UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023169 |
|---|---|
| Receipt number | 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 17:35:43 |
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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
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
y.kajiwara@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026707
