UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054027 |
|---|---|
| Receipt number | R000061679 |
| Scientific Title | Duration of pelvic floor muscle training and subjective achievement |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/04/01 15:14:13 |
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Basic information
Public title
How long does pelvic floor muscle contraction from pelvic floor muscle training last?
Acronym
Duration of pelvic floor muscle contraction
Scientific Title
Duration of pelvic floor muscle training and subjective achievement
Scientific Title:Acronym
Pelvic floor muscle training duration
Region
| Japan |
Condition
Condition
Healthy Person
Classification by specialty
| Urology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identify the length of time that one pelvic floor muscle training session can maintain the learned skill.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pelvic floor muscle elevation: before instruction, after instruction, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 10 days, 14 days
Key secondary outcomes
Subjective Achievement (Questionnaire)
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
| Maneuver |
Interventions/Control_1
Instruction on how to contract pelvic floor muscles and home exercises for pelvic floor muscles
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
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy woman
Key exclusion criteria
Transplants, pregnant women, those with a history of orthopedic disease or surgery in the lower extremities or trunk, those with urologic or neuromuscular disease, peripheral neuropathy, or central nervous system disease, and those who have previously undergone pelvic floor muscle training.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hitomi |
| Middle name | |
| Last name | Handa |
Organization
TRIGGER Corporation
Division name
TRIGGER Research and Development Division
Zip code
1070052
Address
201,7-6-9, Akasaka, Minato-ku, Tokyo
TEL
03-5545-5859
info@trigger-physio.com
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Handa |
Organization
TRIGGER Corporation
Division name
TRIGGER Research and Development Division
Zip code
1070052
Address
201, 7-6-9, Akasaka, Minato-ku, Tokyo
TEL
0355455859
Homepage URL
info@trigger-physio.com
Sponsor or person
Institute
TRIGGER Corporation
Institute
Department
Personal name
Funding Source
Organization
TRIGGER Corporation
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
Ethical Committee of Sanhuan Tumor Hospital
Address
No. 352, Shilihe, Chaoyang District, Beijing, China
Tel
01067315130
shzlrsk@126.com
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 | 04 | 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
23
Results
Pelvic floor muscle elevation was significantly higher (p < 0.05) immediately after (Post) and on days 1-3 compared to the initial measurement (Pre). Self-efficacy for pelvic floor muscle contraction was significantly lower (p < 0.05) on days 7, 10 and 14 compared to Post.
Results date posted
| 2024 | Year | 04 | Month | 01 | Day |
Results Delayed
Results Delay Reason
The main reason for the delay was that it took longer than expected to collect the data needed for the study. The timeline established at the beginning of the study underestimated the length of time required to collect certain data points. In particular, limited access to research facilities due to the COVID-19 pandemic, delays in receiving information from data providers, and the need for additional processes to ensure data quality and completeness were the main reasons for the delays.
Date of the first journal publication of results
Baseline Characteristics
Health woman
Participant flow
Explanation of experiment, initial measurement, pelvic floor muscle training instruction, measurement after instruction, measurement after 1 day, measurement after 2 days, measurement after 3 days, measurement after 4 days, measurement after 5 days, measurement after 6 days, measurement after 7 days, measurement after 10 days, measurement after 14 days
Adverse events
none
Outcome measures
Pelvic floor muscle elevation
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 01 | 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 | 01 | Day |
Last modified on
| 2024 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061679
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
