Enuresis Alarm - Is a Manual Trigger System Beneficial?

Study Overview
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Brief Summary
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The purpose of this study is to evaluate whether the bedwetting alarm trigger activated by parents to wake their child, in addition to the moisture alarm, will improve treatment success compared to the moisture alarm alone.

Detailed Description
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Nocturnal enuresis is a common issue in children, and use of bedwetting alarms has shown the best long-term success. However, use of alarms is very time-intensive, often taking months before yielding results. Researchers in the division of pediatric urology are initiating a randomized controlled study comparing a standard bedwetting alarm with a newly developed technology, with the hope that the new alarm will result in better, more rapid, and easier treatment for bedwetting. Children between the ages of 5 to 15 years old who have issues with bedwetting after successful toilet training may qualify for the study. Participants must first be evaluated by a pediatric urology specialist.

Official Title
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Enuresis Alarm - Is a Manual Trigger System Beneficial?

Conditions
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Enuresis, Nocturnal

Intervention / Treatment
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* Behavioral: Manual Trigger
* Behavioral: Normal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children ages 5-15 years Diagnosis of Primary Monosymptomatic Nocturnal Enuresis >2 wet nights per week Score of 7 or below on questions 1-6 and 9-13 on Vancouver Dysfunctional Elimination Questionnaire Patients/parents compliance in recording data > 50% of nights Exclusion Criteria: Known comorbid conditions: daytime incontinence, anatomic abnormalities (hydronephrosis, VUR), recurrent urinary tract infection, dysuria, neurogenic bladder, developmental delay, encopresis, diabetes insipidus, previous history of urologic surgery Concomitant DDAVP use, anticholinergic use, B3 agonist use

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Normal<br>Group will use the alarm as provided by the manufacture. | Behavioral: Normal<br>* Will use the alarm as provided by the manufacture.<br>|
| Experimental: Manual trigger<br>Group will use the same model but will be instructed to manually trigger the alarm 1-2 hours after the child falls asleep. | Behavioral: Manual Trigger<br>* Will use the alarm as provided by the manufacture but parent has to manual trigger the alarm 1-2 hours after the child falls asleep.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the change and % reduction in mean number wet nights/week (>90%, 50-89%, <50%) of patients with treatment success with use of a manual trigger + moisture alarm vs. moisture alarm only | Bladder Diary (Participant self-reported) | one year |