UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060719 |
|---|---|
| Receipt number | R000069467 |
| Scientific Title | A Single-Center Retrospective Observational Study Evaluating the Implementation of Support for Independent Voiding in Inpatients in a Convalescent Rehabilitation Ward |
| Date of disclosure of the study information | 2026/02/26 |
| Last modified on | 2026/02/20 21:42:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Survey of Current Practices in the Care of Voiding Dysfunction in the Convalescent Rehabilitation Ward
Acronym
A Survey of Current Practices in the Care of Voiding Dysfunction in the Convalescent Rehabilitation Ward
Scientific Title
A Single-Center Retrospective Observational Study Evaluating the Implementation of Support for Independent Voiding in Inpatients in a Convalescent Rehabilitation Ward
Scientific Title:Acronym
A Single-Center Retrospective Observational Study Evaluating the Implementation of Support for Independent Voiding in Inpatients in a Convalescent Rehabilitation Ward
Region
| Japan |
Condition
Condition
Lower urinary tract Symptoms
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to describe the assessments and interventions implemented during the early phase of hospitalization to promote independent voiding in patients with lower urinary tract dysfunction admitted to a convalescent rehabilitation ward, and to evaluate whether these practices are consistent with current evidence-based standards of care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the extent to which interventions supporting independent voiding were implemented, assessed through documentation of the following components:
1.Identification of the need for support for independent voiding
2.Implementation of a 24-hour voiding diary and/or measurement of post-voidresidual urine volume
3.Documentation of voiding independence level and lower urinary tract functionassessment items
4.Development of a comprehensive voiding care plan, including environmentalmodifications, posture optimization, and use of assistive devices
5.Implementation of specific interventions targeting lower urinary tract function,such as bladder training or intermittent catheterization
Each component will be scored on a 3-point scale (0-2 points) based on the presence and completeness of documentation.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The research collaborators of this study will be the patient who is the recipient of care (research collaborator A) and the care of the research collaborator A.
The nurse who would have conducted the study (research collaborator B).
Study collaborator A: Patients who were admitted to the convalescent rehabilitation ward of our hospital between April 1, 2025-September 30, 2025 and discharged by December 31, 2025, have a description of symptoms related to lower urinary tract disorders at the time of admission from their medical records, and there was no refusal due to opt-out.
Research collaborator B: A nurse who belonged to the convalescent rehabilitation ward of our hospital who would have nursed the above research collaborator A between April 1, 2025-December 31, 2025, and who did not refuse due to opt-out
Key exclusion criteria
Research collaborator A: Patients who have been transferred to a hospital for treatment due to worsening of concurrent diseases or complications
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | MIDORI |
| Middle name | |
| Last name | SUNAHARA |
Organization
Ibaraki Prefectural University of Health Sciences Hospital
Division name
Nursing Management Department
Zip code
3000331
Address
4733Ami , Ami-town , Inashiki -gun,Ibaraki,Japan
TEL
029-888-9200
sunshara@ami.ipu.ac.jp
Public contact
Name of contact person
| 1st name | MIDORI |
| Middle name | |
| Last name | SUNAHARA |
Organization
Ibaraki Prefectural University of Health Sciences Hospital
Division name
Nursing Management Department
Zip code
3000331
Address
4733Ami , Ami-town , Inashiki -gun,Ibaraki,Japan
TEL
0298889200
Homepage URL
sunahara@ami.ipu.ac.jp
Sponsor or person
Institute
Ibaraki Prefectural University of Health Sciences Hospital
Institute
Department
Personal name
MIDORI SUNAHARA
Funding Source
Organization
Ibaraki Prefectural University of Health Sciences Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ibaraki Prefectural University of Health Sciences Hospital
Address
4733Ami , Ami-town , Inashiki -gun,Ibaraki,Japan
Tel
0298889200
sunahara@ami.ipu.ac.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
| 2026 | Year | 02 | Month | 26 | 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
| 2026 | Year | 02 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a single-center retrospective observational descriptive study. Electronic medical records will be reviewed to assess the implementation of evidence-based urinary dysfunction care and urinary independence support in a convalescent rehabilitation ward.
The implementation status will be evaluated according to predefined criteria and analyzed using descriptive statistics. This is a non-interventional study without allocation, randomization, or blinding and will be conducted using an opt-out consent process.
Management information
Registered date
| 2026 | Year | 02 | Month | 20 | Day |
Last modified on
| 2026 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069467
