UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060256 |
|---|---|
| Receipt number | R000068773 |
| Scientific Title | Accuracy validation of bladder ultrasound devices in individuals with high body mass index |
| Date of disclosure of the study information | 2026/01/05 |
| Last modified on | 2026/01/05 13:21:49 |
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Basic information
Public title
A study evaluating the measurement accuracy of bladder ultrasound devices in individuals with high BMI
Acronym
BMI-BLADDER Study
Scientific Title
Accuracy validation of bladder ultrasound devices in individuals with high body mass index
Scientific Title:Acronym
BMI-Bladder Accuracy Study
Region
| Japan |
Condition
Condition
Healthy adults with high body mass index
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the accuracy of bladder volume measurements obtained using a portable ultrasound device in individuals with high BMI, in comparison with an established ultrasound-based reference method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Difference in measured bladder volume between the portable bladder ultrasound device and the reference ultrasound method
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Measurement of bladder volume using a portable bladder ultrasound device and a portable/tablet type general ultrasound device
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
University sumo club members aged 18 years or older
Body mass index more than 30
Provided written informed consent
Key exclusion criteria
Participants who expressed refusal to participate in this study.
Participants who were judged by a physician to have hypertension, diabetes mellitus, heart disease, or other medical conditions requiring treatment.
Participants in whom serious health problems were identified prior to the start of the study.
Target sample size
37
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Takahashi |
Organization
Nihon University Itabashi Hospital (Tokyo, Japan)
Division name
Department of Urology
Zip code
173-8610
Address
30-1 Oyaguchikamicho, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
takahashi.satoru@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Takahashi |
Organization
Nihon University Itabashi Hospital (Tokyo, Japan)
Division name
Department of Urology
Zip code
173-8610
Address
30-1 Oyaguchikamicho, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
Homepage URL
takahashi.satoru@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Indutry
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Itabashi Hospital Clinical Research Ethics Committee
Address
30-1 Oyaguchikamicho, Itabashi-ku, Tokyo 173-8610, Japan
Tel
03-3972-8111
cri@med.nihon-u.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
| 2026 | Year | 01 | Month | 05 | 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
40
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
| 2025 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 21 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 27 | Day |
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 05 | Day |
Last modified on
| 2026 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068773
