Enuresis Alarm Rodger and Timer watch (Rodger)
DeviceNocturnal enuresis fluid sensitive alarm and Timer watch (Rodger) vibrating or sounding alarm for remembering timed voiding intervals
NCT Number: NCT04260646
The aim is to examine whether alarm therapy in addition to urotherapy can have a beneficial effect in treating urinary incontinence children with combined daytime incontinence and enuresis. The study will include children who suffers for combined daytime incontinence and enuresis and referred to one of the pediatric departments were offed to participate. Participants are randomized to 8 weeks treatment with either enuresis alarm and timer watch assist urotherapy or solely timer watch assisted urotherapy.
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Notify Me5 year–14 year
All sexes
Interventional
Not applicable
Dept pediatrics, Aalborg University Hospital, Aalborg, Denmark
Urinary incontinence are common disorders of school age children. Approximately 3.8 - 16.9 % of first grade children suffer from daytime incontinence (DUI) depending on the definitions. Half of the children with DUI suffers for enuresis (NE) too. The background for combined DUI and enuresis is in most children functional overactive bladder (OAB).
At present DUI is treated first with urotherapi, if insufficient bladder modulating drugs are added. When daytime continence is achieved, the enuresis is handled using (in cases of small bladder capacity) an enuresis alarm.
Whether daytime continence is a prerequisite for treating NE or whether enuresis alarm may positively influence DUI treatment has not been studies in a RCT previously.
The aim of this study is to examine whether alarm therapy in addition to urotherapy can have a beneficial effect in treating children with combined daytime incontinence and enuresis. Thus the hypothesis are:
Methods: The study is a randomized controlled trial. The participants will be approx. 90 children that suffers from combined enuresis and daytime urinary incontinence. The participants will be equally randomized to 8 week of timer watch assisted urotherapy 1) with or 2) without addition of enuresis alarm treatment. The study includes 3 outpatient visits and 2 phone contacts.
The participants will complete bladder diaries as well as drypie and nocturnal urine production registrations. Also registrations on number and time of enuresis will be recorded for the alarm group children. All children will be provided a timer watch.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Nocturnal enuresis fluid sensitive alarm and Timer watch (Rodger) vibrating or sounding alarm for remembering timed voiding intervals
Timer watch (Rodger) vibrating or sounding alarm for remembering timed voiding intervals
Time frame: Score will be calculated pre intervention, at week 2, 4, 6, and 8 of intervention
Incontinence-score calculated from Drypie scale between 0-21
Time frame: Will be calculated from registrations at baseline and week 8 of intervention
Number of wet nights pr week
Time frame: Will be calculated from 48h registrations at baseline and at week 8 of intervention
maximal voided volume from bladder diary in ml
Time frame: Will be calculated from 48h registrations at baseline and at week 8 of intervention
Daytime urinary incontinence episodes by bladder diary (episodes per day)
Time frame: Change in Fluid intake from 48h registrations at baseline and week 8 of intervention
fluid intake from bladder diary (ml fluid per day)
Time frame: Change in timepoint of enuresis from week1 to week8
time of enuresis during night (timepoint)
Time frame: Change in number of weekly enuresis measured one week at Baseline (before intervention) and week 8 of intervention i alarm group
number of enuresis episodes (episodes per week)
Time frame: Change in number of nocturiaepisodes per night measured one week at Baseline (before intervention) and week 8 of intervention
number of nocturia episodes/nights (nocturia episodes per night)
Aalborg University Hospital
Other
Enuresis Alarm for Treatment of Urinary Incontinence in Children With Combined Daytime Incontinence and Enuresis
Acronym: ABDE
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