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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044384
Receipt No. R000049464
Scientific Title Effect of changes in urinary incontinence symptoms due to self-exercise on economic behavior
Date of disclosure of the study information 2021/06/02
Last modified on 2021/05/31

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Basic information
Public title Effect of changes in urinary incontinence symptoms due to self-exercise on economic behavior
Acronym Effect of changes in urinary incontinence symptoms due to self-exercise on economic behavior
Scientific Title Effect of changes in urinary incontinence symptoms due to self-exercise on economic behavior
Scientific Title:Acronym Effect of changes in urinary incontinence symptoms due to self-exercise on economic behavior
Region
Japan

Condition
Condition healthy person
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Whether the presence or absence of urinary incontinence symptoms makes a difference in economic activity
Basic objectives2 Others
Basic objectives -Others Improvement of Urinary Incontinence Symptoms Affects Quality of Life and Economic Activity
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ICIQ-SF , quality of life, physical activity, and economic behavior
Key secondary outcomes 1.Exercise frequency during the intervention period

2.History of urology-related hospital visits, medication, and treatment during the intervention period

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 Fifteen-minute exercises, focusing on pelvic floor muscles exercises, three times a week
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Those who are 40 years old or older at the time of obtaining informed consent and reside in Hiroshima Prefecture
2. Those who can provide written informed consent for this study
Key exclusion criteria 1. Patients who are undergoing urological treatment or medication at the time of obtaining informed consent
2. Those who are pregnant
3. Others who are regarded as unsuitable by the researcher to conduct this research
Target sample size 250

Research contact person
Name of lead principal investigator
1st name Maeda
Middle name
Last name Noriaki
Organization Graduate School of Biomedical & Health Sciences, Hiroshima University
Division name Department of Sports Rehabilitation
Zip code 734-8553
Address 1-2-3,Kassumi,Minamiku,Hiroshima,Japan
TEL 082-257-5410
Email norimmi@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name Maeda
Middle name
Last name Noriaki
Organization Graduate School of Biomedical & Health Sciences, Hiroshima University
Division name Department of Sports Rehabilitation
Zip code 734-8553
Address 1-2-3,Kassumi,Minamiku,Hiroshima,Japan
TEL 082-257-5410
Homepage URL
Email norimmi@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University
Institute
Department

Funding Source
Organization Hiroshima University
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 Graduate School of Biomedical & Health Sciences, Hiroshima University
Address 1-2-3,Kassumi,Minamiku,Hiroshima,Japan
Tel 082-257-5410
Email norimmi@hiroshima-u.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
2021 Year 06 Month 02 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
2021 Year 03 Month 17 Day
Date of IRB
2021 Year 04 Month 20 Day
Anticipated trial start date
2021 Year 04 Month 21 Day
Last follow-up date
2024 Year 05 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
2021 Year 05 Month 31 Day
Last modified on
2021 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049464

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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