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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035314
Receipt No. R000039839
Scientific Title Smartphone application for managing urinary incontinence
Date of disclosure of the study information 2019/01/01
Last modified on 2018/12/19

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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
Obsterics 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
Email 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
Email kinouchi@sahs.med.osaka-u.ac.jp

Sponsor
Institute Osaka university graduate of medicine
Institute
Department

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
Email

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 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
2018 Year 12 Month 12 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 12 Day
Last follow-up date
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
2018 Year 12 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039839

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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