In this study, the aim is to perform a clinical evaluation of the NovioMini in children during behavioural bladder training to examine the performance of the NovioMini as a full-bladder-based notification system during natural bladder filling.
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 of this study is the full bladder notification
success-rate. The notification success-rate is stated as the number of times
the NovioMini notified the child of a full bladder prior to micturition,
divided by the micturition frequency (number of times the child voided while
wearing the NovioMini).
Secondary outcome
The second study parameter of this study is the level of compliance of the
patient to respond to the NovioMini notification(s). The level of compliance is
stated as the number of times the patient alerts the urotherapist/researcher of
the notification, divided by the number of times the NovioMini notified the
child of a full bladder prior to micturition.
The final study parameters are (for each patient): micturition frequency,
number of wet incidents (wet vs. dry), the bladder volumes and if urge symptoms
occur, while wearing the NovioMini.
Finally, the (differential) diagnoses, gender, age, length, weight, BMI, the
time of voiding, time the NovioMini goes off, total wear time of the NovioMini
will be documented for the children in the study. Based on these parameters, a
description of the study population will be made.
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 behavioural bladder training to examine the performance of the
NovioMini as a full-bladder-based notification system during natural bladder
filling.
Study design
The study is designed as an observational, feasibility study in which children
who are scheduled for a behavioural bladder training are included. Parallel to
the standardized clinical protocol, the NovioMini Bladder Monitor will
continuously measure the anterior * posterior bladder dimensions to determine
when the bladder is full. When the NovioMini states that the filling status
exceeds the pre-established full bladder threshold, the patient will be
informed by a vibration signal of the device and a notification on the
smartphone. When this occurs, the patient informs the urotherapist or
researcher, same as for the wetting alarm which is used during the training. At
the end of the day, the NovioMini will be removed and a couple of questions
will be asked to determine the experiences of the patient with the device.
Study burden and risks
The patients who are included in this observational study are already scheduled
for a bladder training. During the training, 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 when the bladder is full. At the end of the training day, 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 who are scheduled for an inpatient bladder training
* Children between the ages of 6 to 16 years.
* Children are capable of understanding the procedure.
* Parents / Guardians agree to let their child participate in the study.
Exclusion criteria
* Patients with breached skin, open wounds, sutures or major scar tissue in the suprapubic region.
* Patients with a suprapubic catheter (which prevents positioning the NovioMini properly)
* Patients with severe obesity (BMI > 95th percentile, according to age/gender)
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 | NL62895.041.17 |