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.
Descripción general del estudio
Estado
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35205
- University of Alabama at Birmingham
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California
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Los Angeles, California, Estados Unidos, 90073
- University of California, Los Angeles
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Stanford, California, Estados Unidos, 94304
- Stanford University
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern University
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242
- University of Iowa
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48106
- University of Michigan
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Missouri
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St Louis, Missouri, Estados Unidos, 63110
- Washington University
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Washington
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Seattle, Washington, Estados Unidos, 98101
- University of Washington
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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 |
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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 |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Baseline outcome measures
Periodo de tiempo: Baseline
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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.
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Baseline
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: J. Quentin Clemens, MD, University of Michigan
- Director de estudio: Christopher Mullens, PhD, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Procesos Patológicos
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades virales
- Infecciones
- Enfermedad
- Enfermedades Gastrointestinales
- Enfermedades musculoesqueléticas
- Enfermedades reumáticas
- Enfermedades Musculares
- Enfermedades Neuromusculares
- Enfermedades del Colon Funcionales
- Enfermedades del Colon
- Enfermedades intestinales
- Encefalomielitis
- Síndrome
- Fatiga
- Síndrome del intestino irritable
- Fibromialgia
- Síndromes de dolor miofascial
- Síndrome de Fatiga Crónica
Otros números de identificación del estudio
- 810668
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