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Citation
Landis, Richard (2016). Interstitial Cystitis cohort study (ICDB) (Version 2) [Dataset] NIDDK Central Repository. https://doi.org/10.58020/mvyb-pd38
Data Availability Statement
Data from the Interstitial Cystitis cohort study (ICDB) [(Version 2) https://doi.org/10.58020/mvyb-pd38] reported here are available for request at the NIDDK Central Repository (NIDDK-CR) website, Resources for Research (R4R), https://repository.niddk.nih.gov/.
Acknowledgement Statement
The ICDB study was conducted by the study investigators and supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The resources from the ICDB (https://doi.org/10.58020/mvyb-pd38) study reported here were supplied by NIDDK Central Repository (NIDDK-CR) and are available for request at https://repository.niddk.nih.gov. This manuscript was not prepared under the auspices of the ICDB study and does not necessarily reflect the opinions or views of the ICDB study, NIDDK-CR, or NIDDK.
Data Package Version
Version 2 (Updated on: May 16, 2016)
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General Description

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.

Primary Objectives

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.

Outcome Measure

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.

Inclusion Criteria

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.

Outcome

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.

Research Area

Urologic Diseases

Study Type

Observational

Study Sites

5

Condition

Interstitial Cystitis

Medication or Intervention Agent

None

Procedure

None

Keywords

Urinary Bladder Disease, Longitudinal Changes, Urogenital Disease, Pathology, Bladder Biopsy, Urinary Symptoms, Interstitial Cystitis

NIDDK Division

Division of Kidney, Urologic, and Hematologic Diseases (KUH)

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Certificate of Confidentiality
  • NIDDK-CR has determined that this NIDDK-funded study meets the criteria deemed to be issued a Certificate of Confidentiality. More information on what this means to Requestors is available in the NIH FAQ.

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Specimens (25,919)
Specimens Table
Specimen
Count
Bladder Tissue25919