This trial is active, not recruiting.

Condition dysfunction of the urinary bladder
Sponsor University of Aarhus
Start date October 2005
End date December 2012
Trial size 30 participants
Trial identifier NCT00277615, 2005-41-5570, 20050083, SHUL2006


The purpose of this study is to evaluate a novel ultrasound bladder scanning device designed particularly for children in children with bladder dysfunction.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Time perspective prospective

Eligibility Criteria

Male or female participants from 4 years up to 15 years old.

Inclusion Criteria: - Age between 4-16 yrs - Dependent on bladder emptying by catheterization - Informed consent Exclusion Criteria: - Wounds, scar tissue or staples in the suprapubic area - Severe urinary incontinence

Additional Information

Official title Clinical Evaluation of a Portable Ultrasound Bladder Scanner for Continuous Monitoring of Bladder Function in Children.
Principal investigator Soeren Hagstroem, MD
Description A continuous precise monitoring of bladder volume is of great impotence in many nephro-urological diseases in children. Some children suffer from bladder dysfunctions that necessitate bladder emptying by catheterization. The bladder catheterizations are at present performed at fixed time intervals and are not based on the amount of urine in the bladder. In order to avoid overfilling of the bladder, the interval between the emptying is set with a safety margin. This leads to at least some needless catheterizations and hereby discomfort for the children. A portable bladder monitor could possible give a measurement of the degreed of bladder filling and hereby minimize the number of catheterizations needed. Another group of children suffers from daytime urinary incontinence as a result of overactive bladder syndrome. Home recordings of fluid intake and micturations are used for diagnosing the cause of the decease however; a portable bladder monitor system would possibly give a more true reflection of the bladder function. With a prevalence of about 10 % nocturnal enuresis is the most common nephro-urological disorder of childhood. In this group of children a portable bladder monitor may enable a more precise measure of bladder function. In addition to this the monitor may be used as a alarm device in the treatment of the disorder. The portable ultrasound bladder scanner tested has been designed particularly for children. Hypothesis: - The bladder volume estimated by the portable ultrasound bladder scanner is concordant with "true" bladder volume measured by catheterization in children. - The portable ultrasound bladder scanner can be used for continuous non-invasive monitoring of bladder volume during natural fill in children with bladder dysfunction. 30 children that suffer from bladder dysfunction and perform bladder emptying by catheterization will be recruited from the Center of Child Incontinence, Skejby University Hospital, Aarhus, Denmark.
Trial information was received from ClinicalTrials.gov and was last updated in January 2012.
Information provided to ClinicalTrials.gov by University of Aarhus.