UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056996 |
|---|---|
| Receipt number | R000065139 |
| Scientific Title | Diagnostic imaging detection of age-related fragility of the pelvic floor |
| Date of disclosure of the study information | 2025/02/12 |
| Last modified on | 2025/02/11 14:34:12 |
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Basic information
Public title
Imaging-based analysis of the pelvic floor for detecting aging signs
Acronym
Imaging diagnostic analysis of pelvic floor aging
Scientific Title
Diagnostic imaging detection of age-related fragility of the pelvic floor
Scientific Title:Acronym
Diagnostic imaging detection of age-related pelvic floor fragility
Region
| Japan |
Condition
Condition
Healthy adult female
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To diagnose the early signs of pelvic organ prolapse (POP), it is essential to detect age-related pelvic floor fragility at an early stage.
Basic objectives2
Others
Basic objectives -Others
To elucidate age-related morphological changes in the pelvic floor through imaging diagnostics, and establish an objective evaluation method for predicting pelvic organ prolapse (POP).
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between pelvic floor morphological changes and age
Key secondary outcomes
1) Morphological characteristics of the pelvic floor musculature
2) Association between pelvic floor muscle structure and aging
3) Anatomical positional relationship between the pelvic floor and the pelvic bones
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Cases in which individuals underwent a health screening examination, and no pathological findings were detected
2. Cases in which pelvic CT or MRI was performed due to the presence of symptoms, but no pathological findings were detected
Key exclusion criteria
1. Cases in which patients were unable to maintain a stable position during CT or MRI examination, resulting in motion artifacts that precluded detailed image evaluation
2. Cases with pelvic masses or cystic lesions that may affect pelvic floor morphology
3. Cases with a history of pelvic surgery or trauma
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Itsuko |
| Middle name | |
| Last name | Okuda |
Organization
International University of Health and Welfare, Mita Hospital
Division name
Department of Diagnostic Radiology
Zip code
108-8329
Address
1-4-3 Mita, Minato-ku, Tokyo, Japan
TEL
03-3451-8121
okudai@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Itsuko |
| Middle name | |
| Last name | Okuda |
Organization
International University of Health and Welfare, Mita Hospital
Division name
Department of Diagnostic Radiology
Zip code
108-8329
Address
1-4-3 Mita, Minato-ku, Tokyo, Japan
TEL
0334518121
Homepage URL
https://www.iuhw.ac.jp/research/ethics/index.html
okudai@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare, Mita Hospital
Institute
Department
Personal name
Itsuko Okuda
Funding Source
Organization
Self-procurement
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
International University of Health and Welfare Mita Hospital Ethics Committee
Address
1-4-3 Mita, Minato-ku, Tokyo, Japan
Tel
03-3451-8121
otoiawase@iuhw.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
| 2025 | Year | 02 | Month | 12 | 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
300
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
| 2017 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 25 | 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
A retrospective study utilizing imaging data of CT and MRI
Management information
Registered date
| 2025 | Year | 02 | Month | 11 | Day |
Last modified on
| 2025 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065139
