Clinical trial NCT04260646: Alarm Treatment for Combined Enuresis and Daytime Urinary Incontinence in Children
Official title: Enuresis Alarm for Treatment of Urinary Incontinence in Children With Combined Daytime Incontinence and Enuresis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incontinence, Urinary
Enuresis, Nocturnal
Enuresis
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Regional Hospital West Jutland
name: Regionshospital Nordjylland
First posted: 2020-02-07
Enrollment: 89
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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:

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.

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.

Primary outcomes:
measure: Change in Daytime incontinence-score
timeFrame: Score will be calculated pre intervention, at week 2, 4, 6, and 8 of intervention
measure: Change in Relative number of wet nights
timeFrame: Will be calculated from registrations at baseline and week 8 of intervention
Secondary outcomes:
measure: Change in MVV (maximal voided volume)
timeFrame: Will be calculated from 48h registrations at baseline and at week 8 of intervention
measure: Change in Daytime urinary incontinence episodes (DUI episodes)
timeFrame: Will be calculated from 48h registrations at baseline and at week 8 of intervention
Other outcomes:
measure: Change in fluid intake
timeFrame: Change in Fluid intake from 48h registrations at baseline and week 8 of intervention
measure: Change in enuresis time
timeFrame: Change in timepoint of enuresis from week1 to week8
measure: Change in number of enuresis episodes
timeFrame: Change in number of weekly enuresis measured one week at Baseline (before intervention) and week 8 of intervention i alarm group
measure: change in Nocturia frequency
timeFrame: Change in number of nocturiaepisodes per night measured one week at Baseline (before intervention) and week 8 of intervention
Locations:
city: Aalborg
country: Denmark
facility: Dept pediatrics, Aalborg University Hospital
city: Aarhus N
country: Denmark
facility: dept Pediatrics, Aarhus University Hospital
city: Herning
country: Denmark
facility: Børneafdelingen, Herning
city: Hjørring
country: Denmark
facility: Dept pediatrics, North Denmark Regional Hospital Hjoerring Hjoerring
Study officials:
References: