UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055117 |
|---|---|
| Receipt number | R000062964 |
| Scientific Title | Assessment of Pelvic Floor Muscle Function of Middle-aged and Elder Women Between Sitting and Supine Position Using Ultrasound Diagnosis |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2025/02/03 12:48:24 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Assessment of Pelvic Floor Muscle Function of Middle-aged and Elder Women Between Sitting and Supine Position Using Ultrasound Diagnosis
Acronym
Assessment of Pelvic Floor Muscle Function of Middle-aged and Elder Women Between Sitting and Supine Position Using Ultrasound Diagnosis
Scientific Title
Assessment of Pelvic Floor Muscle Function of Middle-aged and Elder Women Between Sitting and Supine Position Using Ultrasound Diagnosis
Scientific Title:Acronym
Assessment of Pelvic Floor Muscle Function of Middle-aged and Elder Women Between Sitting and Supine Position Using Ultrasound Diagnosis
Region
| Japan |
Condition
Condition
Stress Urinary Incontinence
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assessment of pelvic floor muscle function of middle-aged and elder women between sitting and supine position using ultrasound diagnosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pelvic Floor Muscle Function
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 40 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Female
Key inclusion criteria
Woman who can contract her pelvic floor muscle
Key exclusion criteria
Woman who consult a doctor about urinary incontinence/ Woman who is urgency urinary incontinence/ Woman who underwent an abdominal surgery/ Woman who is pregnancy or had a delivery within a year/ Woman who has cerebrovascular accident or neurological disorders/ Woman whose body mass index is over 35/ Woman who is an expert of pelvic floor muscle training/ Woman who can`t understand Japanese
Target sample size
128
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
305-8575
Address
1-1-1, Tennoudai, Tsukuba, Ibaraki
TEL
029-853-3013
okayama@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Koishikawa |
Organization
University of Tsukuba
Division name
Comprehensive Human Science, Nursing Science
Zip code
305-8575
Address
1-1-1, Tennoudai, Tsukuba, Ibaraki
TEL
029-853-3013
Homepage URL
s2321376@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Management Expenses Grants
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
1-1-1, Tennoudai, Tsukuba, Ibaraki
Tel
029-853-3013
s2321376@u.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 | 08 | 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
130
Results
The bladder base displacement was larger in the incontinent group than in the continent group.
Results date posted
| 2025 | Year | 02 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants were 130 women, which age were 40-79 years old.
Participant flow
Participants applied the research using QRcode.
Adverse events
No adverse event
Outcome measures
Pelvic floor muscle function
Bladder base displacement
Time
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 01 | Month | 20 | Day |
Date analysis concluded
| 2025 | Year | 01 | Month | 20 | Day |
Other
Other related information
Measure bladder base displacement and duration using ultrasound diagnosis and max strength of pelvic floor muscle contraction and duration using a pelvic floor muscle trainer.
Management information
Registered date
| 2024 | Year | 07 | Month | 30 | Day |
Last modified on
| 2025 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062964
