NCT04260646

Alarm Treatment for Combined Enuresis and Daytime Urinary Incontinence in Children

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Aalborg University Hospital · Academic / Other
• Sex: All
• Age: 5 Years – 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Incontinence, Urinary
• Enuresis, Nocturnal
• Enuresis

Interventions

Type	Name	Description
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
DEVICE	Timer watch (Rodger)	Timer watch (Rodger) vibrating or sounding alarm for remembering timed voiding intervals

Timeline

• Start date: 2017-05-01
• Primary completion: 2023-02-28
• Completion: 2023-02-28
• First posted: 2020-02-07
• Last updated: 2024-03-12

Locations

4 sites across 1 country: Denmark