Alarm Treatment for Combined Enuresis and Daytime Urinary Incontinence in Children (ABDE)

  • STATUS
    Recruiting
  • days left to enroll
    57
  • participants needed
    90
  • sponsor
    Aalborg University Hospital
Updated on 29 May 2022
incontinence
nocturnal enuresis
bladder diary
enuresis
urinary incontinence in children

Summary

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.

Description

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:

  1. That the enuresis alarm therapy is beneficial in DUI treatment.
  2. That it is possible to treat enuresis before daytime continence has been achieved

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.

Details
Condition Incontinence, Urinary, Enuresis, Nocturnal, Enuresis
Treatment Enuresis Alarm Rodger and Timer watch (Rodger), Timer watch (Rodger)
Clinical Study IdentifierNCT04260646
SponsorAalborg University Hospital
Last Modified on29 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 5-14 years
Completed "Tørfisk" (Danish version of the Bower "Dry pie" Incontinence diary 1) and bladder diary (containing frequency and volume of voiding, fluid intake through 48 hours as well as 7 days night registering of nocturnal urine production (NUP) and wet nights.)
A minimum of 2 wet days per week
A minimum of 2 wet nights per week
Average NUP (aNUP) on wet nights of less than 130 % of expected bladder capacity (EBC=30(age+1))
Obtained oral and written informed consent from the participant and both custody holders

Exclusion Criteria

Known renal- or urinary tracts anomalies that affects the incontinence
Ongoing urinary tracts infection (UTI)
Ongoing obstipation defined by ROM IV criteria
Glycosuria or proteinuria
Previously received treatment with anticholinergics
Previously received treatment with enuresis alarm
Sign on neurological or structural cause of the incontinence
Reduced compliance for alarm treatment defined as use of the alarm less than 80 % of the nights of the treatment period
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