Programmable Timer in the Bladder Rehabilitation Treatment of OAB
Primary Purpose
Overactive Bladder, Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Bladder rehabilitation
Bladder rehabilitation with programmable timer
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive bladder, Children, Bladder rehabilitation
Eligibility Criteria
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
Sites / Locations
- Department of pediatrics, University hospital of Aarhus, Skejby Sygehus
Outcomes
Primary Outcome Measures
Clinical effects evaluated by home registrations of incontinence episodes and frequency volume charts at specified intervals.
Secondary Outcome Measures
Bladder capacity measure before and after treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00238680
Brief Title
Programmable Timer in the Bladder Rehabilitation Treatment of OAB
Official Title
The Effect of Programmable Timer in Bladder Rehabilitation Treatment of Idiopathic Overactive Bladder in Children
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Aarhus
4. Oversight
5. Study Description
Brief 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
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Urinary Incontinence
Keywords
Overactive bladder, Children, Bladder rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Bladder rehabilitation
Intervention Type
Behavioral
Intervention Name(s)
Bladder rehabilitation with programmable timer
Primary Outcome Measure Information:
Title
Clinical effects evaluated by home registrations of incontinence episodes and frequency volume charts at specified intervals.
Secondary Outcome Measure Information:
Title
Bladder capacity measure before and after treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soeren Hagstroem, MD
Organizational Affiliation
University of Aarhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of pediatrics, University hospital of Aarhus, Skejby Sygehus
City
Aarhus
State/Province
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
12. IPD Sharing Statement
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Programmable Timer in the Bladder Rehabilitation Treatment of OAB
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