Interstitial Cystitis cohort study (ICDB)
Number of Subjects in Study Archive: 637
Study Design: Prospective Cohort
Conditions: Cystitis, Interstitial, Urinary Bladder Diseases, Urogenital Diseases
Duration: 1993 — 1997
# Recruitment Centers: 5
Treatment: None, observational only
Available Genotype Data: No
Image Summary: Yes
Transplant Type: None
Does it have dialysis patients: No
The Interstitial Cystitis Data Base (ICDB) cohort study was a prospective, multicenter clinical study of patients with Interstitial Cystitis (IC). The study gathered data to investigate the treated history of IC and identify patient subgroups with specific symptoms, physical findings, histopathologic findings from bladder biopsies, and treatment responses. Data was collected on patients at baseline and longitudinally concerning demographic and diagnostic information, medical history, dietary intake, urinary symptoms, and treatments and their outcomes. Additionally, bladder tissue specimens were stored in a specimen bank. Initial analyses on patient data supported the clinical observation that IC is a chronic symptom complex and showed that no current treatments had a significant impact on symptoms over time.
The ICDB study had three main objectives: (1) to determine the treated history of IC based on longitudinal patient data, (2) to identify the age, sex, race, and other demographic characteristics of patients in the database with symptoms consistent with IC, and (3) to maintain a bladder biopsy specimen bank.
Longitudinal changes of urinary symptoms, the impact of interstitial cystitis on quality of life, treatment patterns, and the relationship between pathology, bladder biopsies, and patient symptoms were used as outcome measures.
Participants of at least 18 years of age who (1) had symptoms of urinary urgency, frequency, or pain for at least the past 6 months and (2) scored at least 1 on the frequency, pain, or urgency scale were enrolled in the ICDB study. Exclusion criteria are documented in the study protocol.
The study found that initial analyses on patient data supported the clinical observation that IC is a chronic disease and showed that no current treatments had a significant impact on symptoms over time.