Clinical trial NCT01098292: Observational Study of Control Participants for the MAPP Research Network
Official title: Multidisciplinary Approach to the Study of Chronic Pelvic Pain: Trans-MAPP Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Irritable Bowel Syndrome
Fatigue Syndrome, Chronic
Keywords: Fibromyalgia
Irritable Bowel Syndrome
Chronic Fatigue Syndrome
Interstitial Cystitis
Chronic Prostatitis
Urological Chronic Pelvic Pain
Painful Bladder Syndrome
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: University of Colorado, Denver
First posted: 2010-04-02
Enrollment: 615
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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.

Primary outcomes:
measure: Baseline outcome measures
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: St Louis
country: United States
facility: Washington University
state: Missouri
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Michigan
name: J. Quentin Clemens, MD
role: STUDY_CHAIR
affiliation: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Christopher Mullens, PhD
role: STUDY_DIRECTOR
References: