RIKA, continuous ultrasound monitoring of urinary bladder filling in children with dysfunctional voiding: a pilot study.
Completed
- Conditions
- Dysfunctional Voiding10004994
- Registration Number
- NL-OMON44015
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
- Children with urinary incontinence, e.g. dysfunctional voiding.
- Children between the age of 6 and 12 years.
- Parents / Guardians agree to let their child participate in the study.
- Children are capable of understanding the procedure.
Exclusion Criteria
- Subjects with symptoms of constipation.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameter: measured distance (cm) between the anterior - and<br /><br>posterior wall of the urinary bladder, calculated by the software algorithm. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary study endpoint of the study is the range in maximum urinary<br /><br>bladder diameters per individual and in the entire study population of 30<br /><br>children with dysfunctional voiding. Furthermore, the Pearsons product - moment<br /><br>correlation coefficient will be estimated to determine the precision of the<br /><br>URIKA sensor, compared to traditional 2D ultrasound, for each angle. Also the<br /><br>age, gender, length and weight of the patients will be registered to establish<br /><br>a description of the study population.</p><br>