Working... Menu

Evaluation Study of Ultrasound Bladder Scanner for Monitoring Bladder Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
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.


  • 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.

Layout table for study information
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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

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 identifier (NCT number): NCT00277615

Layout table for location information
Department of pediatrics, University hospital of Aarhus, Skejby Sygehus
Aarhus, Aarhus N, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Layout table for investigator information
Principal Investigator: Soeren Hagstroem, MD University of Aarhus

Layout table for additonal information
Responsible Party: University of Aarhus 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:
Bladder volume