Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Enuresis Alarm - Is a Manual Trigger System Beneficial?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03522818
Recruitment Status : Recruiting
First Posted : May 11, 2018
Last Update Posted : October 12, 2018
Sponsor:
Collaborator:
PottyMD
Information provided by (Responsible Party):
Gina Lockwood, University of Iowa

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.

Condition or disease Intervention/treatment Phase
Enuresis, Nocturnal Behavioral: Manual Trigger Behavioral: Normal Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enuresis Alarm - Is a Manual Trigger System Beneficial?
Actual Study Start Date : March 9, 2018
Estimated Primary Completion Date : March 12, 2019
Estimated Study Completion Date : September 12, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Normal
Group will use the alarm as provided by the manufacture.
Behavioral: Normal
Will use the alarm as provided by the manufacture.

Experimental: 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.
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.




Primary Outcome Measures :
  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 [ Time Frame: one year ]
    Bladder Diary (Participant self-reported)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522818


Contacts
Layout table for location contacts
Contact: Gina M Lockwood, MD, MS (319) 353-8673 gina-lockwood@uiowa.edu

Locations
Layout table for location information
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Gina Lockwood, MD, MS    319-353-8673    gina-lockwood@uiowa.edu   
Contact: Denise Juhr, BS    (319) 356-1111 ext Juhr    denise-juhr@uiowa.edu   
Principal Investigator: Gina Lockwood, MD         
Sponsors and Collaborators
Gina Lockwood
PottyMD
Investigators
Layout table for investigator information
Principal Investigator: Gina M Lockwood, MD, MS University of Iowa

Layout table for additonal information
Responsible Party: Gina Lockwood, Principal Investigator, Medical Doctor, University of Iowa
ClinicalTrials.gov Identifier: NCT03522818     History of Changes
Other Study ID Numbers: 201801703
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Enuresis
Urinary Incontinence
Nocturnal Enuresis
Urination Disorders
Urologic Diseases
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms