Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00248664
Status:
COMPLETED
Last Update Posted:
2010-03-03
First Post:
2005-11-03
Brief Title:
Events Preceding Interstitial Cystitis EPIC
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
A Case Control Study of Interstitial Cystitis
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPIC
Brief Summary:
EPIC is a casecontrol 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 eg 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 eg irritable bowel syndrome than do controls matched for age and gender
Specific Aim 3 To test the hypothesis that urine APF HB EGF andor 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 eg bacterial cystitis at disease onset are prognostic factors for remissions
Specific Aim 1 To test the hypothesis that certain features that precede onset of IC symptoms eg 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 eg irritable bowel syndrome than do controls matched for age and gender
Specific Aim 3 To test the hypothesis that urine APF HB EGF andor 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 eg bacterial cystitis at disease onset are prognostic factors for remissions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None