Events Preceding Interstitial Cystitis (EPIC) (EPIC)
Primary Purpose
Cystitis, Interstitial
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cystitis, Interstitial focused on measuring Cystitis, Interstitial, Case-Control Studies, Risk Factors
Eligibility Criteria
Inclusion Criteria: Female Adults(18 and over) who have had symotoms of IC for 12 months or fewer - Exclusion Criteria: Males,children, those who do not have symptoms of IC or those who have had symtoms for greater than 12 months. -
Sites / Locations
- University of Maryland School of Medicine
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00248664
First Posted
November 3, 2005
Last Updated
March 2, 2010
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00248664
Brief Title
Events Preceding Interstitial Cystitis (EPIC)
Acronym
EPIC
Official Title
A Case Control Study of Interstitial Cystitis
Study Type
Observational
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
5. Study Description
Brief Summary
EPIC is a case/control study that seeks to identify the risk factors for interstitial cystitis by comparing the experiences and medical histories of 400 women who recently developed IC with 400 similar people who do not have the disease.
Detailed Description
This project is a systematic, national study of incident IC cases and controls matched by age and gender. By telephone interview and medical record review, we compare exposures of cases and controls seeking significant differences which may be risk factors for IC. This cohort of incident IC cases will initiate a natural history study of the disease.
Specific Aim 1. To test the hypothesis that certain features that precede onset of IC symptoms, e.g., bacterial cystitis, distinguish IC cases from controls matched for age and gender, and may be risk factors for the disease.
Specific Aim 2. To test the hypotheses that patients with IC have higher prevalences of certain non bladder syndromes, e.g., irritable bowel syndrome, than do controls matched for age and gender.
Specific Aim 3. To test the hypothesis that urine APF, HB EGF, and/or EGF are sensitive and specific diagnostic markers for IC in patients with symptoms of ÿ12 months.
Specific Aim 4. To test the hypotheses that, in an incident cohort, patients with IC have remissions and that certain clinical features, e.g., bacterial cystitis at disease onset, are prognostic factors for remissions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystitis, Interstitial
Keywords
Cystitis, Interstitial, Case-Control Studies, Risk Factors
7. Study Design
Enrollment
400 (Anticipated)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female Adults(18 and over) who have had symotoms of IC for 12 months or fewer
-
Exclusion Criteria: Males,children, those who do not have symptoms of IC or those who have had symtoms for greater than 12 months.
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John W Warren, MD
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
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Events Preceding Interstitial Cystitis (EPIC)
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