Alarm Treatment for Combined Enuresis and Daytime Urinary Incontinence in Children

Study Overview
=================
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.

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

Conditions
-----------------
Incontinence, Urinary, Enuresis, Nocturnal, Enuresis

Intervention / Treatment
-----------------
* Device: Enuresis Alarm Rodger and Timer watch (Rodger)
* Device: Timer watch (Rodger)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Urotherapy without enuresis alarm<br>Standard urotherapy inclunding normalized fluid intake and times voidings. The timed voiding regime of every 2 hours will be assisted by a timer Watch. | Device: Timer watch (Rodger)<br>* Timer watch (Rodger) vibrating or sounding alarm for remembering timed voiding intervals<br>|
| Experimental: Standard Urotherapy with enuresis alarm<br>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. | Device: Enuresis Alarm Rodger and Timer watch (Rodger)<br>* Nocturnal enuresis fluid sensitive alarm and Timer watch (Rodger) vibrating or sounding alarm for remembering timed voiding intervals<br>Device: Timer watch (Rodger)<br>* Timer watch (Rodger) vibrating or sounding alarm for remembering timed voiding intervals<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |