Enuresis Alarm - Is a Manual Trigger System Beneficial?

NCT03522818 | Unknown

• 1 other identifier: 201801703
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Enuresis, Nocturnal

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Normal

ACTIVE COMPARATOR

Group will use the alarm as provided by the manufacture.

Behavioral: Normal

Manual trigger

EXPERIMENTAL

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

Interventions

Manual Trigger 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.

Manual trigger

Normal BEHAVIORAL

Will use the alarm as provided by the manufacture.

Normal

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gina Lockwood: lead
• PottyMD: collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

MeSH Terms

Conditions

Nocturnal Enuresis

Condition Hierarchy (Ancestors)

Enuresis; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Officials

• Gina M Lockwood, MD, MS

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gina M Lockwood, MD, MS

CONTACT

(319) 353-8673; gina-lockwood@uiowa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Medical Doctor

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: May 11, 2018
• Study Start: March 9, 2018
• Primary Completion: March 12, 2023
• Study Completion: September 12, 2023
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)