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Completed

NCT Number: NCT04260646

Alarm Treatment for Combined Enuresis and Daytime Urinary Incontinence in Children

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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Key information

About this study

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:

  • That the enuresis alarm therapy is beneficial in DUI treatment.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enuresis Alarm Rodger and Timer watch (Rodger)

Device

Nocturnal enuresis fluid sensitive alarm and Timer watch (Rodger) vibrating or sounding alarm for remembering timed voiding intervals

Timer watch (Rodger)

Device

Timer watch (Rodger) vibrating or sounding alarm for remembering timed voiding intervals

Primary outcomes

  1. Change in Daytime incontinence-score

    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

  2. Change in Relative number of wet nights

    Time frame: Will be calculated from registrations at baseline and week 8 of intervention

    Number of wet nights pr week

Secondary outcomes

  1. Change in MVV (maximal voided volume)

    Time frame: Will be calculated from 48h registrations at baseline and at week 8 of intervention

    maximal voided volume from bladder diary in ml

  2. Change in Daytime urinary incontinence episodes (DUI episodes)

    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)

Other outcomes

  1. Change in fluid intake

    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)

  2. Change in enuresis time

    Time frame: Change in timepoint of enuresis from week1 to week8

    time of enuresis during night (timepoint)

  3. Change in number of enuresis episodes

    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)

  4. change in Nocturia frequency

    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)

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Collaborators

  • Aarhus University Hospital
  • Regional Hospital West Jutland
  • Regionshospital Nordjylland

Registry information

Official study title

Enuresis Alarm for Treatment of Urinary Incontinence in Children With Combined Daytime Incontinence and Enuresis

Acronym: ABDE

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Feb 7, 2020
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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