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ID

31549

Description

Efficacy of Clean Intermittent Catheterization (CIC) in Multiple Sclerosis (MS) Patients With Bladder Dysfunction; ODM derived from: https://clinicaltrials.gov/show/NCT00913510 Sponsor: Wellspect HealthCare Information provided by (Responsible Party): Wellspect HealthCare Principal Investigator: Clare Fowler, Prof. University College, London

Link

https://clinicaltrials.gov/show/NCT00913510

Keywords

Versions (1)
  1. 9/3/18 9/3/18 -
Copyright Holder

Wellspect HealthCare

Uploaded on

September 3, 2018

DOI

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Creative Commons BY-NC 3.0
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    Eligibility Bladder Dysfunction in MS NCT00913510

    English

    Eligibility Bladder Dysfunction in MS NCT00913510

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    provision of informed consent
    Description

    Informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    male and female patients aged 18 years and over
    Description

    Gender and age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2]
    C0001779
    ms patients that are already currently treated or eligible for treatment with anticholinergic drugs
    Description

    ms patients that are already currently treated or eligible for treatment with anticholinergic drugs

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0026769
    UMLS CUI [1,2]
    C2827774
    UMLS CUI [1,3]
    C0242896
    UMLS CUI [2,1]
    C0026769
    UMLS CUI [2,2]
    C1548635
    UMLS CUI [2,3]
    C0242896
    patient with previously confirmed multiple sclerosis according to mcdonald criteria and level of disability less than 6.5 on the kutzke scale and have been stable for 6 months
    Description

    Previous confirmation of ms according to mcdonald criteria and level of disability less than 6.5 on the kutzke scale, current stable status for 6 months

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0026769
    UMLS CUI [1,2]
    C0679228
    UMLS CUI [2,1]
    C0012605
    UMLS CUI [2,2]
    C0451246
    UMLS CUI [3,1]
    C0521116
    UMLS CUI [3,2]
    C0205360
    the patient has all or any bladder symptoms; urgency, frequency, incontinence, nocturia, pvr
    Description

    Presence of bladder symptoms such as urgency, frequency, incontinence, nocturia, pvr

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0232841
    UMLS CUI [2]
    C0085606
    UMLS CUI [3]
    C2584336
    UMLS CUI [4]
    C0042024
    UMLS CUI [5]
    C0028734
    UMLS CUI [6,1]
    C0429774
    UMLS CUI [6,2]
    C1439885
    the patient has frequency symptoms > 8 voiding per 24 h
    Description

    Frequency symptoms > 8 voiding per 24h

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2584336
    the patient has pvr > 50 ml, measured at two repetitive bladder scan measurements during the screening phase as well as the randomization visit
    Description

    pvr > 50 ml, measured during screening phase and the randomization visit

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3839465
    UMLS CUI [1,2]
    C4060656
    adequate mobility to lower limbs, sufficient hand function and ability to practice cic at least three times daily
    Description

    Adequate mobility to lower limbs, sufficient hand function and ability to practice cic

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0231434
    UMLS CUI [1,2]
    C0018563
    UMLS CUI [2,1]
    C0231434
    UMLS CUI [2,2]
    C1140621
    UMLS CUI [3,1]
    C0085732
    UMLS CUI [3,2]
    C2936294
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    pregnancy
    Description

    Pregnancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    ongoing symptomatic urinary tract infection (uti) as judged by investigator
    Description

    Urinary tract infection

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0042029
    involvement in the planning and conduct of the study (applies to both astra tech staff or staff at the study site)
    Description

    Involvement in planning and conduct of the study

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2603343
    UMLS CUI [1,2]
    C0851286
    the patient practices cic prior the study
    Description

    Practice of cic prior to the study

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463
    UMLS CUI [1,2]
    C2936294
    the patient has undergone a sphincterectomy
    Description

    Status post sphincterectomy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1262069
    progressive "relapsing- remitting ms" as judged by the investigator
    Description

    Progressive relapsing- remitting ms

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1335499
    UMLS CUI [1,2]
    C0751967
    severe non-compliance to protocol as judged by the investigator and/or astra tech
    Description

    Severe non-compliance to protocol

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0457432
    UMLS CUI [1,2]
    C2348563
    the patient is participating in other study that might have an impact on the outcome of this, as judged by investigator
    Description

    Concurrent participation in other study that might have an impact on the outcome of this, as judged by investigator

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C4054723
    pvr > 250 ml, measured at two repetitive bladder scan measurements during the screening phase as well as the randomization visit and or if bladder voiding efficiency (bve) at visit 2 (randomization) is 50percent or less than visit 1 (screening)
    Description

    Pvr > 250 ml, measured during screening phase and the randomization visit

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3839465
    UMLS CUI [1,2]
    C4060656
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    Similar models

