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

2014年12月8日更新者：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.

調査の概要

状態

完了

条件

詳細な説明

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.

研究の種類

観察的

入学 (実際)

615

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

グループ/コホートの数

コホートと介入

グループ/コホート
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

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
Baseline outcome measures 時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of Pennsylvania

協力者

University of Colorado, Denver

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

捜査官

スタディチェア：J. Quentin Clemens, MD、University Of Michigan
スタディディレクター：Christopher Mullens, PhD、National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

MAPP Research Network Website

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2009年12月1日

一次修了 (実際)

2013年6月1日

研究の完了 (実際)

2014年6月1日

試験登録日

最初に提出

2010年4月1日

QC基準を満たした最初の提出物