UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054219 |
|---|---|
| Receipt number | R000061911 |
| Scientific Title | A study to verify the frequency of urinary incontinence of a program to improve pelvic floor muscle function for postpartum urinary incontinence patients using women's underwear with a pelvic floor muscle group voluntary response promotion function. |
| Date of disclosure of the study information | 2024/05/02 |
| Last modified on | 2024/05/01 14:31:13 |
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Basic information
Public title
A study to verify the frequency of urinary incontinence of a program to improve pelvic floor muscle function for postpartum urinary incontinence patients using women's underwear with a pelvic floor muscle group voluntary response promotion function.
Acronym
A study to verify the frequency of urinary incontinence of a program to improve pelvic floor muscle function for postpartum urinary incontinence patients using women's underwear with a pelvic floor muscle group voluntary response promotion function.
Scientific Title
A study to verify the frequency of urinary incontinence of a program to improve pelvic floor muscle function for postpartum urinary incontinence patients using women's underwear with a pelvic floor muscle group voluntary response promotion function.
Scientific Title:Acronym
Verifying the effect of using shorts that promote voluntary response of the pelvic floor muscles on the frequency of urinary incontinence in women with postpartum urinary incontinence
Region
| Japan |
Condition
Condition
Those who have stress urinary incontinence (Stress UI; SUI) at least once a week within 4 to 18 months after giving birth
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop underwear that enhances the voluntary response of the pelvic floor muscles and a pelvic floor muscle training program during postpartum childcare, and to verify changes in SUI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective urinary incontinence symptoms/QOL [International Consultation on Incontinence Questionnaire-Short Form; ICIQ-SF]
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Those who have had SUI at least once a week within 4 to 18 months after giving birth. The target number of people is 10 people.
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
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
Among the questions on the ICIQ-SF, when asked, ``When do you leak urine?'', answer either ``when you cough or sneeze'', ``when you move your body or exercise'', or Among those who selected both and answered that they have the symptoms at least once a week, those who have a device connected to the Internet environment
Key exclusion criteria
ersons with symptoms of cystitis, pyelonephritis, or pubic symphysis dissection
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | OKA |
| Middle name | |
| Last name | KOUICHIROU |
Organization
Waseda University
Division name
Faculty of Sports Science
Zip code
359-1192
Address
2-579-15 Mikashima, Tokorozawa City, Saitama Prefecture
TEL
0429-47-4614
k-araki@aoni.waseda.jp
Public contact
Name of contact person
| 1st name | ARAKI |
| Middle name | |
| Last name | KUNIKO |
Organization
Waseda University
Division name
Faculty of Sports Science
Zip code
359-1192
Address
2-579-15 Mikashima, Tokorozawa City, Saitama Prefecture
TEL
090-6704-0737
Homepage URL
k-araki@aoni.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
MIC Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Koichiro Oka Laboratory, Faculty of Sports Science, Waseda University
Address
2-579-15 Mikashima, Tokorozawa City, Saitama Prefecture
Tel
0429-47-4614
k-araki@aoni.waseda.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
| 2024 | Year | 05 | 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
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
| 2024 | Year | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 22 | Day |
Last modified on
| 2024 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061911
