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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License

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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