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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.
Urologic Diseases
Observational
5
Interstitial Cystitis
Longitudinal Changes, Urinary Bladder Disease, Urogenital Disease, Urinary Symptoms, Bladder Biopsy, Interstitial Cystitis, Pathology
Division of Kidney, Urologic, and Hematologic Diseases
Document Name | Description | Document Type | File Format |
|---|---|---|---|
Dataset Name | Description | # of Records | # of Variables | File Format(s) |
|---|---|---|---|---|
FHX Form Dataset | Contains data from the FHX Form - Family History | 638 | sas7bdat (104 KB); csv (33.81 KB) | |
CONTACT Form Dataset | Contains data from the CONTACT Form - Future Contact Information | 638 | sas7bdat (64 KB); csv (37.01 KB) | |
SYMPTS Form (Pain Location Codes) Dataset | Contains data on pain locations codes from the SYMPTS form | 168 | sas7bdat (24 KB); csv (3.28 KB) | |
SURVEY Form Dataset | Contains data from the SURVEY Form - Opinion Survey | 447 | sas7bdat (200 KB); csv (54.39 KB) | |
CYST Form (Biopsy Locations) Dataset | Contains data on biopsy locations from bladder map on page 4 of CYST form | 291 | sas7bdat (24 KB); csv (7.93 KB) | |
REIN Form Dataset | Contains data from the REIN Form - Patient Reinstatement | 6 | sas7bdat (16 KB); csv (255 B) | |
VOID Form (Page 1-3) Dataset | Contains data from the VOID Form - Volume Voiding Profile | 14991 | sas7bdat (960 KB); csv (629.77 KB) | |
BIOP Form Dataset | Contains data from the BIOP Form - Biopsy | 2250 | sas7bdat (968 KB); csv (325.68 KB) | |
SYMPTS Form Dataset | Contains data from the SYMPTS Form - Symptom Questionnaire | 2653 | sas7bdat (2.45 MB); csv (784.99 KB) | |
EXCL2 Form Dataset | Contains data from the EXCL2 Form - Exclusion Checklist #2 | 638 | sas7bdat (88 KB); csv (27.5 KB) | |
BACK Form Dataset | Contains data from the BACK Form - Background Information | 638 | sas7bdat (104 KB); csv (32.42 KB) | |
Biopsy Merged Analysis Dataset | Merged analysis dataset for the biopsy data. Contains the records from the BIOP, BIOP_REV, CYST, DCYST, plus variables in the baseline.sas7bdat dataset | 2385 | sas7bdat (4.45 MB); csv (1.55 MB) | |
SYMHX Form Dataset | Contains data from the SYMHX Form - Symptom History | 638 | sas7bdat (176 KB); csv (56.77 KB) | |
QUL Form Dataset | Contains data from the QUL Form - Quality of Life | 2650 | sas7bdat (1.04 MB); csv (427.46 KB) | |
REIN Form (Codes) Dataset | Contains data on codes for the REIN patient reinstatement form | 9 | sas7bdat (16 KB); csv (339 B) | |
CYST Form Dataset | Contains data from the CYST Form - Cystoscopy | 388 | sas7bdat (88 KB); csv (25.77 KB) | |
URN Form Dataset | Contains data from the URN Form - Macroscopic Urinalysis | 2557 | sas7bdat (256 KB); csv (118.28 KB) | |
PURG Form Dataset | Contains data from the PURG Form - Pain & Urgency Scales | 5337 | sas7bdat (264 KB); csv (157.6 KB) | |
STAT Form Dataset | Contains data from the STAT Form - Patient Status | 638 | sas7bdat (40 KB); csv (28.1 KB) | |
BACK Form (Religion Codes) Dataset | Contains data on religion codes from the BACK form | 31 | sas7bdat (16 KB); csv (620 B) | |
BACK Form (Employment Stats Codes) Dataset | Contains data on employment status codes from the BACK form | 14 | csv (379 B); sas7bdat (16 KB) | |
DIET Form Dataset | Contains data from the DIET Form - Dietary Habits | 2650 | csv (250.51 KB); sas7bdat (840 KB) | |
PRIOR Form (Question 1-46) Dataset | Contains data from the PRIOR Form - Prior Diagnoses & Treatment (Questions 1-46) | 637 | sas7bdat (520 KB); csv (147.43 KB) | |
MEDHX Form Dataset | Contains data from the MEDHX Form - Patient Medical History | 638 | sas7bdat (584 KB); csv (175.72 KB) | |
SYMPH Form Dataset | Contains data from the SYMPH Form - Symptom Questionnaire | 2685 | sas7bdat (504 KB); csv (168.78 KB) | |
WITH Form Dataset | Contains data from the WITH Form - Patient Withdrawal | 185 | sas7bdat (16 KB); csv (4.28 KB) | |
WITH Form (Codes) Dataset | Contains data on codes for the WITH form | 25 | sas7bdat (16 KB); csv (749 B) | |
VOID Form (Page 4) Dataset | Contains data from the VOID Form - Volume Voiding Profile (page 4 only) | 192309 | sas7bdat (16.34 MB); csv (7.65 MB) | |
