urinary incontinence
Conditions
Interventions
(Video) Urodynamics
Bladder
Monitoring
Ultrasound Sensor
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
The Netherlands
Outcome results
None listed