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

Urinary incontinence is defined as the involuntary or uncontrollable leakage of
urine and is a common problem in children and adults. In the Netherlands,
daytime incontinence for children older than four years is equals to 6-9% in
girls and 7% in boys. Dysfunctional voiding is a subtype of the daytime voiding
abnormalities, in which case the child habitually contracts the urethral
sphincter during voiding. The child develops a wrong type of behaviour in which
case they loss their urgency to go to the bathroom. They do not develop or even
lose the ability to consciously recognize a full bladder, which will result in
the involuntary leakage of urine when the bladder volume reaches its maximum.
Dysfunctional voiding has a major impact on the lives of both the child and the
family and it can result in a decrease in self-esteem, social isolation and
teasing. As a result of the negative impact of urinary incontinence on the
child*s quality of life, it is important that these children receive clinical
help and behavioural training. To increase the effectiveness of current
clinical treatments, the URIKA device is developed. The URIKA device is an
ultrasound sensor which is capable of measuring the distance between the
anterior - and posterior wall of the bladder. It can measure the filling status
of the bladder and can inform the patient when the bladder reaches its maximum
capacity and to prevent the child from wetting itself.

To determine the accuracy of the URIKA urinary bladder sensor in measuring the
distance between the anterior - and posterior wall of the bladder and to
determine the range in bladder diameters at which the child should be alarmed
to void.

Pilot study in 30 children with Dysfunctional Voiding.

The patient with dysfunctional voiding is subjected to an ultrasound monitoring
session of 1.5 - 2 hours during a full cycle of urinary bladder filling. During
this session, the URIKA device will determine the urinary bladder diameter
during filling. As a reference, also multiple two-dimensional ultrasound images
(Philips Medical Systems) will be made. The cycle of bladder filling is
monitored four times (divided over one or several days). There are no known
risks associated with ultrasound monitoring or imaging when the ultrasound
intensity is limited according to the current Food and Drug Administration
regulations. The burden is relatively low for the patient.