Enuresis Alarm - Is a Manual Trigger System Beneficial?
Primary Purpose
Enuresis, Nocturnal
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Manual Trigger
Normal
Sponsored by
About this trial
This is an interventional treatment trial for Enuresis, Nocturnal
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
Sites / Locations
- University of IowaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Normal
Manual trigger
Arm Description
Group will use the alarm as provided by the manufacture.
Group will use the same model but will be instructed to manually trigger the alarm 1-2 hours after the child falls asleep.
Outcomes
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
Bladder Diary (Participant self-reported)
Secondary Outcome Measures
Full Information
NCT ID
NCT03522818
First Posted
March 16, 2018
Last Updated
April 27, 2021
Sponsor
Gina Lockwood
Collaborators
PottyMD
1. Study Identification
Unique Protocol Identification Number
NCT03522818
Brief Title
Enuresis Alarm - Is a Manual Trigger System Beneficial?
Official Title
Enuresis Alarm - Is a Manual Trigger System Beneficial?
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 9, 2018 (Actual)
Primary Completion Date
March 12, 2023 (Anticipated)
Study Completion Date
September 12, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gina Lockwood
Collaborators
PottyMD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enuresis, Nocturnal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Normal
Arm Type
Active Comparator
Arm Description
Group will use the alarm as provided by the manufacture.
Arm Title
Manual trigger
Arm Type
Experimental
Arm Description
Group will use the same model but will be instructed to manually trigger the alarm 1-2 hours after the child falls asleep.
Intervention Type
Behavioral
Intervention Name(s)
Manual Trigger
Intervention Description
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
Intervention Name(s)
Normal
Intervention Description
Will use the alarm as provided by the manufacture.
Primary Outcome Measure Information:
Title
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
Description
Bladder Diary (Participant self-reported)
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gina M Lockwood, MD, MS
Phone
(319) 353-8673
Email
gina-lockwood@uiowa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gina M Lockwood, MD, MS
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gina Lockwood, MD, MS
Phone
319-353-8673
Email
gina-lockwood@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Denise Juhr, BS
Phone
(319) 356-1111
Ext
Juhr
Email
denise-juhr@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Gina Lockwood, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Enuresis Alarm - Is a Manual Trigger System Beneficial?
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