UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The relationship between urinary incontinence and hip function in female patients undergoing total hip arthroplasty
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Kajiwara Yu
Organization	Kio University
Division name	Faculty of Health Science
Address	4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
TEL	0745-54-1601
Email	y.kajiwara@kio.ac.jp

Public contact
Name of contact person	Kajiwara Yu
Organization	Kio University
Division name	Faculty of Health Science
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 07 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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