UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055979 |
|---|---|
| Receipt number | R000063943 |
| Scientific Title | Verification of the effect of the gluteus maximus muscle training with electrical stimulation on the pelvic floor muscles. |
| Date of disclosure of the study information | 2024/10/30 |
| Last modified on | 2025/11/04 10:06:34 |
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Basic information
Public title
Verification of the effect of the gluteus maximus muscle training with electrical stimulation on the pelvic floor muscles.
Acronym
Verification of the effect of the gluteus maximus muscle training with electrical stimulation on the pelvic floor muscles.
Scientific Title
Verification of the effect of the gluteus maximus muscle training with electrical stimulation on the pelvic floor muscles.
Scientific Title:Acronym
Verification of the effect of the gluteus maximus muscle training with electrical stimulation on the pelvic floor muscles.
Region
| Japan |
Condition
Condition
Healthy women in their 30s to 50s who have delivered before
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test, as a pilot study, whether electrical stimulation of the gluteus maximus muscle using Hip Fit strengthens the pelvic floor muscle group.
Basic objectives2
Others
Basic objectives -Others
Verification of Action
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pelvic floor muscle measurements (pelvic floor muscle contraction force and pelvic floor muscle contraction time)
The evaluation periods will be pre-intervention, 6 weeks post-intervention, and 12 weeks post-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
Uncontrolled
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
The study subjects will wear the SIXPAD Hip Fit.
The intervention period will be 12 weeks and will be worn daily for 23 minutes.
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
Healthy women in their 30s to 50s who have delivered before
Key exclusion criteria
Those who have received treatment for pelvic organs or urinary incontinence at a medical institution.
Persons with electromagnetic hypersensitivity (physical symptoms such as headache, dizziness, nausea, etc., caused by the use of electrical appliances such as cell phones, computers, wireless LAN, induction cookers, microwave ovens, etc.)
Pacemaker users
Those who have a history of pelvic organ prolapse or pelvic organ abdominal surgery (excluding cesarean section)
Pregnant women and women within 1 year postpartum
Patients with urinary incontinence due to neurological disorders
Patients with a history of cerebrovascular disease or neurological disease.
Those who are out of the standard size range of Hip Fit.
Those who are undergoing pelvic floor muscle training.
Those who have difficulty communicating in Japanese or answering questionnaires.
Those who have difficulty in coming to the hospital for pelvic floor muscle measurement on the designated date.
Those who have contraindications to the use of Hip Fit and those who need to consult a physician.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Hisayo |
| Middle name | |
| Last name | Okayama |
Organization
University of Tsukuba
Division name
Institute of Medicine
Zip code
305-8577
Address
1-1-1 Tennodai, Tsukuba City, Ibaraki, Japan
TEL
029-853-8372
okayama@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Hisayo |
| Middle name | |
| Last name | Okayama |
Organization
University of Tsukuba
Division name
Institute of Medicine
Zip code
305-8577
Address
1-1-1 Tennodai, Tsukuba City, Ibaraki, Japan
TEL
029-853-8372
Homepage URL
okayama@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
MTG Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka Medical and Pharmaceutical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba City, Ibaraki, Japan
Tel
029-853-8372
sien.ningenss@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
| 2024 | Year | 10 | Month | 30 | 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
Completed
Date of protocol fixation
| 2024 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 29 | Day |
Last modified on
| 2025 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063943
