In this study, the aim is to perform a home based evaluation of the SENS-UTM Bladder Sensor during the night to examine the usability of the SENS-UTM for ambulatory care in children with nocturnal enuresis.
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 total number of natural nocturnal bladder
filling cycles. This requires an increase in anterior-posterior bladder
dimension over the time of one filling cycle.
Secondary outcome
The second study parameter is the position transition factor to determine the
influence of sleep position on A-P bladder dimension. This transition factor is
defined as the A-P dimension of the old position divided by the bladder
dimension of the new position. The final study parameter is the theoretical
notification success-rate. Other parameters which are documented are: A-P
bladder dimensions (mm), voided volumes (mL), weight of diaper (mg), voiding
times (hh:mm), body position, contact adhesive and skin and spout of gel. In
addition, differential diagnosis, gender, age, length, weight, abdominal girth
(cm) of the 15 children will be documented.
Background summary
Nocturnal enuresis is a common problem in 7-year olds; 5-10% suffer from this
condition. Nocturnal enuresis is uncontrollable leakage of urine during the
night. When there are no bladder bowel dysfunction symptoms present together
with enuresis, it is called mono-symptomatic nocturnal enuresis. One of the
treatment options is alarm therapy. Currently, the wetting alarm is based on
negative reinforcement to teach pelvic floor contraction when urine leaks. The
SENS-U* Bladder Sensor is designed to help children stay dry during night and
day, by providing a notification before the maximum bladder capacity is
reached. Clinical results showed that the SENS-U* (formerly, NovioMini Bladder
Monitor) was able to detect a full bladder during urodynamic research with a
detection rate of at least 90%.
Study objective
In this study, the aim is to perform a home based evaluation of the SENS-UTM
Bladder Sensor during the night to examine the usability of the SENS-UTM for
ambulatory care in children with nocturnal enuresis.
Study design
This study is designed as an observational feasibility study, in which children
are measured during the night at home. The SENS-UTM will measure
anterior-posterior bladder dimension and sleep position. The SENS-UTM will be
positioned before bed-time by the researcher. During the night, urine volume is
collected in a measurement cup. The next morning, the SENS-UTM is removed by
the researcher. Before and after measurement, the children*s sleep habits sub
questionnaire is filled in.
Study burden and risks
There are no known risks associated with the use of the SENS-UTM. The burden is
relatively low for the patient. They are asked to fill in the children*s sleep
habit sub questionnaire before and after the measurement with their parents.
The parents are also asked to fill in the voiding diary during the night.
Henri Dunantstraat 1
Den Bosch 5223
NL
Henri Dunantstraat 1
Den Bosch 5223
NL
Listed location countries
Age
Inclusion criteria
- Monosymptomatic nocturnal enuresis
- age between 6 to 12 years (<12)
- permission of parents/guardians to let their child participate in the study
- capability of the child to understand the procedure
Exclusion criteria
- small bladder capacity : less than 65% of the expected bladder capacity
- breached skin, open wounds, sutures or major scar tissue in the suprabubic region
- nightly use of a (suprabubic) catheter
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 | NL66810.028.18 |