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Evaluation Study of Ultrasound Bladder Scanner for Monitoring Bladder Function

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ClinicalTrials.gov Identifier: NCT00277615
Recruitment Status : Unknown
Verified January 2012 by University of Aarhus.
Recruitment status was:  Active, not recruiting
First Posted : January 16, 2006
Last Update Posted : January 23, 2012
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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

Condition or disease
Dysfunction of the Urinary Bladder

Detailed 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.


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Study Type : Observational
Estimated Enrollment : 30 participants
Time Perspective: Prospective
Official Title: Clinical Evaluation of a Portable Ultrasound Bladder Scanner for Continuous Monitoring of Bladder Function in Children.
Study Start Date : October 2005
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound





Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children with OAB
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00277615


Locations
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Denmark
Department of pediatrics, University hospital of Aarhus, Skejby Sygehus
Aarhus, Aarhus N, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Soeren Hagstroem, MD University of Aarhus

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00277615     History of Changes
Other Study ID Numbers: SHUL2006
2005-41-5570, 20050083
First Posted: January 16, 2006    Key Record Dates
Last Update Posted: January 23, 2012
Last Verified: January 2012

Keywords provided by University of Aarhus:
Children
Bladder volume
Ultrasound