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

March 8, 2024 updated by: Søren Hagstrøm, MD PhD, Aalborg University Hospital

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

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.

Study Overview

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Aalborg, Denmark, 9000
        • Dept pediatrics, Aalborg University Hospital
      • Aarhus N, Denmark, 8200
        • dept Pediatrics, Aarhus University Hospital
      • Herning, Denmark, 7400
        • Børneafdelingen, Herning
      • Hjørring, Denmark, 9800
        • Dept pediatrics, North Denmark Regional Hospital Hjoerring Hjoerring

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 14 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Urotherapy without enuresis alarm
Standard urotherapy inclunding normalized fluid intake and times voidings. The timed voiding regime of every 2 hours will be assisted by a timer Watch.
Timer watch (Rodger) vibrating or sounding alarm for remembering timed voiding intervals
Experimental: Standard Urotherapy with enuresis alarm
Standard urotherapy inclunding normalized fluid intake and times voidings. The timed voiding regime of every 2 hours will be assisted by a timer Watch. In addition an enuresis alarm will be provided and worn by the participants during the night.
Timer watch (Rodger) vibrating or sounding alarm for remembering timed voiding intervals
Nocturnal enuresis fluid sensitive alarm and Timer watch (Rodger) vibrating or sounding alarm for remembering timed voiding intervals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Score will be calculated pre intervention, at week 2, 4, 6, and 8 of intervention
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
Will be calculated from registrations at baseline and week 8 of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Will be calculated from 48h registrations at baseline and at week 8 of intervention
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)
Will be calculated from 48h registrations at baseline and at week 8 of intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change in Fluid intake from 48h registrations at baseline and week 8 of intervention
Change in enuresis time
Time Frame: Change in timepoint of enuresis from week1 to week8
time of enuresis during night (timepoint)
Change in timepoint of enuresis from week1 to week8
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)
Change in number of weekly enuresis measured one week at Baseline (before intervention) and week 8 of intervention i alarm group
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)
Change in number of nocturiaepisodes per night measured one week at Baseline (before intervention) and week 8 of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

February 28, 2023

Study Registration Dates

First Submitted

July 18, 2019

First Submitted That Met QC Criteria

February 6, 2020

First Posted (Actual)

February 7, 2020

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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