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Sponsored by: |
University of Aarhus |
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Information provided by: | University of Aarhus |
ClinicalTrials.gov Identifier: | NCT00238680 |
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
Condition | Intervention |
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Overactive Bladder Urinary Incontinence |
Behavioral: Bladder rehabilitation Behavioral: Bladder rehabilitation with programmable timer |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | The Effect of Programmable Timer in Bladder Rehabilitation Treatment of Idiopathic Overactive Bladder in Children |
Estimated Enrollment: | 100 |
Study Start Date: | March 2005 |
Study Completion Date: | April 2007 |
Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
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:
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.
Ages Eligible for Study: | 5 Years to 15 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Denmark, Aarhus N | |
Department of pediatrics, University hospital of Aarhus, Skejby Sygehus | |
Aarhus, Aarhus N, Denmark, 8200 |
Principal Investigator: | Soeren Hagstroem, MD | University of Aarhus |
Study ID Numbers: | SHTIMER2005, 2005-41-4853, 20040192 |
Study First Received: | October 12, 2005 |
Last Updated: | June 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00238680 History of Changes |
Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics; Denmark: Danish Dataprotection Agency |
Overactive bladder Children Bladder rehabilitation |
Signs and Symptoms Urinary Bladder, Overactive Cystocele Urologic Diseases |
Urination Disorders Urinary Bladder Diseases Urinary Incontinence |
Signs and Symptoms Urological Manifestations Urinary Bladder, Overactive Urologic Diseases |
Urination Disorders Urinary Bladder Diseases Urinary Incontinence |