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

8 december 2014 bijgewerkt door: University of Pennsylvania

Multidisciplinary Approach to the Study of Chronic Pelvic Pain: Trans-MAPP Control Study

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

615

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Verenigde Staten
- Alabama
  - Birmingham, Alabama, Verenigde Staten, 35205
    - University of Alabama at Birmingham
- California
  - Los Angeles, California, Verenigde Staten, 90073
    - University of California, Los Angeles
  - Stanford, California, Verenigde Staten, 94304
    - Stanford University
- Illinois
  - Chicago, Illinois, Verenigde Staten, 60611
    - Northwestern University
- Iowa
  - Iowa City, Iowa, Verenigde Staten, 52242
    - University of Iowa
- Michigan
  - Ann Arbor, Michigan, Verenigde Staten, 48106
    - University of Michigan
- Missouri
  - St Louis, Missouri, Verenigde Staten, 63110
    - Washington University
- Washington
  - Seattle, Washington, Verenigde Staten, 98101
    - University of Washington

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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:

1. 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:

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Baseline outcome measures Tijdsspanne: 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	Baseline

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Pennsylvania

Medewerkers

University of Colorado, Denver

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Onderzoekers

Studie stoel: J. Quentin Clemens, MD, University of Michigan
Studie directeur: Christopher Mullens, PhD, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

MAPP Research Network Website

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 december 2009

Primaire voltooiing (Werkelijk)

1 juni 2013

Studie voltooiing (Werkelijk)

1 juni 2014

Studieregistratiedata

Eerst ingediend

1 april 2010

Eerst ingediend dat voldeed aan de QC-criteria