Alarm Treatment for Combined Enuresis and Daytime Urinary Incontinence in Children (ABDE)
Primary Purpose
Incontinence, Urinary, Enuresis, Nocturnal, Enuresis
Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Enuresis Alarm Rodger and Timer watch (Rodger)
Timer watch (Rodger)
Sponsored by
About this trial
This is an interventional treatment trial for Incontinence, Urinary
Eligibility Criteria
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.
Sites / Locations
- Dept pediatrics, Aalborg University Hospital
- dept Pediatrics, Aarhus University Hospital
- Børneafdelingen, Herning
- Dept pediatrics, North Denmark Regional Hospital Hjoerring Hjoerring
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Urotherapy without enuresis alarm
Standard Urotherapy with enuresis alarm
Arm Description
Standard urotherapy inclunding normalized fluid intake and times voidings. The timed voiding regime of every 2 hours will be assisted by a timer Watch.
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.
Outcomes
Primary Outcome Measures
Change in Daytime incontinence-score
Incontinence-score calculated from Drypie scale between 0-21
Change in Relative number of wet nights
Number of wet nights pr week
Secondary Outcome Measures
Change in MVV (maximal voided volume)
maximal voided volume from bladder diary in ml
Change in Daytime urinary incontinence episodes (DUI episodes)
Daytime urinary incontinence episodes by bladder diary (episodes per day)
Full Information
NCT ID
NCT04260646
First Posted
July 18, 2019
Last Updated
February 3, 2023
Sponsor
Aalborg University Hospital
Collaborators
Aarhus University Hospital, Regional Hospital West Jutland, North Denmark Regional Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04260646
Brief Title
Alarm Treatment for Combined Enuresis and Daytime Urinary Incontinence in Children
Acronym
ABDE
Official Title
Enuresis Alarm for Treatment of Urinary Incontinence in Children With Combined Daytime Incontinence and Enuresis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
February 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University Hospital
Collaborators
Aarhus University Hospital, Regional Hospital West Jutland, North Denmark Regional Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incontinence, Urinary, Enuresis, Nocturnal, Enuresis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Urotherapy without enuresis alarm
Arm Type
Active Comparator
Arm Description
Standard urotherapy inclunding normalized fluid intake and times voidings. The timed voiding regime of every 2 hours will be assisted by a timer Watch.
Arm Title
Standard Urotherapy with enuresis alarm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Enuresis Alarm Rodger and Timer watch (Rodger)
Intervention Description
Nocturnal enuresis fluid sensitive alarm and Timer watch (Rodger) vibrating or sounding alarm for remembering timed voiding intervals
Intervention Type
Device
Intervention Name(s)
Timer watch (Rodger)
Intervention Description
Timer watch (Rodger) vibrating or sounding alarm for remembering timed voiding intervals
Primary Outcome Measure Information:
Title
Change in Daytime incontinence-score
Description
Incontinence-score calculated from Drypie scale between 0-21
Time Frame
Score will be calculated pre intervention, at week 2, 4, 6, and 8 of intervention
Title
Change in Relative number of wet nights
Description
Number of wet nights pr week
Time Frame
Will be calculated from registrations at baseline and week 8 of intervention
Secondary Outcome Measure Information:
Title
Change in MVV (maximal voided volume)
Description
maximal voided volume from bladder diary in ml
Time Frame
Will be calculated from 48h registrations at baseline and at week 8 of intervention
Title
Change in Daytime urinary incontinence episodes (DUI episodes)
Description
Daytime urinary incontinence episodes by bladder diary (episodes per day)
Time Frame
Will be calculated from 48h registrations at baseline and at week 8 of intervention
Other Pre-specified Outcome Measures:
Title
Change in fluid intake
Description
fluid intake from bladder diary (ml fluid per day)
Time Frame
Change in Fluid intake from 48h registrations at baseline and week 8 of intervention
Title
Change in enuresis time
Description
time of enuresis during night (timepoint)
Time Frame
Change in timepoint of enuresis from week1 to week8
Title
Change in number of enuresis episodes
Description
number of enuresis episodes (episodes per week)
Time Frame
Change in number of weekly enuresis measured one week at Baseline (before intervention) and week 8 of intervention i alarm group
Title
change in Nocturia frequency
Description
number of nocturia episodes/nights (nocturia episodes per night)
Time Frame
Change in number of nocturiaepisodes per night measured one week at Baseline (before intervention) and week 8 of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Dept pediatrics, Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
dept Pediatrics, Aarhus University Hospital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Børneafdelingen, Herning
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Facility Name
Dept pediatrics, North Denmark Regional Hospital Hjoerring Hjoerring
City
Hjørring
ZIP/Postal Code
9800
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Alarm Treatment for Combined Enuresis and Daytime Urinary Incontinence in Children
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