UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056260 |
|---|---|
| Receipt number | R000062918 |
| Scientific Title | The effect of different methods of instructing voluntary contraction of the pelvic floor muscles on the amount of pelvic floor elevation |
| Date of disclosure of the study information | 2024/11/25 |
| Last modified on | 2025/11/26 09:26:48 |
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Basic information
Public title
The effect of different methods of instructing voluntary contraction of the pelvic floor muscles on the amount of pelvic floor elevation
Acronym
The effect of different methods of instructing voluntary contraction of the pelvic floor muscles on the amount of pelvic floor elevation
Scientific Title
The effect of different methods of instructing voluntary contraction of the pelvic floor muscles on the amount of pelvic floor elevation
Scientific Title:Acronym
The effect of different methods of instructing voluntary contraction of the pelvic floor muscles on the amount of pelvic floor elevation
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This was a randomized controlled trial aimed to verify the effect of different methods of instructing pelvic floor muscle contraction on the amount of pelvic floor lift.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pelvic floor elevation and elevation rate by ultrasound imaging
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
"Echo group": Surface palpation of the pelvic floor muscles + feedback using an ultrasound imaging diagnostic device via the transabdominal method
Interventions/Control_2
"Control group": Surface palpation of the pelvic floor muscles only
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Healthy women aged 40 or older who agreed to participate in this study
Key exclusion criteria
Those who have received or are currently receiving professional training in PFMT within the past six months
With pelvic organ prolapse
With urinary incontinence more than twice a week
Those who have had surgery in the urogynecology field (urinary incontinence, pelvic organ prolapse, etc.)
Pregnant women
With a history of radiation therapy
With a history of total hysterectomy
With mental illness
With neurological illness
Those who are unable to understand explanations
Those currently receiving medication for lower urinary tract symptoms
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | AKIKO |
| Middle name | |
| Last name | MORI |
Organization
hyogo medical university
Division name
school of Rehabilitation
Zip code
6508530
Address
1-3-6 Minatojima ,Chuo-ku,Kobe,hyogo
TEL
78043189
moakiko@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | AKIKO |
| Middle name | |
| Last name | MORI |
Organization
HYOGO MEDICAL UNIVERSITY
Division name
school of Rehabilitation
Zip code
6508530
Address
1-3-6 minatojima chuoku kobe hyogo
TEL
78043189
Homepage URL
moakiko@hyo-med.ac.jp
Sponsor or person
Institute
HYOGO MEDICAL UNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo College of Medicine Ethics Committee
Address
1-1 Mukogawacyo, nishinomiya-shi, Hyogo
Tel
0798456066
rinri@hyo-med.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 | 11 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2024 | Year | 11 | Month | 25 | Day |
Last modified on
| 2025 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062918
