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Events Preceding Interstitial Cystitis (EPIC) (EPIC)

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ClinicalTrials.gov Identifier: NCT00248664
Recruitment Status : Completed
First Posted : November 4, 2005
Last Update Posted : March 3, 2010
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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.

Condition or disease
Cystitis, Interstitial

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.

Study Design

Study Type : Observational
Estimated Enrollment : 400 participants
Official Title: A Case Control Study of Interstitial Cystitis
Study Start Date : March 2004
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00248664

United States, Maryland
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: John W Warren, MD University of Maryland
More Information

ClinicalTrials.gov Identifier: NCT00248664     History of Changes
Other Study ID Numbers: DK64880 (completed)
First Posted: November 4, 2005    Key Record Dates
Last Update Posted: March 3, 2010
Last Verified: March 2010

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Cystitis, Interstitial
Case-Control Studies
Risk Factors

Additional relevant MeSH terms:
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases