UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057131 |
|---|---|
| Receipt number | R000065304 |
| Scientific Title | Diagnostic Accuracy of Costovertebral Angle Tenderness and Bimanual Kidney Palpation for Urinary Tract Infection: A Prospective Observational Study |
| Date of disclosure of the study information | 2025/03/01 |
| Last modified on | 2025/08/27 10:59:46 |
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Basic information
Public title
Diagnostic Accuracy of Costovertebral Angle Tenderness and Bimanual Kidney Palpation for Urinary Tract Infection: A Prospective Observational Study
Acronym
Diagnostic Accuracy of Costovertebral Angle Tenderness and Bimanual Kidney Palpation for Urinary Tract Infection: A Prospective Observational Study
Scientific Title
Diagnostic Accuracy of Costovertebral Angle Tenderness and Bimanual Kidney Palpation for Urinary Tract Infection: A Prospective Observational Study
Scientific Title:Acronym
Diagnostic Accuracy of Costovertebral Angle Tenderness and Bimanual Kidney Palpation for Urinary Tract Infection: A Prospective Observational Study
Region
| Japan |
Condition
Condition
urinary tract infection
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the diagnostic performance of physical findings including costovertebral angle tenderness and kidney tenderness on bimanual palpation, in predicting urinary tract infections in febrile patients.
Basic objectives2
Others
Basic objectives -Others
Diagnostic performance
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Sensitivity and specificity of costovertebral angle tenderness and bimanual kidney palpation for renal tenderness in the diagnosis of urinary tract infection
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult febrile patients who visited the emergency department and were hospitalized
Key exclusion criteria
Patients with severe sensory impairment of the trunk (e.g., spinal cord injury) or known acquired renal anatomical abnormalities, such as a history of nephrectomy or renal transplantation.
Target sample size
1250
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Kano |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Department of Emergency and General Medicine
Zip code
1838524
Address
2-8-29 Musashidai, Fuchu, Tokyo 183-8524, Japan
TEL
(+81)42-323-5111
yasuhiro.kano.21@gmail.com
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Kano |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Department of Emergency and General Medicine
Zip code
1838524
Address
2-8-29 Musashidai, Fuchu, Tokyo 183-8524, Japan
TEL
(+81)42-323-5111
Homepage URL
yasuhiro.kano.21@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Tama Medical Center
Institute
Department
Personal name
Yasuhiro Kano
Funding Source
Organization
None
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
Tokyo Metropolitan Tama Medical Center
Address
2-8-29 Musashidai, Fuchu, Tokyo 183-8524, Japan
Tel
(+81)42-323-5111
yasuhiro.kano.21@gmail.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
| 2025 | Year | 03 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | 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
Review of medical records
Management information
Registered date
| 2025 | Year | 02 | Month | 25 | Day |
Last modified on
| 2025 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065304
