UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057414 |
|---|---|
| Receipt number | R000065600 |
| Scientific Title | Effects of improved urinary pads in preventing the occurrence or worsening of Incontinence Associated Dermatitis |
| Date of disclosure of the study information | 2025/03/27 |
| Last modified on | 2025/03/26 17:06:20 |
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Basic information
Public title
Skin observation study of senior people using urinary pads
Acronym
Skin observation study of senior people using urinary pads
Scientific Title
Effects of improved urinary pads in preventing the occurrence or worsening of Incontinence Associated Dermatitis
Scientific Title:Acronym
Effects of improved urinary pads in preventing the occurrence or worthening of Incontinence Associated Dermatitis
Region
| Japan |
Condition
Condition
Incontinence associated dermatitis
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To confirm the impact of the function and structure of urinary pads on preventing the occurrence or worsening of IADs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Severity rating score for incontinence associated dermatitis after two weeks of product use.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The patient's usual urine pads will be changed to the test product and used for a period of 2 weeks.
Interventions/Control_2
Use a urinary pad that differs only in surface sheet from the test product for 2 weeks.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who wear tape diapers and urine pads throughout the day.
Facility residents requiring nursing care 3 or more
Key exclusion criteria
Persons who have been instructed by a physician not to participate in the study due to illness or other reasons.
Those who are taking or will take or will take topical antibiotics or antifungal drugs.
Those who are judged by the principal investigator to be inappropriate as research subjects.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Yotsuya |
Organization
University of Fukui
Division name
Division of Nursing, Faculty of Medical Sciences
Zip code
9101193
Address
23-3 Matsuoka Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui 910-1193, Japan
TEL
0776-61-3111
jyotsuya@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Miku |
| Middle name | |
| Last name | Aoki |
Organization
University of Fukui
Division name
Division of Nursing, Faculty of Medical Sciences
Zip code
9101193
Address
23-3 Matsuoka Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui 910-1193, Japan
TEL
0776-61-3111
Homepage URL
m-aoki@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Fukui
Address
23-3 Matsuoka Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui 910-1193, Japan
Tel
0776-61-3111
rinsho-rinri@ml.u-fukui.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
| 2025 | Year | 03 | Month | 27 | 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
| 2024 | Year | 11 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | 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 | 03 | Month | 26 | Day |
Last modified on
| 2025 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065600
