Programmable Timer in the Bladder Rehabilitation Treatment of OAB

Urinary Incontinence Clinical Trial

Official title:

The Effect of Programmable Timer in Bladder Rehabilitation Treatment of Idiopathic Overactive Bladder in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00238680
• Other study ID #: SHTIMER2005
• Secondary ID: 2005-41-4853, 20
• Status: Completed
• Phase: N/A
• First received: October 12, 2005
• Last updated: June 13, 2008
• Start date: March 2005
• Est. completion date: April 2007

Study information

• Verified date: June 2008
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of bladder rehabilitation in a non-selected group of children with idiopathic overactive bladder and to clarify whether the effect of the treatment can be increased by addition of a programmable timer

Description:

Daytime urinary incontinence is common in children. At the age of 7 a prevalence of 2-9 % has been reported. Daytime urinary incontinence is a heterogenic multifactorial illness where the the symptoms has several degrees of severity and can be caused by different mechanisms. Daytime urinary incontinence can be etiologically classified in the rare neurogenic and structural forms and the common functional or idiopathic form (where no neurological or structural cause of the bladder dysfunction can be identified.

The symptom based diagnosis OAB (overactive bladder) is most often used to describe daytime urinary incontinence in children. OAB is defined as a symptom syndrome including urgency with or without urge incontinence in combination with frequency.

When urinary tract infection and neurogenic and structural causes has been excluded the nonpharmacological bladder rehabilitation is first line treatment in children with OAB. It is expected that approximately 50 % of the children can be relieved of symptoms by this treatment. The treatment consist of instruction in good micturition habits including toilet position, sufficient fluid intake and voidings at predefined intervals. The treatment effect is to a large degree dependent upon the ability of the children to void at fixed intervals. Children at the age of 5-10 yrs generally find this difficult and a programmable timer seems be an useful instrument in order to remind the child of voiding at fixed times. However there has not been published studies of the effect of programmable timer.

Hypothesis:

• Daytime urinary incontinence in children aged 5-15 with idiophatic OAB can in 50 % of cases be cured by bladder rehabilitation

• The compliance of the bladder rehabilitation treatment can for each individual be increased by adding a programmable timer to the treatment.

Material and methods:

100 children with idiopathic OAB will be recruited from the Center of Child Incontinence, Skejby University Hospital, Aarhus, Denmark.

After a run-in period of at least 4 weeks the children will be randomized to 12 weeks of bladder rehabilitation with or without programmable timer.

The effect of the treatment will be estimated based on home recordings.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2007
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 15 Years

Eligibility

Inclusion Criteria:

• Daytime urinary incontinence with at least 1 episode of at least 1 ml per week

• More than 6 voidings per day

• Informed consent

Exclusion Criteria:

• Known diseases of the kidneys or urinary tract besides OAB

• Receiving treatment with drugs that have an effect on the urine production or bladder function

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive
• Urinary Incontinence

Intervention

Behavioral:
• Bladder rehabilitation

• Bladder rehabilitation with programmable timer

Locations

Country	Name	City	State
Denmark	Department of pediatrics, University hospital of Aarhus, Skejby Sygehus	Aarhus	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical effects evaluated by home registrations of incontinence episodes and frequency volume charts at specified intervals.
Secondary	Bladder capacity measure before and after treatment.