- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01098292
Observational Study of Control Participants for the MAPP Research Network (MAPP-Control)
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.
Visão geral do estudo
Status
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
Alabama
-
Birmingham, Alabama, Estados Unidos, 35205
- University of Alabama at Birmingham
-
-
California
-
Los Angeles, California, Estados Unidos, 90073
- University of California, Los Angeles
-
Stanford, California, Estados Unidos, 94304
- Stanford University
-
-
Illinois
-
Chicago, Illinois, Estados Unidos, 60611
- Northwestern University
-
-
Iowa
-
Iowa City, Iowa, Estados Unidos, 52242
- University of Iowa
-
-
Michigan
-
Ann Arbor, Michigan, Estados Unidos, 48106
- University of Michigan
-
-
Missouri
-
St Louis, Missouri, Estados Unidos, 63110
- Washington University
-
-
Washington
-
Seattle, Washington, Estados Unidos, 98101
- University of Washington
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
---|
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 |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Baseline outcome measures
Prazo: 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.
|
Baseline
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: J. Quentin Clemens, MD, University of Michigan
- Diretor de estudo: Christopher Mullens, PhD, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças do aparelho digestivo
- Processos Patológicos
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Doenças Virais
- Infecções
- Doença
- Doenças Gastrointestinais
- Doenças musculoesqueléticas
- Doenças Reumáticas
- Doenças Musculares
- Doenças Neuromusculares
- Doenças Colônicas Funcionais
- Doenças do cólon
- Doenças Intestinais
- Encefalomielite
- Síndrome
- Fadiga
- Síndrome do intestino irritável
- Fibromialgia
- Síndromes Dolorosas Miofasciais
- Síndrome de Fadiga, Crônica
Outros números de identificação do estudo
- 810668
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .