Enuresis Alarm - Is a Manual Trigger System Beneficial?
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|ClinicalTrials.gov Identifier: NCT03522818|
Recruitment Status : Recruiting
First Posted : May 11, 2018
Last Update Posted : September 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Enuresis, Nocturnal||Behavioral: Manual Trigger Behavioral: Normal||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Enuresis Alarm - Is a Manual Trigger System Beneficial?|
|Actual Study Start Date :||March 9, 2018|
|Estimated Primary Completion Date :||March 12, 2021|
|Estimated Study Completion Date :||September 12, 2021|
Active Comparator: Normal
Group will use the alarm as provided by the manufacture.
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.
- 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)
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
|Contact: Gina M Lockwood, MD, MS||(319) firstname.lastname@example.org|
|United States, Iowa|
|University of Iowa||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Gina Lockwood, MD, MS 319-353-8673 email@example.com|
|Contact: Denise Juhr, BS (319) 356-1111 ext Juhr firstname.lastname@example.org|
|Principal Investigator: Gina Lockwood, MD|
|Principal Investigator:||Gina M Lockwood, MD, MS||University of Iowa|