URIKA, continuous ultrasound monitoring of urinary bladder filling in children with dysfunctional voiding: a pilot study.

URIKA, continuous ultrasound monitoring of urinary bladder filling in children with dysfunctional voiding: a pilot study. - URIKA sensor: Continuous monitoring of urinary bladder filling.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44015

Enrollment

Registered

2015-02-25

Start date

2015-04-16

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysfunctional Voiding

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: - Children with urinary incontinence, e.g. dysfunctional voiding. - Children between the age of 6 and 12 years. - Parents / Guardians agree to let their child participate in the study. - Children are capable of understanding the procedure.

Exclusion criteria

Exclusion criteria: - Subjects with symptoms of constipation.

Design outcomes

Primary

Measure	Time frame
Main study parameter: measured distance (cm) between the anterior - and posterior wall of the urinary bladder, calculated by the software algorithm.	—

Secondary

Measure	Time frame
The secondary study endpoint of the study is the range in maximum urinary bladder diameters per individual and in the entire study population of 30 children with dysfunctional voiding. Furthermore, the Pearsons product - moment correlation coefficient will be estimated to determine the precision of the URIKA sensor, compared to traditional 2D ultrasound, for each angle. Also the age, gender, length and weight of the patients will be registered to establish a description of the study population.	—

Measure

Time frame

The secondary study endpoint of the study is the range in maximum urinary bladder diameters per individual and in the entire study population of 30 children with dysfunctional voiding. Furthermore, the Pearsons product - moment correlation coefficient will be estimated to determine the precision of the URIKA sensor, compared to traditional 2D ultrasound, for each angle. Also the age, gender, length and weight of the patients will be registered to establish a description of the study population.

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Countries

Netherlands

Outcome results