CDE Detailed Report

Disease: Spinal Cord Injury
Sub-Domain: The International SCI Data Sets
CRF: International SCI Urodynamic Basic Data Set

Displaying 1 - 12 of 12
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (Question Text) Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C06262 Bladder function detrusor leak point pressure value BldrFuncDtrsrLekPntPressrVal Value of the lowest detrusor pressure on the participant/subject at which urine leakage occurs The lowest detrusor pressure on the participant/subject at which urine leakage occurs Detrusor leak point pressure Numeric Values

Document the detrusor leak point pressure in cm H2O during filling cystometry. Up to three digits without decimals should be used.

Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A. The Standardisation of Terminology of Lower Urinary Tract Function: Report from the Standardisation Sub-committee of the International Continence Society. Neurourology and Urodynamics 2002:21;167-78. Biering-SØrensen F, Craggs M, Kennelly M, Schick E, Wyndaele JJ. International urodynamic basic spinal cord injury data set. Spinal Cord 2008 Jul;46(7):513-6. Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Urodynamic Basic Data Set The International SCI Data Sets The International SCI Data Sets

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centimeter of water
C06263 Bladder function detrusor maximum pressure value BldrFuncDetrusorMaxPressrVal Value of the maximum detrusor pressure on the participant/subject during filling cystometry Value of the maximum detrusor pressure on the participant/subject during filling cystometry Maximum detrusor pressure Numeric Values

Document the maximum detrusor pressure in cm H2O during filling cystometry. Up to three digits without decimals should be used.

Biering-SØrensen F, Craggs M, Kennelly M, Schick E, Wyndaele JJ. International urodynamic basic spinal cord injury data set. Spinal Cord 2008 Jul;46(7):513-6. Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Urodynamic Basic Data Set The International SCI Data Sets The International SCI Data Sets

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centimeter of water
C06264 Bladder function bladder capacity value BldrFuncBldrCapacityVal Value of the bladder capacity of participant/subject during cystometry Value of the bladder capacity of participant/subject during cystometry Cystometric bladder capacity Numeric Values

Document the cystometric bladder capacity in mL during filling cystometry. Up to four digits without decimals should be used.

Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A. The Standardisation of Terminology of Lower Urinary Tract Function: Report from the Standardisation Sub-committee of the International Continence Society. Neurourology and Urodynamics 2002:21;167-78. Biering-SØrensen F, Craggs M, Kennelly M, Schick E, Wyndaele JJ. International urodynamic basic spinal cord injury data set. Spinal Cord 2008 Jul;46(7):513-6. Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Urodynamic Basic Data Set The International SCI Data Sets The International SCI Data Sets

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milliliter
C06265 Bladder function post void volume value BldrFuncPostVoidVolVal Value for the residual bladder volume of participant/subject after cystometry Value for the residual bladder volume of participant/subject after cystometry Post void residual volume Numeric Values

Document the post void residual volume. Up to four digits without decimals should be used.

Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A. The Standardisation of Terminology of Lower Urinary Tract Function: Report from the Standardisation Sub-committee of the International Continence Society. Neurourology and Urodynamics 2002:21;167-78. Biering-SØrensen F, Craggs M, Kennelly M, Schick E, Wyndaele JJ. International urodynamic basic spinal cord injury data set. Spinal Cord 2008 Jul;46(7):513-6. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Urodynamic Basic Data Set The International SCI Data Sets The International SCI Data Sets

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milliliter
C19247 Subject ID SubIDNam Subject identification ID Subject identification ID Subject Alphanumeric

The participant or subject identifiers or IDs should be assigned by the study.

Biering-SØrensen F, Craggs M, Kennelly M, Schick E, Wyndaele JJ. International urodynamic basic spinal cord injury data set. Spinal Cord 2008 Jul;46(7):513-6. Adult;Pediatric Supplemental 1.00 2014-06-05 13:10:49.0 International SCI Urodynamic Basic Data Set The International SCI Data Sets The International SCI Data Sets 255

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C06000 Site identifier number SiteIDNum Unique identification number given to the study site to distinguish the location where data is recorded. Unique identification number given to the study site to distinguish the location where data is recorded. Site Alphanumeric

The site identifiers or IDs should be assigned by the study.

