention:   Samples With DNA
DNA Blood Urine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The Trans-MAPP Control Study population will include adult participants, at least 18 years of age, with no urological chronic pelvic pain syndromes. These participants will fall into two categories: Healthy Controls and Positive Controls.

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 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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01098292

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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35205
United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90073
Stanford University
Stanford, California, United States, 94304
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48106
United States, Missouri
Washington University
St Louis, Missouri, United States, 63110
United States, Washington
University of Washington
Seattle, Washington, United States, 98101
Sponsors and Collaborators
University of Pennsylvania
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Colorado, Denver
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Study Chair: J. Quentin Clemens, MD University of Michigan
Study Director: Christopher Mullens, PhD National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional Information:
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Responsible Party: University of Pennsylvania Identifier: NCT01098292     History of Changes
Other Study ID Numbers: 810668
First Posted: April 2, 2010    Key Record Dates
Last Update Posted: December 10, 2014
Last Verified: May 2013
Keywords provided by University of Pennsylvania:
Irritable Bowel Syndrome
Chronic Fatigue Syndrome
Interstitial Cystitis
Chronic Prostatitis
Urological Chronic Pelvic Pain
Painful Bladder Syndrome
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Myofascial Pain Syndromes
Irritable Bowel Syndrome
Pathologic Processes
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Virus Diseases
Central Nervous System Diseases