SLTR Form Dataset | Contains data from the SLTR Form - Biopsy Slide Tracking | 255 | sas7bdat (32 KB); csv (10.93 KB) | |
BACK Form (State Codes) Dataset | Contains data on state codes form the BACK form | 51 | sas7bdat (16 KB); csv (798 B) | |
EXCL3 Form Dataset | Contains data from the EXCL3 Form - Exclusion Checklist #3 | 200 | sas7bdat (16 KB); csv (4.53 KB) | |
PHS Form Dataset | Contains data from the PHS Form - Physical Exam | 868 | sas7bdat (360 KB); csv (107.18 KB) | |
Longitudinal Analysis Dataset | Contains the analytic dataset for longitudinal analyses. This data set contains one record per patient per visit date seen. Hence, if a patient’s voiding log was 5 days prior to their visit date, the voiding log record and visit information is stored on separate records | 10656 | sas7bdat (31.82 MB); csv (12.68 MB) | |
INCL Form Dataset | Contains data from the INCL Form - Inclusion Checklist | 638 | sas7bdat (88 KB); csv (29.26 KB) | |
BACK Form (Race Codes) Dataset | Contains data on race codes from the BACK form | 12 | sas7bdat (16 KB); csv (194 B) | |
UROD Form Dataset | Contains data from the UROD Form - Urodynamic Evaluation | 638 | sas7bdat (152 KB); csv (62.87 KB) | |
MEDHXF Form Dataset | Contains data from the MEDHXF Form - Patient Medical History Update | 347 | sas7bdat (208 KB); csv (48.22 KB) | |
EXCL1 Form Dataset | Contains data from the EXCL1 Form - Exclusion Checklist #1 | 638 | csv (29.42 KB); sas7bdat (88 KB) | |
MED Form Dataset | Contains data from the MED Form - Medical Events & Patient Treatment Evaluation | 4701 | sas7bdat (1.04 MB); csv (418.69 KB) | |
PREG Form Dataset | Contains data from the PREG Form - Pregnancy History | 899 | sas7bdat (152 KB); csv (53.43 KB) | |
Baseline Dataset | Baseline demographic information. Contains selected variables from the baseline i.e. V_TYPE=0 records from the following CRF forms: SUBJSTAT, BACK, PURG, SYMPTS, SYMHX, INCL, CYST, UROD, VOID, WITHD, REIN, SURVEY, PRIOR, MEDHX, FHX | 637 | sas7bdat (1.2 MB); csv (399.31 KB) | |
PRIOR Form (Question 47+) Dataset | Contains data from the PRIOR Form - Prior Diagnoses & Treatment (Questions 47+) | 142 | sas7bdat (24 KB); csv (4.38 KB) | |
PHYTRT Form Dataset | Contains data from the PHYTRT Form - Physician's Evaluation & Treatment Plan | 5297 | sas7bdat (472 KB); csv (237.44 KB) | |
TRACK Form Dataset | Contains data from the TRACK Form - Biopsy Specimen Tracking | 255 | sas7bdat (32 KB); csv (11.52 KB) | |
SCR Form Dataset | Contains data from the SCR Form - Screening | 638 | sas7bdat (40 KB); csv (16.87 KB) | |
BIOP Form (Specimen Data) Dataset | Contains data on batch number, specimen, and slide adequacy for each specimen included in the biopsy review | 764 | sas7bdat (88 KB); csv (31.88 KB) | |
CYST Form (Pathology Location Codes) Dataset | Contains data on pathology location codes and pathology type codes for the CYST form | 367 | sas7bdat (32 KB); csv (9.92 KB) | |
CMED Form Dataset | Contains data from the CMED Form - Concomitant Medications | 8386 | sas7bdat (680 KB); csv (357.66 KB) | |
Summary Voiding Log Dataset | Summary of the voiding log data for each of the 3 days with derived variables for total number of nocturnal voids, total number of 24 hour voids, total volume, average volume, minimum volume, maximum volume | 15328 | sas7bdat (5.95 MB); csv (2.28 MB) | |
DEF1 Form Dataset | Contains data from the DEF1 Form - Deferral Checklist #1 | 638 | sas7bdat (88 KB); csv (27.46 KB) | |
BACKF Form Dataset | Contains data from the BACKF Form - Background Information | 346 | sas7bdat (40 KB); csv (13.22 KB) | |
BACK Form (Country Codes) Dataset | Contains data on Country codes from the BACK form | 25 | sas7bdat (16 KB); csv (364 B) | |
BMAP Dataset | Captures data on codes for biopsy location from CYST, SLTR, and TRACK forms | 23 | sas7bdat (16 KB); csv (677 B) | |
HEM Form Dataset | Contains data from the HEM Form - Hematology | 635 | sas7bdat (88 KB); csv (40.76 KB) | |
DEF2 Form Dataset | Contains data from the DEF2 Form - Deferral Checklist #2 | 638 | sas7bdat (72 KB); csv (25.65 KB) | |
CMED Form (Medications/Treatments Codes) Dataset | Contains data on codes for medications and treatments for the CMED form | 2232 | sas7bdat (208 KB); csv (60.23 KB) |
Specimen | Count |
|---|---|
| Bladder Tissue | 25919 |