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Status unknownNCT00277615Updated Jan 23, 2012

Evaluation Study of Ultrasound Bladder Scanner for Monitoring Bladder Function

An observational study in Dysfunction of the Urinary Bladder, sponsored by University of Aarhus. Status unknown at 1 site in Denmark. Open to participants aged 4 Years to 15 Years. Per ClinicalTrials.gov, last updated 2012-01-23.

Sponsored by University of Aarhus · Observational

The sponsor has not verified this record recently (last verified Jan 2012), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Time perspective
Prospective
Enrollment
30
Ages
4 Years to 15 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Dysfunction of the Urinary Bladder

Keywords

  • Children
  • Bladder volume
  • Ultrasound
03

In context

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 15 Years
Sexes eligible
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

Exclusion Criteria:

  • Wounds, scar tissue or staples in the suprapubic area
  • Severe urinary incontinence
05

Study design

Time perspective
Prospective
Enrollment
30 participants (estimated)
06

Study locations

1 site
  • Department of pediatrics, University hospital of Aarhus, Skejby Sygehus
    Aarhus, Aarhus N 8200, Denmark
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00277615
Lead sponsor
University of Aarhus
Responsible party
Sponsor
First posted
Jan 16, 2006
Start date
Oct 2005
Completion
Dec 2012 (estimated)
Last update
Jan 23, 2012

Study contacts

Soeren Hagstroem, MD
principal investigator · University of Aarhus

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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