Enuresis Alarm - Is a Manual Trigger System Beneficial?

Enuresis, Nocturnal Clinical Trial

Official title:

Enuresis Alarm - Is a Manual Trigger System Beneficial?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03522818
• Other study ID #: 201801703
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2018
• Est. completion date: September 12, 2023

Study information

• Verified date: April 2021
• Source: University of Iowa
• Contact: Gina M Lockwood, MD, MS
• Phone: (319) 353-8673
• Email: gina-lockwood[@]uiowa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 12, 2023
• Est. primary completion date: March 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Enuresis, Nocturnal
• Nocturnal Enuresis
• Urinary Incontinence

Intervention

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.
• Normal
Will use the alarm as provided by the manufacture.

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Gina Lockwood	PottyMD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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