UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050968 |
|---|---|
| Receipt number | R000057981 |
| Scientific Title | Assessment of the Feasibility of a Mobile Health Application to Support Pelvic Floor Muscle Training in Postpartum Women |
| Date of disclosure of the study information | 2023/05/01 |
| Last modified on | 2025/04/07 15:32:54 |
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Basic information
Public title
Assessment of the Feasibility of a Mobile Health Application to Support Pelvic Floor Muscle Training in Postpartum Women
Acronym
Assessment of the Feasibility of a Mobile Health Application to Support Pelvic Floor Muscle Training in Postpartum Women
Scientific Title
Assessment of the Feasibility of a Mobile Health Application to Support Pelvic Floor Muscle Training in Postpartum Women
Scientific Title:Acronym
Assessment of the Feasibility of a Mobile Health Application to Support Pelvic Floor Muscle Training in Postpartum Women
Region
| Japan |
Condition
Condition
postpartum women
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The usefulness of mobile health application as a pelvic floor muscle training support tool was asess.
Basic objectives2
Others
Basic objectives -Others
Factors associated with use of mobile health application were explored.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The days performed pelvic floor muscle training and the subjective usefulness of the participants
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
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
Participants use a mobile health application to support pelvic floor muscle training for eight weeks. The application provides guidance on timing for contraction and relaxation of pelvic floor muscles via sound and vibration, and reminders with local notifications to prevent forgetting the training.
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
| Not applicable |
Gender
Female
Key inclusion criteria
Postnatal women within a year and their age is 20 years or older
Key exclusion criteria
Diabetes mellitus, urinary dysfunction, neurological disorders, the history of cancer and radiation therapy, and those considered unsuitable by the researchers were excluded.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | KINOUCHI |
| Middle name | |
| Last name | Kaori |
Organization
Osaka University Graduate school of Medicine
Division name
Department of Children and Women's Health, Area of integrated Health and Nursing Science
Zip code
5650871
Address
1-7, Yamadaoka Suita Osaka
TEL
06-6879-2537
kinouchi@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | KINOUCHI |
| Middle name | |
| Last name | Kaori |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Children and Women's Health, Area of integrated Health and Nursing Science
Zip code
5650871
Address
1-7, Yamadaoka Suita Osaka
TEL
06-6879-2537
Homepage URL
kinouchi@sahs.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
KINOUCHI Kaori
Funding Source
Organization
Japan Society for the Promotion of Science(JSPS)
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board of Osaka University Hospital
Address
2-2, Yamadaoka Suita Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.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
大阪大学医学系研究科保健学専攻（大阪府）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 14 | 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
| 2023 | Year | 05 | Month | 01 | Day |
Last modified on
| 2025 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057981
