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NCT00248664 Clinical Trial

Events Preceding Interstitial Cystitis (EPIC)

Cystitis, Interstitial Clinical Trial

— EPIC  

Official title:
A Case Control Study of Interstitial Cystitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00248664
Other study ID # DK64880 (completed)
Secondary ID
Status Completed
Phase N/A
First received November 3, 2005
Last updated March 2, 2010
Start date March 2004
Est. completion date November 2008

Study information
Verified date March 2010
Source National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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 ΓΏ12 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.

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date November 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

N/A

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Maryland School of Medicine Baltimore Maryland

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

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