- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
상세 설명
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35205
- University of Alabama at Birmingham
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California
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Los Angeles, California, 미국, 90073
- University of California, Los Angeles
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Stanford, California, 미국, 94304
- Stanford University
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Illinois
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Chicago, Illinois, 미국, 60611
- Northwestern University
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Iowa
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Iowa City, Iowa, 미국, 52242
- University of Iowa
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Michigan
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Ann Arbor, Michigan, 미국, 48106
- University of Michigan
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Missouri
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St Louis, Missouri, 미국, 63110
- Washington University
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Washington
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Seattle, Washington, 미국, 98101
- University of Washington
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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 |
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 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Baseline outcome measures
기간: 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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공동 작업자 및 조사자
협력자
수사관
- 연구 의자: J. Quentin Clemens, MD, University of Michigan
- 연구 책임자: Christopher Mullens, PhD, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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