UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of behavioral self-management intervention on female urinary incontinence patients
Acronym	Effectiveness of behavioral self-management intervention on female urinary incontinence patients
Scientific Title	Effectiveness of behavioral self-management intervention on female urinary incontinence patients
Scientific Title:Acronym	Effectiveness of behavioral self-management intervention on female urinary incontinence patients
Region	Japan

Condition
Condition	urinary incontinence
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Conducting a longitudinal study to examine the effects of a behavioral intervention for female patients with urinary incontinence, which can be easily implemented in an outpatient clinic.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	urinary incontinence symptoms
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Questionnaire survey, physical function test, Behavior modification counseling, self-monitoring
Interventions/Control_2	Questionnaire survey, physical function test
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	20 years-old <=
Age-upper limit	75 years-old >
Gender	Female
Key inclusion criteria	Urinary incontinence patients who are under treatment and whose attending physician judges that behavioral modification of lifestyle behaviors will help improve their urinary incontinence symptoms. Patients who have given their written consent to participate in this study, after receiving sufficient explanation and with full understanding.
Key exclusion criteria	Patients who are having difficulty exercising or receiving physical function tests are not eligible. (Attending physician's judgment) Patients who are inappropriate to participate in this study are not eligible. (The study investigators' judgment).
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Sakurako Middle name Last name Ito
Organization	Fujita Health University
Division name	Graduate School of Health Sciences
Zip code	4701192
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL	0562932539
Email	sacra110@fujita-hu.ac.jp

Public contact
Name of contact person	1st name Sakurako Middle name Last name Ito
Organization	Fujita Health University
Division name	Graduate School of Health Sciences
Zip code	4701192
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL	0562932539
Homepage URL
Email	sacra110@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University Graduate School of Health Sciences
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science, Grants-in-Aid for Scientific Research
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	Fujita Health University
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
Tel	0562-93-2000
Email	crb-f@fujita-hu.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 11 Month 20 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	2021 Year 11 Month 09 Day
Date of IRB	2021 Year 11 Month 12 Day
Anticipated trial start date	2021 Year 11 Month 29 Day
Last follow-up date	2026 Year 03 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 11 Month 17 Day
Last modified on	2021 Year 11 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052629