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

This study is currently recruiting participants.
Verified May 2013 by University of Pennsylvania
Sponsor:
Collaborators:
University of Colorado, Denver
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01098292
First received: April 1, 2010
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

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
Fibromyalgia
Irritable Bowel Syndrome
Fatigue Syndrome, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multidisciplinary Approach to the Study of Chronic Pelvic Pain: Trans-MAPP Control Study

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Baseline outcome measures [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 630
Study Start Date: December 2009
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01098292

Contacts
Contact: Nancy Robinson, PhD narobins@mail.med.upenn.edu
Contact: Theressa Creighton, BA theressa@mail.med.upenn.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35205
Contact: Timothy J Ness       TJNess@uab.edu   
Principal Investigator: Timothy J Ness, MD, PhD         
United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90073
Contact: Suzanne Smith, NP    310-206-0310    srsmith@mednet.ucla.edu   
Principal Investigator: Emeran A Mayer, MD         
Principal Investigator: Larissa Rodriguez, MD         
Stanford University Recruiting
Stanford, California, United States, 94304
Contact: Rachel Moericke    650-723-8250    snapl@stanford.edu   
Principal Investigator: Sean Mackey, MD, PhD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Darlene Marko, RN, BSN, CCRC    312-695-3898    d-marko@northwestern.edu   
Principal Investigator: Anthony J Schaeffer, MD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Mary Eno, RN    319-384-9265      
Principal Investigator: Karl J Kreder, MD, MBA         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Megan Halvorson    734-998-6839    meganeb@med.umich.edu   
Contact: Kathy Scott, RN    734-998-7105    jrsj@umich.edu   
Principal Investigator: Daniel J Clauw, MD         
United States, Missouri
Washington University Recruiting
St Louis, Missouri, United States, 63110
Contact: Viven Gardner, RN, BSN    314-996-8285    gardnerv@wudosis.wustl.edu   
Principal Investigator: Gerald Adriole, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98101
Contact: Annemarie Succop    206-543-9731    succop@u.washington.edu   
Contact: Susan Ross, RN, MN    206-543-3898    soross@u.washington.edu   
Principal Investigator: Dedra Buchwald, MD         
Sponsors and Collaborators
University of Pennsylvania
University of Colorado, Denver
Investigators
Study Chair: J. Quentin Clemens, MD University of Michigan
Study Director: Christopher Mullens, PhD National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

Additional Information:
No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01098292     History of Changes
Other Study ID Numbers: 810668
Study First Received: April 1, 2010
Last Updated: May 14, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Pennsylvania:
Fibromyalgia
Irritable Bowel Syndrome
Chronic Fatigue Syndrome
Interstitial Cystitis
Chronic Prostatitis
Urological Chronic Pelvic Pain
Painful Bladder Syndrome

Additional relevant MeSH terms:
Fatigue
Fatigue Syndrome, Chronic
Myofascial Pain Syndromes
Irritable Bowel Syndrome
Fibromyalgia
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014