In this study, the aim is to perform a clinical evaluation of the NovioMini in children during (video) urodynamics to examine the performance of the NovioMini over a wider range of bladder volumes and to determine if these is a relation between the…
ID
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the full bladder detection rate of the NovioMini in
children during (video) urodynamics. The full bladder detection is defined as
the number of times a full bladder is detected by the NovioMini, divided by the
number of bladder fillings during (V)UDO.
Secondary outcome
The second study parameter is the Pearson*s correlation coefficient r to
determine if there is a linear correlation between the infused bladder volume
during urodynamics and the measured anterior * posterior bladder dimension
determined by the NovioMini Bladder Sensor. The final study parameters of this
study are the maximum urinary bladder dimensions, maximum infused bladder
volume, voided volume and residual volume (after voiding) for each child and
for the range of these parameters for the entire study population of 30
children. Also, the time the child feels the urge to void is documented.
Finally, the following baseline characteristics will be collected: the
(differential) diagnoses of urinary incontinence, gender, age, length, and
weight and postural position (during (video)urodynamics) of the 30 children.
Background summary
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. Urinary incontinence 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 NovioMini Bladder Monitor is
developed. The NovioMini is an ultrasound sensor which is capable of measuring
changes in the anterior * and posterior bladder over time. 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.
Study objective
In this study, the aim is to perform a clinical evaluation of the NovioMini in
children during (video) urodynamics to examine the performance of the NovioMini
over a wider range of bladder volumes and to determine if these is a relation
between the anterior * posterior bladder dimension measured by the NovioMini
and the infused bladder volume.
Study design
The study is designed as an observational, feasibility study in which children
who are scheduled for a (video) urodynamic study are included. Parallel to the
standardized clinical protocol of the (video) urodynamic study, the NovioMini
Bladder Monitor will measure the anterior * posterior bladder dimensions every
30 sec to determine if there is a relation between this parameter and the
infused bladder volume. The NovioMini will be positioned before the start of
the filling phase and removed after the second voiding phase.
Study burden and risks
The patients who are included in this observational study are already scheduled
for a (video) urodynamic study. During the (video) urodynamic study, the
NovioMini Bladder Monitor is added as a minor supplement to the standardized
clinical protocol. During the study, the NovioMini is positioned on the lower
abdomen of the child and it will determine the urinary bladder dimension every
30 sec during the filling * and voiding phases. After the second voiding phase,
the NovioMini is removed. 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.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
- Children with urinary incontinence who are schedulded for (video) urodynamics
- Children between the ages of 6 to 12 years.
- Parents/ Guardians agree to let their child participate in the study.
- Children are capable of understanding the procedure.
Exclusion criteria
- Patients with breached skin, open wounds, sutures or major scar tissue in the suprapubic region.
- Patients with a suprapubic catheter.
- Patients with an urinary tract infection.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL59567.041.17 |