UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046102 |
|---|---|
| Receipt number | R000052629 |
| Scientific Title | Effectiveness of behavioral self-management intervention on female urinary incontinence patients |
| Date of disclosure of the study information | 2021/11/20 |
| Last modified on | 2021/11/18 10:44:12 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
sacra110@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Graduate School of Health Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052629