    Eligibility Bladder Dysfunction in MS NCT00913510

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Informed consent
    Item
    provision of informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Gender and age
    Item
    male and female patients aged 18 years and over
    boolean
    C0079399 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    ms patients that are already currently treated or eligible for treatment with anticholinergic drugs
    Item
    ms patients that are already currently treated or eligible for treatment with anticholinergic drugs
    boolean
    C0026769 (UMLS CUI [1,1])
    C2827774 (UMLS CUI [1,2])
    C0242896 (UMLS CUI [1,3])
    C0026769 (UMLS CUI [2,1])
    C1548635 (UMLS CUI [2,2])
    C0242896 (UMLS CUI [2,3])
    Previous confirmation of ms according to mcdonald criteria and level of disability less than 6.5 on the kutzke scale, current stable status for 6 months
    Item
    patient with previously confirmed multiple sclerosis according to mcdonald criteria and level of disability less than 6.5 on the kutzke scale and have been stable for 6 months
    boolean
    C0026769 (UMLS CUI [1,1])
    C0679228 (UMLS CUI [1,2])
    C0012605 (UMLS CUI [2,1])
    C0451246 (UMLS CUI [2,2])
    C0521116 (UMLS CUI [3,1])
    C0205360 (UMLS CUI [3,2])
    Presence of bladder symptoms such as urgency, frequency, incontinence, nocturia, pvr
    Item
    the patient has all or any bladder symptoms; urgency, frequency, incontinence, nocturia, pvr
    boolean
    C1457887 (UMLS CUI [1,1])
    C0232841 (UMLS CUI [1,2])
    C0085606 (UMLS CUI [2])
    C2584336 (UMLS CUI [3])
    C0042024 (UMLS CUI [4])
    C0028734 (UMLS CUI [5])
    C0429774 (UMLS CUI [6,1])
    C1439885 (UMLS CUI [6,2])
    Frequency symptoms > 8 voiding per 24h
    Item
    the patient has frequency symptoms > 8 voiding per 24 h
    boolean
    C2584336 (UMLS CUI [1])
    pvr > 50 ml, measured during screening phase and the randomization visit
    Item
    the patient has pvr > 50 ml, measured at two repetitive bladder scan measurements during the screening phase as well as the randomization visit
    boolean
    C3839465 (UMLS CUI [1,1])
    C4060656 (UMLS CUI [1,2])
    Adequate mobility to lower limbs, sufficient hand function and ability to practice cic
    Item
    adequate mobility to lower limbs, sufficient hand function and ability to practice cic at least three times daily
    boolean
    C0231434 (UMLS CUI [1,1])
    C0018563 (UMLS CUI [1,2])
    C0231434 (UMLS CUI [2,1])
    C1140621 (UMLS CUI [2,2])
    C0085732 (UMLS CUI [3,1])
    C2936294 (UMLS CUI [3,2])
    Item Group
    C0680251 (UMLS CUI)
    Pregnancy
    Item
    pregnancy
    boolean
    C0032961 (UMLS CUI [1])
    Urinary tract infection
    Item
    ongoing symptomatic urinary tract infection (uti) as judged by investigator
    boolean
    C0042029 (UMLS CUI [1])
    Involvement in planning and conduct of the study
    Item
    involvement in the planning and conduct of the study (applies to both astra tech staff or staff at the study site)
    boolean
    C2603343 (UMLS CUI [1,1])
    C0851286 (UMLS CUI [1,2])
    Practice of cic prior to the study
    Item
    the patient practices cic prior the study
    boolean
    C1514463 (UMLS CUI [1,1])
    C2936294 (UMLS CUI [1,2])
    Status post sphincterectomy
    Item
    the patient has undergone a sphincterectomy
    boolean
    C1262069 (UMLS CUI [1])
    Progressive relapsing- remitting ms
    Item
    progressive "relapsing- remitting ms" as judged by the investigator
    boolean
    C1335499 (UMLS CUI [1,1])
    C0751967 (UMLS CUI [1,2])
    Severe non-compliance to protocol
    Item
    severe non-compliance to protocol as judged by the investigator and/or astra tech
    boolean
    C0457432 (UMLS CUI [1,1])
    C2348563 (UMLS CUI [1,2])
    Concurrent participation in other study that might have an impact on the outcome of this, as judged by investigator
    Item
    the patient is participating in other study that might have an impact on the outcome of this, as judged by investigator
    boolean
    C2348568 (UMLS CUI [1,1])
    C4054723 (UMLS CUI [1,2])
    Pvr > 250 ml, measured during screening phase and the randomization visit
    Item
    pvr > 250 ml, measured at two repetitive bladder scan measurements during the screening phase as well as the randomization visit and or if bladder voiding efficiency (bve) at visit 2 (randomization) is 50percent or less than visit 1 (screening)
    boolean
    C3839465 (UMLS CUI [1,1])
    C4060656 (UMLS CUI [1,2])
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