UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057224 |
|---|---|
| Receipt number | R000062040 |
| Scientific Title | Investigation of the usefulness of an electronic urine volume analyzer (Urodialysis Checker) |
| Date of disclosure of the study information | 2025/03/06 |
| Last modified on | 2026/03/07 12:40:39 |
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Basic information
Public title
Investigation of the usefulness of an electronic urine volume analyzer (Urodialysis Checker)
Acronym
Investigation of the usefulness of an electronic urine volume analyzer (Urodialysis Checker)
Scientific Title
Investigation of the usefulness of an electronic urine volume analyzer (Urodialysis Checker)
Scientific Title:Acronym
Investigation of the usefulness of an electronic urine volume analyzer (Urodialysis Checker)
Region
| Japan |
Condition
Condition
Patients attending the hospital with main complaints of lower urinary tract symptoms such as benign prostatic hyperplasia (BPH) and overactive bladder
Classification by specialty
| Urology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the effectiveness and safety of the Urodialysis Checker compared to conventional methods.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the use of the Urodiary Checker, an electronic urine output measuring device, compared to the conventional urinary logbook method.
Key secondary outcomes
Assessment of background factors.such as IPSS, IPSS, IPSS-QOL, Sleep Questionnaire, G8
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Allow a period of time for the patient to use the Urodiary Checker and a period of time for the patient to record frequency volume charts.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Age: Any age
(2) Gender: No preference
(iii) Place of residence: A place where you can go to our hospital or affiliated hospitals.
(4) Able to urinate by oneself
(5) Able to answer various questions
(6) Patients who have received a thorough explanation of their participation in this study and have given written consent of their own free will or that of their family members.
Key exclusion criteria
Patients deemed inappropriate as research subjects by the principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Terada |
Organization
University of Fukui
Division name
Urology
Zip code
9101193
Address
23-3, Matsuoka Shimoaizuki, Eiheiji cho, Yoshida gun
TEL
0776613111
urokumura@gmail.com
Public contact
Name of contact person
| 1st name | Yoshinaga |
| Middle name | |
| Last name | Okumura |
Organization
University of Fukui
Division name
urology
Zip code
9101193
Address
23-3, Matsuoka Shimoaizuki, Eiheiji cho
TEL
0776613111
Homepage URL
urokumura@gmail.com
Sponsor or person
Institute
Universty of FUkui
Institute
Department
Personal name
Funding Source
Organization
self funding
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
The Research Ethics Committee of University of Fukui
Address
23-3, Matsuoka Shimoaizuki, Eiheiji cho, Yoshida gun
Tel
0776613111
chiken@ml.u-fukui.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 | 03 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 02 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 13 | 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
| 2025 | Year | 03 | Month | 06 | Day |
Last modified on
| 2026 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062040