Biering-SØrensen F, Craggs M, Kennelly M, Schick E, Wyndaele JJ. International urodynamic basic spinal cord injury data set. Spinal Cord 2008 Jul;46(7):513-6. Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Urodynamic Basic Data Set The International SCI Data Sets The International SCI Data Sets 255

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C19342 Measurement not reported reason MeasrmntNotReptdRsn The reason that a value was not reported for a measurement. The reason that a value was not reported for a measurement. Not applicable;Unknown Not applicable;Unknown Alphanumeric Adult Supplemental 1.00 2014-06-11 13:48:56.0 International SCI Urodynamic Basic Data Set The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

C06005 Data collected date and time DataCollDateTime Date (and time, if applicable and known) the data were collected. This may be the date/time a particular examination or procedure was performed. Date (and time, if applicable and known) the data were collected. This may be the date/time a particular examination or procedure was performed. Date performed Date or Date & Time

Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).

Biering-SØrensen F, Craggs M, Kennelly M, Schick E, Wyndaele JJ. International urodynamic basic spinal cord injury data set. Spinal Cord 2008 Jul;46(7):513-6. Adult;Pediatric Supplemental 3.00 2013-07-24 21:00:23.88 International SCI Urodynamic Basic Data Set The International SCI Data Sets The International SCI Data Sets

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C06258 Bladder function bladder sensation type BldrFuncBldrSensationTyp Documents the bladder sensation during filling cystometry. Although the bladder sensation is assessed during filling cystometry the assumption that it is sensation from the bladder alone, without urethral or pelvic components may be false (Abrams et al. 2002). Normal bladder sensation can be judged by three defined points noted during filling cystometry and evaluated in relation to the bladder volume at that moment and in relation to the patient's symptomatic complaints. Type of bladder sensation of the participant/subject during filling cystometry Bladder sensation during filling cystometry Normal;Increased;Reduced;Absent;Non-specific;Unknown Can be judged by three defined points noted (see CDE instructions) during filling cystometry and evaluated in relation to the bladder volume at that moment and in relation to the patient's symptomatic complaints.;Bladder sensation is defined, during filling cystometry, as an early first sensation of bladder filling (or an early desire to void) and/or an early strong desire to void, which occurs at low bladder volume and which persists.;Is defined, during filling cystometry, as diminished sensation throughout bladder filling.;Bladder sensation means that, during filling cystometry, the individual has no bladder sensation.;Bladder sensation, during filling cystometry, may make the individual aware of bladder filling, for example, abdominal fullness or vegetative symptoms.;Is used if the observation regarding bladder sensation during filing cystometry is not available. Alphanumeric

Choose one. The three defined points noted during filling cystometry are as follows: 1. First sensation of bladder filling is the feeling the patient has, during filling cystometry, when he/she first becomes aware of the bladder filling. 2. First desire to void is defined as the feeling, during filling cystometry, that would lead the patient to pass urine at the next convenient moment, but voiding can be delayed if necessary. 3. Strong desire to void this is defined, during filling cystometry, as a persistent desire to void without the fear of leakage.

Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A. The Standardisation of Terminology of Lower Urinary Tract Function: Report from the Standardisation Sub-committee of the International Continence Society. Neurourology and Urodynamics 2002:21;167-78. Biering-SØrensen F, Craggs M, Kennelly M, Schick E, Wyndaele JJ. International urodynamic basic spinal cord injury data set. Spinal Cord 2008 Jul;46(7):513-6. Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Urodynamic Basic Data Set The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

