UMIN-CTR Clinical Trial

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
Email	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
Email	yamashita.nobuhito.kw@mail.hosp.go.jp

Sponsor
Institute	National Hospital Organization Higashi-Hiroshima Medical Center
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056120