Alarm Treatment for Combined Enuresis and Daytime Urinary Incontinence in Children

NCT04260646 | Completed DMC

• 1 other identifier: N-20170005
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 4

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.

Conditions

Incontinence, Urinary; Enuresis, Nocturnal; Enuresis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in MVV (maximal voided volume)

  Will be calculated from 48h registrations at baseline and at week 8 of intervention

• Change in Daytime urinary incontinence episodes (DUI episodes)

  Will be calculated from 48h registrations at baseline and at week 8 of intervention

Other Outcomes (4)

• Change in fluid intake

  Change in Fluid intake from 48h registrations at baseline and week 8 of intervention

• Change in enuresis time

  Change in timepoint of enuresis from week1 to week8

• Change in number of enuresis episodes

  Change in number of weekly enuresis measured one week at Baseline (before intervention) and week 8 of intervention i alarm group

Study Arms (2)

Standard Urotherapy without enuresis alarm

ACTIVE COMPARATOR

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)

Standard Urotherapy with enuresis alarm

EXPERIMENTAL

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); Device: Timer watch (Rodger)

Interventions

Enuresis Alarm Rodger and Timer watch (Rodger) DEVICE

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

Standard Urotherapy with enuresis alarm

Timer watch (Rodger) DEVICE

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

Standard Urotherapy with enuresis alarm; Standard Urotherapy without enuresis alarm

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Aarhus University Hospital: collaborator
• Regional Hospital West Jutland: collaborator
• Regionshospital Nordjylland: collaborator

Study Sites (4)

Dept pediatrics, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

dept Pediatrics, Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

Børneafdelingen, Herning

Herning, 7400, Denmark

Location

Dept pediatrics, North Denmark Regional Hospital Hjoerring Hjoerring

Hjørring, 9800, Denmark

Location

MeSH Terms

Conditions

Urinary Incontinence; Nocturnal Enuresis; Enuresis

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: February 7, 2020
• Study Start: May 1, 2017
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

DK (4)