Enuresis Alarm - Is a Manual Trigger System Beneficial?

G

Gina Lockwood

Status

Unknown

Conditions

Enuresis, Nocturnal

Treatments

Behavioral: Manual Trigger
Behavioral: Normal

Study type

Interventional

Funder types

Other

Identifiers

NCT03522818
201801703

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

5 to 15 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Normal
Active Comparator group
Description:
Group will use the alarm as provided by the manufacture.
Treatment:
Behavioral: Normal
Manual trigger
Experimental group
Description:
Group will use the same model but will be instructed to manually trigger the alarm 1-2 hours after the child falls asleep.
Treatment:
Behavioral: Manual Trigger

Trial contacts and locations

1

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Central trial contact

Gina M Lockwood, MD, MS

Data sourced from clinicaltrials.gov

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