- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04260646
Alarm Treatment for Combined Enuresis and Daytime Urinary Incontinence in Children (ABDE)
Enuresis Alarm for Treatment of Urinary Incontinence in Children With Combined Daytime Incontinence and Enuresis
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Aalborg, Denmark, 9000
- Dept pediatrics, Aalborg University Hospital
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Aarhus N, Denmark, 8200
- dept Pediatrics, Aarhus University Hospital
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Herning, Denmark, 7400
- Børneafdelingen, Herning
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Hjørring, Denmark, 9800
- Dept pediatrics, North Denmark Regional Hospital Hjoerring Hjoerring
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
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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
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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
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Number of wet nights pr week
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Will be calculated from registrations at baseline and week 8 of intervention
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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
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maximal voided volume from bladder diary in ml
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Will be calculated from 48h registrations at baseline and at week 8 of intervention
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Change in Daytime urinary incontinence episodes (DUI episodes)
Time Frame: Will be calculated from 48h registrations at baseline and at week 8 of intervention
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Daytime urinary incontinence episodes by bladder diary (episodes per day)
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Will be calculated from 48h registrations at baseline and at week 8 of intervention
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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
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fluid intake from bladder diary (ml fluid per day)
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Change in Fluid intake from 48h registrations at baseline and week 8 of intervention
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Change in enuresis time
Time Frame: Change in timepoint of enuresis from week1 to week8
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time of enuresis during night (timepoint)
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Change in timepoint of enuresis from week1 to week8
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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
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number of enuresis episodes (episodes per week)
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Change in number of weekly enuresis measured one week at Baseline (before intervention) and week 8 of intervention i alarm group
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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
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number of nocturia episodes/nights (nocturia episodes per night)
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Change in number of nocturiaepisodes per night measured one week at Baseline (before intervention) and week 8 of intervention
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Urologic Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urination Disorders
- Elimination Disorders
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Urinary Incontinence
- Enuresis
- Nocturnal Enuresis
Other Study ID Numbers
- N-20170005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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