Enuresis Alarm - Is a Manual Trigger System Beneficial?

NCT ID: NCT03522818

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-09
• Study Completion Date: 2023-09-12

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.

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.

Conditions

Enuresis, Nocturnal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Normal

Group will use the alarm as provided by the manufacture.

Group Type: ACTIVE_COMPARATOR

Normal

Intervention Type: BEHAVIORAL

Will use the alarm as provided by the manufacture.

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.

Group Type: EXPERIMENTAL

Manual Trigger

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Normal

Will use the alarm as provided by the manufacture.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PottyMD

UNKNOWN

Sponsor Role: collaborator

Gina Lockwood

OTHER

Sponsor Role: lead

Responsible Party

Gina Lockwood

Principal Investigator, Medical Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gina M Lockwood, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa

Iowa City, Iowa, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Gina M Lockwood, MD, MS

Role: CONTACT

gina-lockwood@uiowa.edu

(319) 353-8673

Facility Contacts

Gina Lockwood, MD, MS

Role: primary

gina-lockwood@uiowa.edu

319-353-8673

Denise Juhr, BS

Role: backup

denise-juhr@uiowa.edu

(319) 356-1111 ext. Juhr

Other Identifiers

201801703

Identifier Type: -

Identifier Source: org_study_id