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Alarm Treatment for Combined Enuresis and Daytime Urinary Incontinence in Children (ABDE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04260646
Recruitment Status : Recruiting
First Posted : February 7, 2020
Last Update Posted : February 7, 2020
Sponsor:
Collaborators:
Aarhus University Hospital
Regional Hospital West Jutland
North Denmark Regional Hospital
Information provided by (Responsible Party):
Søren Hagstrøm, MD PhD, Aalborg University Hospital

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.

Condition or disease Intervention/treatment Phase
Incontinence, Urinary Enuresis, Nocturnal Enuresis Device: Enuresis Alarm Rodger and Timer watch (Rodger) Device: Timer watch (Rodger) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enuresis Alarm for Treatment of Urinary Incontinence in Children With Combined Daytime Incontinence and Enuresis
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Device: Timer watch (Rodger)
Timer watch (Rodger) vibrating or sounding alarm for remembering timed voiding intervals

Experimental: 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.
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




Primary Outcome Measures :
  1. Change in Daytime incontinence-score [ Time Frame: Score will be calculated pre intervention, at week 2, 4, 6, and 8 of intervention ]
    Incontinence-score calculated from Drypie scale between 0-21

  2. Change in Relative number of wet nights [ Time Frame: Will be calculated from registrations at baseline and week 8 of intervention ]
    Number of wet nights pr week


Secondary Outcome Measures :
  1. Change in MVV (maximal voided volume) [ Time Frame: Will be calculated from 48h registrations at baseline and at week 8 of intervention ]
    maximal voided volume from bladder diary in ml

  2. Change in Daytime urinary incontinence episodes (DUI episodes) [ Time Frame: Will be calculated from 48h registrations at baseline and at week 8 of intervention ]
    Daytime urinary incontinence episodes by bladder diary (episodes per day)


Other Outcome Measures:
  1. Change in fluid intake [ Time Frame: Change in Fluid intake from 48h registrations at baseline and week 8 of intervention ]
    fluid intake from bladder diary (ml fluid per day)

  2. Change in enuresis time [ Time Frame: Change in timepoint of enuresis from week1 to week8 ]
    time of enuresis during night (timepoint)

  3. Change in number of enuresis episodes [ Time Frame: Change in number of weekly enuresis measured one week at Baseline (before intervention) and week 8 of intervention i alarm group ]
    number of enuresis episodes (episodes per week)

  4. change in Nocturia frequency [ Time Frame: Change in number of nocturiaepisodes per night measured one week at Baseline (before intervention) and week 8 of intervention ]
    number of nocturia episodes/nights (nocturia episodes per night)



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04260646


Locations
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Denmark
Dept pediatrics, Aalborg University Hospital Recruiting
Aalborg, Denmark, 9000
Contact: Birgitte Ryom    +4597663344    borneinkontinens@rn.dk   
Contact: Soeren Hagstroem, MD, PhD    +4597663400    soha@rn.dk   
dept Pediatrics, Aarhus University Hospital Not yet recruiting
Aarhus N, Denmark, 8200
Contact: Konstantinos Kamperis, Md PhD    +78450000    kostas.kamperis@clin.au.dk   
Børneafdelingen, Herning Recruiting
Herning, Denmark, 7400
Contact: Luise Borch, MD PhD    ++45 7843 0000    luise.borch@rm.dk   
Dept pediatrics, North Denmark Regional Hospital Hjoerring Hjoerring Recruiting
Hjørring, Denmark, 9800
Contact: Qing Chai, MD PhD    +4597641007    q.chai@rn.dk   
Sponsors and Collaborators
Aalborg University Hospital
Aarhus University Hospital
Regional Hospital West Jutland
North Denmark Regional Hospital

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Responsible Party: Søren Hagstrøm, MD PhD, Consultant, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT04260646    
Other Study ID Numbers: N-20170005
First Posted: February 7, 2020    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Nocturnal Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders