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UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023169
Receipt No. R000026707
Scientific Title The relationship between urinary incontinence and hip function in female patients undergoing total hip arthroplasty
Date of disclosure of the study information 2016/07/14
Last modified on 2016/07/14

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Basic information
Public title The relationship between urinary incontinence and hip function in female patients undergoing total hip arthroplasty
Acronym The relationship between urinary incontinence and hip function in female patients undergoing total hip arthroplasty
Scientific Title The relationship between urinary incontinence and hip function in female patients undergoing total hip arthroplasty
Scientific Title:Acronym The relationship between urinary incontinence and hip function in female patients undergoing total hip arthroplasty
Region
Japan

Condition
Condition hip osteoarthritis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess is which hip function related with urinary incontinence before and after surgery.
Basic objectives2 Others
Basic objectives -Others To study what hip function is related with urinary incontinence.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes hip muscle strength, symptom of urinary incontinence (before surgery, at 3 weeks after surgery, at 3 months after surgery)
Key secondary outcomes physical activity, health-related QOL

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria The patients who will undergo total hip arthroplasty by hip osteoarthritis.
Key exclusion criteria The patient with urinary incontinence as a result of neurogenic bladder.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kajiwara Yu
Organization Kio University
Division name Faculty of Health Science
Zip code
Address 4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
TEL 0745-54-1601
Email y.kajiwara@kio.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kajiwara Yu
Organization Kio University
Division name Faculty of Health Science
Zip code
Address 4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
TEL 0745-54-1601
Homepage URL
Email y.kajiwara@kio.ac.jp

Sponsor
Institute Kio University
Institute
Department

Funding Source
Organization Kio University
Organization
Division
Category of Funding Organization Other
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 香芝旭ヶ丘病院(奈良県),西の京病院(奈良県)

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 14 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
2016 Year 07 Month 17 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To assess the symptom of urinary incontinence, hip function, physical activity, health-related QOL in women undergoing total hip arthroplasty before surgery, at 3 weeks and 3 months after surgery.

Management information
Registered date
2016 Year 07 Month 14 Day
Last modified on
2016 Year 07 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026707

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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