C06259 Bladder function detrusor function type BldrFuncDetrusorFunctionTyp Type of magnitude of the detrusor function on the participant/subject Type of magnitude of the detrusor function on the participant/subject Detrusor function Normal;Neurogenic detrusor overactivity;Underactive detrusor;Acontractile detrusor;Unknown Detrusor function allows bladder filling with little or no change in pressure. No involuntary phasic contractions occur despite provocation. Normal voiding is achieved by a voluntary initiated continuous detrusor contraction that leads to complete bladder emptying within a normal time span, and in the absence of obstruction. For a given detrusor contraction, the magnitude of the recorded pressure rise will depend on the degree of outlet resistance (Abrams et al. 2002).;Is a urodynamic observation in individuals with a neurological condition characterized by involuntary detrusor contractions during the filling phase which may be spontaneous or provoked (Abrams et al. 2002).;Is defined as a contraction of reduced strength and/or duration, resulting in prolonged bladder emptying and/or a failure to achieve complete bladder emptying within a normal time span (Abrams et al. 2002).;Is one that cannot be demonstrated to contract during urodynamic studies (Abrams et al. 2002).;Is used if the observation regarding detrusor function is not available. Alphanumeric

Choose one

Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A. The Standardisation of Terminology of Lower Urinary Tract Function: Report from the Standardisation Sub-committee of the International Continence Society. Neurourology and Urodynamics 2002:21;167-78. Biering-SØrensen F, Craggs M, Kennelly M, Schick E, Wyndaele JJ. International urodynamic basic spinal cord injury data set. Spinal Cord 2008 Jul;46(7):513-6. Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Urodynamic Basic Data Set The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

C06260 Bladder function bladder compliance type BldrFuncBladderComplianceTyp Type of bladder compliance of the participant/subject during filling cystometry Type of bladder compliance of the participant/subject during filling cystometry Compliance during filing cystometry Yes;No;Unknown Yes;No;Unknown Alphanumeric

The International Continence Society recommends to calculate the bladder compliance using two standard points: 1) the detrusor pressure at the start on the bladder filling and the corresponding bladder volume (usually zero), and 2) the detrusor pressure (and corresponding bladder volume) at cystometric capacity or immediately before the start of any detrusor contraction that causes significant leakage (and therefore causes the bladder volume to decrease, affecting compliance calculation). Both points are measured excluding any detrusor contraction (Abrams et al. 2002). Unknown is used if the observation regarding bladder compliance during filling cystometry is not available.

Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A. The Standardisation of Terminology of Lower Urinary Tract Function: Report from the Standardisation Sub-committee of the International Continence Society. Neurourology and Urodynamics 2002:21;167-78. Biering-SØrensen F, Craggs M, Kennelly M, Schick E, Wyndaele JJ. International urodynamic basic spinal cord injury data set. Spinal Cord 2008 Jul;46(7):513-6. Weld KJ, Graney MJ, Dmochowski RR. Differences in bladder compliance with time and associations of bladder management with compliance in spinal cord injured patients. J Urol 2000;163:1228-33. Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Urodynamic Basic Data Set The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

C06261 Bladder function urethral function type BldrFuncUrethralFuncTyp Type of urethral function of the participant/subject during voiding Type of urethral function of the participant/subject during voiding Urethral function during voiding Normal;Detrusor sphincter dyssynergia;Non-relaxing urethral sphincter obstruction;Not applicable;Unknown Is defined as a urethra that opens and is continuous relaxed to allow the bladder to be emptied at a normal pressure (Abrams et al. 2002).;Is defined as detrusor contraction concurrent with an involuntary contraction of the urethral and/or periurethral striated muscle. Occasionally flow may be prevented altogether (Abrams et al. 2002).;Is characterised by a non-relaxing, obstructing urethra resulting in reduced urine flow (Abrams et al. 2002).;Should be used if the individual with a spinal cord lesion for example has acontractile detrusor.;Is used if the observation regarding function during voiding is not available. Alphanumeric

Choose one

Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A. The Standardisation of Terminology of Lower Urinary Tract Function: Report from the Standardisation Sub-committee of the International Continence Society. Neurourology and Urodynamics 2002:21;167-78. Biering-SØrensen F, Craggs M, Kennelly M, Schick E, Wyndaele JJ. International urodynamic basic spinal cord injury data set. Spinal Cord 2008 Jul;46(7):513-6. Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Urodynamic Basic Data Set The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

CSV