Alarm Treatment for Combined Enuresis and Daytime Urinary Incontinence in Children

NCT ID: NCT04260646

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2023-02-28

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.

Conditions

Incontinence, Urinary; Enuresis, Nocturnal; Enuresis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Urotherapy without enuresis alarm

Standard urotherapy inclunding normalized fluid intake and times voidings. The timed voiding regime of every 2 hours will be assisted by a timer Watch.

Group Type: ACTIVE_COMPARATOR

Timer watch (Rodger)

Intervention Type: DEVICE

Timer watch (Rodger) vibrating or sounding alarm for remembering timed voiding intervals

Standard Urotherapy with enuresis alarm

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.

Group Type: EXPERIMENTAL

Enuresis Alarm Rodger and Timer watch (Rodger)

Intervention Type: DEVICE

Nocturnal enuresis fluid sensitive alarm and Timer watch (Rodger) vibrating or sounding alarm for remembering timed voiding intervals

Timer watch (Rodger)

Intervention Type: DEVICE

Timer watch (Rodger) vibrating or sounding alarm for remembering timed voiding intervals

Interventions

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

Intervention Type: DEVICE

Timer watch (Rodger)

Timer watch (Rodger) vibrating or sounding alarm for remembering timed voiding intervals

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

Regional Hospital West Jutland

OTHER

Sponsor Role: collaborator

Regionshospital Nordjylland

OTHER_GOV

Sponsor Role: collaborator

Aalborg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Søren Hagstrøm, MD PhD

Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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, , Denmark

Countries

Denmark

Other Identifiers

N-20170005

Identifier Type: -

Identifier Source: org_study_id