UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035314 |
|---|---|
| Receipt number | R000039839 |
| Scientific Title | Smartphone application for managing urinary incontinence |
| Date of disclosure of the study information | 2019/01/01 |
| Last modified on | 2020/12/25 14:28:07 |
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Basic information
Public title
Smartphone application for managing urinary incontinence
Acronym
Smartphone application for managing urinary incontinence
Scientific Title
Smartphone application for managing urinary incontinence
Scientific Title:Acronym
Smartphone application for managing urinary incontinence
Region
| Japan |
Condition
Condition
Urinary incontinence
Classification by specialty
| Obstetrics and Gynecology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effect of smartphone application software; app for improving urinary incontinence on pelvic floor muscle training adherence. We also follow-up urinary incontinence women using app for 8 weeks and investigate the usability and adverse events of the app after use.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adherence of PFMT
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The participants perform pelvic floor muscle training combined the app for 8 weeks.
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
Female
Key inclusion criteria
Women with urinary incontinence instructed pelvic floor muscle training, also, women who will continue to use the app for 8 weeks.
Inclusion criteria
24 hour pad test 1.3 g or more and total score of ICIQ-SF is 1 or more.
Key exclusion criteria
Exclusion criteria
Neurological disorders of urinary function and cognitive disorders.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaori Kinouchi |
Organization
Osaka University graduate school of medicine
Division name
Health science area of nursing science
Zip code
Address
1-7-B411 Yamadaoka Suita Osaka
TEL
0668792537
kinouchi@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaori Kinouchi |
Organization
Osaka university graduate of medicine
Division name
Health science area of nursing science
Zip code
Address
Yamadaoka 1-7-B411
TEL
0668792537
Homepage URL
kinouchi@sahs.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka university graduate of medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2019 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
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
| 2018 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2020 | 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
| 2018 | Year | 12 | Month | 19 | Day |
Last modified on
| 2020 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039839
