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

8. december 2014 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

615

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Baseline outcome measures
Tidsramme: 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
Baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Pennsylvania

Samarbejdspartnere

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

Efterforskere

  • Studiestol: J. Quentin Clemens, MD, University of Michigan
  • Studieleder: Christopher Mullens, PhD, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2009

Primær færdiggørelse (Faktiske)

1. juni 2013

Studieafslutning (Faktiske)

1. juni 2014

Datoer for studieregistrering

Først indsendt

1. april 2010

Først indsendt, der opfyldte QC-kriterier

1. april 2010

Først opslået (Skøn)

2. april 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. december 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. december 2014

Sidst verificeret

1. maj 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 810668

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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