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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030107
Receipt No. R000034371
Scientific Title Exploratory research and effect verification of the posture acting on the pelvic floor muscles
Date of disclosure of the study information 2017/12/25
Last modified on 2019/02/05

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Basic information
Public title Exploratory research and effect verification of the posture acting on the pelvic floor muscles
Acronym Exploratory of the posture acting on the pelvic floor muscles
Scientific Title Exploratory research and effect verification of the posture acting on the pelvic floor muscles
Scientific Title:Acronym Exploratory of the posture acting on the pelvic floor muscles
Region
Japan

Condition
Condition Stress urinary incontinence
Pelvic relaxation
Classification by specialty
Urology Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore and verify methods to strengthen pelvic floor muscles by postures
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of bladder neck position using a magnetic resonance
Key secondary outcomes Success or failure of pelvic floor muscles contraction using ultrasounds
The Japanese version of International Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF)
Incontinence episodes/ week
1-hour pad test

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Pelvic floor muscle training by the posture acting on the pelvic floor muscles
Interventions/Control_2 Conventional pelvic floor muscle training
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
30 years-old <=
Age-upper limit
60 years-old >
Gender Female
Key inclusion criteria Women with stress urinary incontinence
Key exclusion criteria Pregnant
Postpartum women within the last 3 months
Women undergoing treatment for urinary incontinence
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sanae Ninomiya
Organization Kyoto University
Division name Human Hearth Science, Graduate School of Medicine
Zip code
Address 53 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507
TEL 075-751-3927
Email ninomiya.sanae.4u@kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sanae Ninomiya
Organization Kyoto University
Division name Human Hearth Science, Graduate School of Medicine
Zip code
Address 53 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507
TEL 075-751-3927
Homepage URL
Email ninomiya.sanae.4u@kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Japan society for the promotion of science
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
2017 Year 12 Month 25 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
2017 Year 10 Month 24 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 05 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
2017 Year 11 Month 24 Day
Last modified on
2019 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034371

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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