Events Preceding Interstitial Cystitis (EPIC)

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00248664
First received: November 3, 2005
Last updated: March 2, 2010
Last verified: March 2010

November 3, 2005
March 2, 2010
March 2004
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Complete list of historical versions of study NCT00248664 on ClinicalTrials.gov Archive Site
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Events Preceding Interstitial Cystitis (EPIC)
A Case Control Study of Interstitial Cystitis

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.

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.

Observational
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Cystitis, Interstitial
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
November 2008
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Inclusion Criteria: Female Adults(18 and over) who have had symotoms of IC for 12 months or fewer

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Exclusion Criteria: Males,children, those who do not have symptoms of IC or those who have had symtoms for greater than 12 months.

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Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00248664
DK64880 (completed)
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Principal Investigator: John W Warren, MD University of Maryland
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP