Alarm Treatment for Combined Enuresis and Daytime Urinary Incontinence in Children

Incontinence, Urinary Clinical Trial

— ABDE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04260646
• Other study ID #: N-20170005
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: February 28, 2023

Study information

• Verified date: March 2024
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Enuresis, Nocturnal
• Incontinence, Urinary
• Nocturnal Enuresis
• Urinary Incontinence

Intervention

Device:
• Enuresis Alarm Rodger and Timer watch (Rodger)
Nocturnal enuresis fluid sensitive alarm and Timer watch (Rodger) vibrating or sounding alarm for remembering timed voiding intervals
• Timer watch (Rodger)
Timer watch (Rodger) vibrating or sounding alarm for remembering timed voiding intervals

Locations

Country	Name	City	State
Denmark	Dept pediatrics, Aalborg University Hospital	Aalborg
Denmark	dept Pediatrics, Aarhus University Hospital	Aarhus N
Denmark	Børneafdelingen, Herning	Herning
Denmark	Dept pediatrics, North Denmark Regional Hospital Hjoerring Hjoerring	Hjørring

Sponsors (4)

Lead Sponsor	Collaborator
Aalborg University Hospital	Aarhus University Hospital, North Denmark Regional Hospital, Regional Hospital West Jutland

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in fluid intake	fluid intake from bladder diary (ml fluid per day)	Change in Fluid intake from 48h registrations at baseline and week 8 of intervention
Other	Change in enuresis time	time of enuresis during night (timepoint)	Change in timepoint of enuresis from week1 to week8
Other	Change in number of enuresis episodes	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
Other	change in Nocturia frequency	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
Primary	Change in Daytime incontinence-score	Incontinence-score calculated from Drypie scale between 0-21	Score will be calculated pre intervention, at week 2, 4, 6, and 8 of intervention
Primary	Change in Relative number of wet nights	Number of wet nights pr week	Will be calculated from registrations at baseline and week 8 of intervention
Secondary	Change in MVV (maximal voided volume)	maximal voided volume from bladder diary in ml	Will be calculated from 48h registrations at baseline and at week 8 of intervention
Secondary	Change in Daytime urinary incontinence episodes (DUI episodes)	Daytime urinary incontinence episodes by bladder diary (episodes per day)	Will be calculated from 48h registrations at baseline and at week 8 of intervention