UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052675 |
|---|---|
| Receipt number | R000060090 |
| Scientific Title | Developing a self-massage method of pelvic floor muscles for adults women with subjective urinary incontinence: Mixed methods research |
| Date of disclosure of the study information | 2023/11/02 |
| Last modified on | 2023/11/02 08:19:02 |
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Basic information
Public title
Developing a self-massage method of pelvic floor muscles for adults women with subjective urinary incontinence: Mixed methods research
Acronym
Developing a self-massage method of pelvic floor muscles for adults women with subjective urinary incontinence: Mixed methods research
Scientific Title
Developing a self-massage method of pelvic floor muscles for adults women with subjective urinary incontinence: Mixed methods research
Scientific Title:Acronym
Developing a self-massage method of pelvic floor muscles for adults women with subjective urinary incontinence: Mixed methods research
Region
| Japan |
Condition
Condition
stress urinary incontinence
Classification by specialty
| Urology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study is aimed to conduct to examine the effects of a self-massage program for the pelvic floor muscles provided remotely for adult women with symptoms of stress urinary incontinence and to identify areas or points for improvement in program content and instrument with the semi-structured individual interviews in order to develop a feasible a self-massage program can be continued.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in the total score of the International Consultation on Incontinence Questionnaire-Short Form Japanese version will be the primary evaluation indicator. Surveys will be conducted two weeks prior to the start of the intervention, at the start of the intervention, and at 4 weeks, 8 weeks, and 12 weeks after the start of the intervention.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Implement a self-massage program for the pelvic floor muscles provided remotely, with a frequency of 1 to 3 minutes per day, at least 5 times a week, for 12 weeks.
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
| 20 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Female
Key inclusion criteria
- Those who responded to the question, "When does urine leak?" in the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) with either one or both of the following responses: "Leak when coughing or sneezing" and "Leak when moving the body or exercising."
- Individuals who experience the above symptoms at least once a week.
- Individuals who have a computer, smartphone, or tablet with an internet connection for conducting online meetings using a webcam.
Key exclusion criteria
- Individuals receiving treatment for urinary incontinence at a medical facility.
- Individuals diagnosed with pelvic organ prolapse.
- Individuals who are currently pregnant or within six months postpartum.
- Individuals with urinary dysfunction due to neurological disorders.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Ai |
| Middle name | |
| Last name | Shibata |
Organization
University of Tsukuba
Division name
Institute of Health and Sport Sciences
Zip code
112-0012
Address
3-29-1 Otsuka, Bunkyo-ku, Tokyo
TEL
03-3942-6455
shibata.ai.ga@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Aki |
| Middle name | |
| Last name | Onishi |
Organization
University of Tsukuba
Division name
Graduate School of Comprehensive Human Sciences
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3961
Homepage URL
onishi.aki.xd@alumni.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
without
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
Tel
029-853-2571
tg-kenkyurinri@un.tsukuba.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
| 2023 | Year | 11 | Month | 02 | 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
44
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
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 29 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 02 | Day |
Last modified on
| 2023 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060090
