Events Preceding Interstitial Cystitis (EPIC)

NCT ID: NCT00248664

Last Updated: 2010-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-03-31

Study Completion Date

2008-11-30

Brief Summary

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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

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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.

Conditions

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Cystitis, Interstitial

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role lead

Principal Investigators

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John W Warren, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

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University of Maryland School of Medicine

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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DK64880 (completed)

Identifier Type: -

Identifier Source: org_study_id

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