Accuracy study of bladder ultrasound equipment.

JRCT ID: jRCTs062210073

Registered date:31/01/2022

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: none
• Date of first enrollment: 31/01/2022
• Target sample size: 6
• Study type: Other

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.

Outcome(s)

Primary Outcome

Measurements 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)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 39age old
• Gender: Male

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

• Primary Sponsor: Sato Yuzuri
• Source(s) of Monetary Support: Lilium Otsuka Co.,Ltd