Events Preceding Interstitial Cystitis (EPIC)

Completed

• Conditions: Cystitis, Interstitial

• Registration Number: NCT00248664
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2005-11-03
• Study First Submitted QC: 2005-11-03
• Study First Posted: 2005-11-04
• Study Completion: 2008-11
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-02
• Last Update Posted: 2010-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

University of Maryland School of Medicine; 🇺🇸 Baltimore, Maryland, United States