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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| Regional Hospital West Jutland | OTHER |
| Regionshospital Nordjylland | OTHER_GOV |
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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.
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fluid intake | fluid intake from bladder diary (ml fluid per day) | Change in Fluid intake from 48h registrations at baseline and week 8 of intervention |
| Change in enuresis time | time of enuresis during night (timepoint) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept pediatrics, Aalborg University Hospital | Aalborg | 9000 | Denmark | |||
| dept Pediatrics, Aarhus University Hospital |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D053206 | Nocturnal Enuresis |
| D004775 | Enuresis |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Randomized controlled trial
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| Timer watch (Rodger) | Device | Timer watch (Rodger) vibrating or sounding alarm for remembering timed voiding intervals |
|
Daytime urinary incontinence episodes by bladder diary (episodes per day)
| Will be calculated from 48h registrations at baseline and at week 8 of intervention |
| Change in timepoint of enuresis from week1 to week8 |
| Change in number of enuresis episodes | number of enuresis episodes (episodes per week) | Change in number of weekly enuresis measured one week at Baseline (before intervention) and week 8 of intervention i alarm group |
| change in Nocturia frequency | number of nocturia episodes/nights (nocturia episodes per night) | Change in number of nocturiaepisodes per night measured one week at Baseline (before intervention) and week 8 of intervention |
| Aarhus N |
| 8200 |
| Denmark |
| Børneafdelingen, Herning | Herning | 7400 | Denmark |
| Dept pediatrics, North Denmark Regional Hospital Hjoerring Hjoerring | Hjørring | 9800 | Denmark |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019960 | Elimination Disorders |
| D001523 | Mental Disorders |