NIPH Clinical Trials Search

JRCT ID: jRCTs062210073

Registered date:31/01/2022

Accuracy study of bladder ultrasound equipment.

Basic Information

Recruitment status Pending
Health condition(s) or Problem(s) studiednone
Date of first enrollment31/01/2022
Target sample size6
Countries of recruitment
Study typeOther
Intervention(s)1.After injecting saline solution, measure the intravesical urine volume using "General-purpose echo (TOSHIBA Xario200, device name: TUS-X200)", "Lilliam One", "Lilliam IP200", and "Lilliam Spot 2" each time. Also, measure the time required to measure each modality.In addition to measuring, urine is collected each time to measure the amount of fluid in the bladder. 2.Saline injection volume After 400 mL, consider the subject's limit and inject repeatedly if possible. When the limit is reached, the amount of residual fluid in the bladder is excreted and the actual amount of excretion (accuracy is examined by measuring and recording the amount of urine drainage). The investigator decides whether to continue the measurement within the range of. Wipe off the leaked amount with gauze etc. and record the urine volume and use it as a reference value for analysis. The limit amount (maximum bladder volume urine volume) is based on the questionnaire survey of the subjects, but since the maximum bladder volume urine volume changes from time to time, it is up to the doctor to decide how much physiological saline can be injected at the time of implementation. Basically, the guideline is 70% or less of the limit amount obtained from the questionnaire. 3.As a general rule, the injection rate of physiological saline solution is 50 mL / min, but it is also possible to inject at 20-25 mL / min depending on the adjustment.


Primary OutcomeMeasurements of each of the four modality including general purpose echo for intravesical saline (1) Comparison between the measured value of intravesical urine volume by ultrasound and the volume of urinary catheterization (2) Time required for measurement (3) Reproducibility of each measuring device (4) Posture effect(Only Lilium-SPOT 2) (5) Impact of measurer(Only Lilium-SPOT 2)
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 39age old
Include criteria(1)Healthy male, aged from 20 to 39 (2)Those who are judged to be healthy with less than 100 mL of residual urine in the bladder based on the echo (general-purpose echo) measurement value of the ultrasonic diagnostic imaging device for the bladder performed after obtaining consent.
Exclude criteria(1)Subject with lower urinary tract disorder (2)Subject judged by a doctor to have a lot of residual urine by general-purpose echo (3)Subject determined to be ineligible by the principal investigator

Related Information


Public contact
Name Ryoji Sugiura
Address 2-16-10,Tanashi-cho,Nishitokyo-shi,Tokyo,Japan Tokyo Japan 188-0011
Telephone +81-90-3433-0055
Affiliation MAX INTEGRA JAPAN Co., Ltd.
Scientific contact
Name Yuzuri Sato
Address 37-26,Higashimachi 4-chome,Koganei-shi,Tokyo,Japan Tokyo Japan 184-0011
Telephone +81-42-382-3888
Affiliation Higashikoganei sakura clinic