Enuresis Alarm - Is a Manual Trigger System Beneficial?
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Normal Group will use the alarm as provided by the manufacture. |
Behavioral: Normal
Will use the alarm as provided by the manufacture.
|
| Experimental: Manual trigger 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
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.
|
Outcome Measures
Primary Outcome Measures
- 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 [one year]
Bladder Diary (Participant self-reported)
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Iowa | Iowa City | Iowa | United States | 52242 |
Sponsors and Collaborators
- Gina Lockwood
- PottyMD
Investigators
- Principal Investigator: Gina M Lockwood, MD, MS, University of Iowa
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 201801703