UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057616 |
|---|---|
| Receipt number | R000065832 |
| Scientific Title | A study on the effectiveness of Smart-Diaper in supporting independent urination |
| Date of disclosure of the study information | 2025/04/15 |
| Last modified on | 2025/04/15 13:05:53 |
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Basic information
Public title
A study on the effectiveness of Smart-Diaper in supporting independent urination
Acronym
A study on the effectiveness of Smart-Diaper in supporting independent urination
Scientific Title
A study on the effectiveness of Smart-Diaper in supporting independent urination
Scientific Title:Acronym
A study on the effectiveness of Smart-Diaper in supporting independent urination
Region
| Japan |
Condition
Condition
dysuria
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will use KOYO Co., Ltd.'s Diaper Navi (adult diaper sensor) (on sale from May 2024) to examine whether the system can reduce the effort required for care to support independent urination, and whether it can lead to more efficient use of labor and human and material resources.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The main evaluation item was the degree of contribution to reducing the number and duration of interventions in independent living support (work burden).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Wear a diaper with a sensor attached.
Interventions/Control_2
Manage with conventional diapers.
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
Patients admitted to our hospital who are showing a tendency towards cognitive decline. In particular, patients who have had cerebrovascular disease (after surgery for chronic subdural hematoma, cerebral hemorrhage, or cerebral infarction) or trauma (mainly fractures due to falls) and who have required urinary catheter management in our hospital's neurosurgery, internal medicine, or orthopedic wards.
Key exclusion criteria
Patients who are minors or who the principal investigator judges to be inappropriate for research subjects for other reasons
Patients who are in a state of chronic renal failure and whose daily urine output is estimated to be less than 500 ml
Patients who have a urinary catheter in place due to severe urinary problems that existed before hospitalization or surgery
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hirai |
| Middle name | |
| Last name | Kotaro |
Organization
National Hospital Organization Yokohama Medical Center
Division name
Department of Urology
Zip code
2458575
Address
Kanagawa Prefecture, Yokohama City, Totsuka Ward, Harajuku 3-60-2
TEL
0458512621
kohirai2002@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hirai |
| Middle name | |
| Last name | Kotaro |
Organization
National Hospital Organization Yokohama Medical Center
Division name
Department of Urology
Zip code
2360024
Address
Kanagawa Prefecture, Yokohama City, Totsuka Ward, Harajuku 3-60-2
TEL
09034396234
Homepage URL
kohirai2002@yahoo.co.jp
Sponsor or person
Institute
National Hospital Organization Yokohama Medical Center ,Clinical Research Department
Institute
Department
Personal name
Funding Source
Organization
none
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 Yokohama Medical Center IRB
Address
Kanagawa Prefecture, Yokohama City, Totsuka Ward, Harajuku 3-60-2
Tel
0458512621
kohirai2002@yahoo.co.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
| 2025 | Year | 04 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | 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
Management information
Registered date
| 2025 | Year | 04 | Month | 15 | Day |
Last modified on
| 2025 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065832
