UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049421 |
|---|---|
| Receipt number | R000056231 |
| Scientific Title | Challenges of independent urination support for stroke patients in our hospital |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2022/11/03 21:49:43 |
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Basic information
Public title
Challenges of independent urination support for stroke patients in our hospital
Acronym
Challenges of independent urination support for stroke patients in our hospital
Scientific Title
Challenges of independent urination support for stroke patients in our hospital
Scientific Title:Acronym
Challenges of independent urination support for stroke patients in our hospital
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In fiscal 2021, we will start supporting independent urination for stroke patients.
Grasp the current situation and consider necessary future efforts
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Support for independent urination in 2021
In Japan, the average duration of urinary catheterization was 10.3 days, and the average incidence of febrile urinary tract infections was 4.
Five%
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Understanding the current situation before urination support intervention from September 2021 to March 2022
Interventions/Control_2
Understanding the current situation before urination support intervention from September 2021 to March 2022
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 60 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Exhaustion in stroke patients
Patients for whom urinary independence support addition is calculated.
Key exclusion criteria
Other than those above
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | ogawa |
| Middle name | |
| Last name | sayako |
Organization
Higashihiroshima Medical Center
Division name
4 wards
Zip code
739-0041
Address
513 Jike, Saijo-cho, Higashi-Hiroshima City, Hiroshima Prefecture
TEL
082-423-2176
ogawa.sayako.py@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | ogawa |
| Middle name | |
| Last name | sayako |
Organization
Higashihiroshima Medical Center
Division name
4 wards
Zip code
739-0041
Address
513 Jike, Saijo-cho, Higashi-Hiroshima City, Hiroshima Prefecture
TEL
082-423-2176
Homepage URL
ogawa.sayako.py@mail.hosp.go.jp
Sponsor or person
Institute
Ministry of Health, Labour and Welfare
Institute
Department
Personal name
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Higashihiroshima Medical Center
Address
513 Jike, Saijo-cho, Higashi-Hiroshima City, Hiroshima Prefecture
Tel
082-423-2176
ogawa.sayako.py@mail.hosp.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 03 | Day |
Last modified on
| 2022 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056231
