MAPP-Control: Observational Study of Control Participants for the MAPP Research Network

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT01098292

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH), University of Colorado, Denver (Other)

615

Enrollment

Locations

Duration (Months)

76.9

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

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 :

Dec 1, 2009

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Baseline outcome measures [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. General Measures of Sociodemographics, Health, and Quality of Life UCPPS Symptoms Measures Non-urological Symptom Measures Trait-like Personal Factors Biological Specimens

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

Participant has signed and dated the appropriate Informed Consent document.
Agreed to participate in Trans-MAPP Control Study procedures;

Inclusion Criteria for Healthy Controls only

Participant reports a response of "0" (zero) on the pain, pressure or discomfort scale.
Participant reports no chronic pain in the pelvic or bladder region, and reports chronic pain in no more than one other body region.
Participant reports no urological symptoms that have been evaluated, but are still present.

Inclusion Criteria for Positive Controls only:

Participant meets the validated criteria for one or more of the following conditions
Fibromyalgia (FM)
Irritable bowel syndrome (IBS)
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:

Participant has an on-going symptomatic urethral stricture.
Participant has an on-going neurological disease or disorder affecting the bladder or bowel fistula.
Participant has a history of cystitis caused by tuberculosis or radiation therapy or Cytoxan/cyclophosphamide therapy.
Participant has augmentation cystoplasty or cystectomy.
Participant has a systemic autoimmune disorder (such as Crohn's Disease, Ulcerative Colitis, Lupus, Rheumatoid Arthritis, or Multiple Sclerosis).
Participant has a history of cancer (with the exception of skin cancer).
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).
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

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

Female participant has a history of High-Grade Squamous Intraepithelial Lesion (HGSIL) / high-grade cervical dysplasia.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35205
2	University of California, Los Angeles	Los Angeles	California	United States	90073
3	Stanford University	Stanford	California	United States	94304
4	Northwestern University	Chicago	Illinois	United States	60611
5	University of Iowa	Iowa City	Iowa	United States	52242
6	University of Michigan	Ann Arbor	Michigan	United States	48106
7	Washington University	St Louis	Missouri	United States	63110
8	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

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)