Evaluation of the additional effect of continuous ultrasound bladder monitoring in urotherapy for children with functional daytime urinary incontinence. The SENS-U trial

Functional urinary incontinence is a common condition with a prevalence of
10-20% in 7 year-old children. It is associated with an impaired Qol, lower
self-esteem, and social stigmatization. Children rate *wetting their pants in
class* repeatedly in the top 5 of most stressful life events.

First line treatment according to the International Children*s Continence
Society (ICCS) is urotherapy. Urotherapy is a noninvasive, nonpharmacological
treatment, defined as bladder re-education or rehabilitation aiming at
correcting the filling and voiding function of the bladder-sphincter unit.
Urotherapy combines education and demystification of lower urinary tract
(dys)function, behavioral modification instructions, lifestyle advice regarding
fluid intake, voiding frequencies, registration of voided volumes and
incontinence episodes, and support/encouragement to children and their parents.
In urotherapy, tools like voiding diaries and wearable alarm systems are
commonly used. They are intended to gain insight in voiding behavior and to
teach children how to respond adequately to bladder filling and voiding
signals.

A new wearable bladder sensor recently became available, the SENS-U. This is a
small, wireless ultrasonic sensor, which continuously monitors bladder filling
and alarms the child when it is time to void. The SENS-U may increase
children*s awareness of the sensation of a full bladder. It can be personalized
by adjusting the percentage of bladder filling at which it sends an alarm,
based on the children*s own bladder capacity and voiding diary data. This
teaches children which bladder sensation corresponds to a nearly full bladder.
In current urotherapy, the bladder sensation that corresponds to a full bladder
can only be explained by the urotherapist. Biofeedback on bladder filling with
the SENS-U enables children to directly feel what the urotherapist means,
thereby inducing less trial-and-error. This reduces the number of failing
experiences. Furthermore, we expect steeper individual learning curves and more
cost-effective urotherapy.

To evaluate cost effectiviness of the SENS-U (continuous ultrasonic bladder
monitoring) in urotherapy for children with functional daytime urinary
incontinence.

Multicenter RCT comparing urotherapy alone, with SENS-U, and with sham device.
Children are randomized per center. There are four participating centers.

Urotherapy with the SENS-U. The SENS-U is a wearable ultrasound device that
continuously measures bladder filling and gives an alarm at a preset bladder
filling (e.g. 80% filling). The SENS-U provides biofeedback that teaches the
child at which feeling of the bladder (e.g. the feeling corresponding with 80%
filling) the child has to void.
The feeling of a device on the children*s belly could increase awareness of
their bladder and might induce a placebo effect. Therefore, we include a
placebo group, wearing a sham device that alerts independent of bladder filling
at a set interval. The SHAM device resembles the traditional timer watch which
is currently often used in urotherapy. Therefore it is not considered an extra
burden for children to wear a SHAM device. The SHAM and accompanying
instructions are identical to the SENS-U. The interval between alarms is
randomly chosen between 2 to 3 hours to appear realistic.

Urotherapy is care as usual which includes standard procedures like a voiding
diary, frequency voiding chart (FVC) and uroflowmetry and residual measurement
(PVR) and regular contact moments with the health care provider. This is not an
extra burden for subjects. To monitor incontinence-related QOL and adherence,
questionnaires are used at T0, T3 and T6. The SENS-U or SHAM are alarm devices
without additional risks which might give discomfort or redness of the skin
while wearing it. The SENS-U and sham device automatically register whether
they are worn or not to measure adherence. The amount of questionnaires is
limited and no intimate questions are asked.
All subjects might benefit from treatment with reduction in wetting accidents
after treatment. The extent of reduction in wetting accidents or time to
achieve response might be beneficial for those wearing an alarm device.