UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059515 |
|---|---|
| Receipt number | R000067244 |
| Scientific Title | Clinical trial of a new urinary flow measurement system using urination sounds |
| Date of disclosure of the study information | 2025/10/25 |
| Last modified on | 2025/10/23 14:26:56 |
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Basic information
Public title
Clinical trial of a new urinary flow measurement system using urination sounds
Acronym
Clinical trial of urination sound uroflowmetry
Scientific Title
Clinical trial of a new urinary flow measurement system using urination sounds
Scientific Title:Acronym
Clinical trial of urination sound uroflowmetry
Region
| Japan |
Condition
Condition
Lower urinary tract symptoms
Classification by specialty
| Urology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the clinical usefulness of a system that estimates urine flow measurement results from urination sounds.
Basic objectives2
Others
Basic objectives -Others
Verification of the equivalence of clinical test results
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum urine flow rate (Qmax), Average urine flow rate (Qave), Urine volume (V)
Key secondary outcomes
Visual comparison of urine flow curves
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Uroloflowmetry
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
<Healthy Volunteers>
1. Individuals without urinary disorders (International Prostate Symptom Score [IPSS] total of less than 8 points, Overactive Bladder Symptpm Score [OABSS] total of less than 3 points)
2. Individuals who can provide written consent for participation in the study willingly
3. Individuals aged 18 years or older
4. Gender: Male and Female
<Lower Urinary Tract Symptom (LUTS) Patients>
1. Patients with LUTS (IPSS total of 8 points or more, OABSS total of 3 points or more
2. Patients who can provide written consent for research participation voluntarily
3. Patients aged 18 years or older at the time of consent
4. Gender: Male and female
Key exclusion criteria
If the urine volume is less than 20 mL. If the urine flow test could not be completed.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Takeshita |
Organization
International University of Health and Welfare Hospital
Division name
Department of Urology
Zip code
329-2763
Address
537-3, Iguchi, Nasushiobara, Tochigi
TEL
+81-287-39-3060
takeshita-hideki-to@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Takeshita |
Organization
International University of Health and Welfare Hospital
Division name
Department of Urology
Zip code
329-2763
Address
537-3, Iguchi, Nasushiobara, Tochigi
TEL
+81-287-39-3060
Homepage URL
takeshita-hideki-to@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Hideki Takeshita
Funding Source
Organization
International University of Health and Welfare
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Saitama University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tochigi District Ethics Review Committee, International University of Health and Welfare
Address
537-3, Iguchi, Nasushiobara, Tochigi
Tel
+81-287-39-3060
s-rinri@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
国際医療福祉大学病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2028 | 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 | 10 | Month | 23 | Day |
Last modified on
| 2025 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067244
