UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049282 |
|---|---|
| Receipt number | R000056120 |
| Scientific Title | Effects of urinary independence support for stroke patients by a urination care team |
| Date of disclosure of the study information | 2022/10/24 |
| Last modified on | 2022/10/21 09:32:09 |
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Basic information
Public title
Effects of urinary independence support for stroke patients by a urination care team
Acronym
Effects of urinary independence support for stroke patients by a urination care team
Scientific Title
Effects of urinary independence support for stroke patients by a urination care team
Scientific Title:Acronym
Effects of urinary independence support for stroke patients by a urination care team
Region
| Japan |
Condition
Condition
STROKE
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In 2022, our hospital began full-scale support for independent urination for stroke patients. Comparing 2021 and 2022, we consider and report the effect of providing urinary independence support for stroke patients.
Basic objectives2
Others
Basic objectives -Others
In 2022, our hospital began full-scale support for independent urination for stroke patients. Comparing 2021 and 2022, we consider and report the effect of providing urinary independence support for stroke patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Supporting independent urination in stroke patients shortened the average duration of urinary catheter placement and reduced the incidence of febrile urinary tract infections. In addition, urinary independence and lower urinary tract function improved. It was suggested that support for independent micturition in stroke patients shortens the duration of indwelling bladder catheterization and reduces the incidence of febrile urinary tract infections. In addition, improvement of lower urinary tract functions such as incontinence and urinary retention may have a positive impact on the patient's QOL.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Target period: From September 2021 to the end of July 2022. Target patients: 35 stroke patients for whom the addition of independent urination support was calculated
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Stroke patients who calculated the addition of independent urination support
Key exclusion criteria
none
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Nobuhito |
| Middle name | |
| Last name | Yamashita |
Organization
National Hospital Organization Higashi-Hiroshima Medical Center
Division name
nursing department
Zip code
739-0041
Address
Hiroshimaken higashihirosimashi saijoutyoujike 513
TEL
082-423-2176
yamashita.nobuhito.kw@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Nobuhito |
| Middle name | |
| Last name | Yamashita |
Organization
National Hospital Organization Higashi-Hiroshima Medical Center
Division name
nursing department
Zip code
739-0041
Address
Hiroshimaken higashihirosimashi saijoutyoujike 513
TEL
082-423-2176
Homepage URL
yamashita.nobuhito.kw@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Higashi-Hiroshima Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Higashi-Hiroshima Medical Center
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
National Hospital Organization Higashi-Hiroshima Medical Center
Address
Hiroshimaken higashihirosimashi saijoutyoujike 513
Tel
082-423-2176
yamashita.nobuhito.kw@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
| 2022 | Year | 10 | Month | 24 | 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
35
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
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 21 | 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 | 10 | Month | 21 | Day |
Last modified on
| 2022 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056120
