Scheduled Awakenings for the Treatment of Nocturnal Enuresis

Nocturnal Enuresis Clinical Trial

Official title:

Scheduled Awakenings for the Treatment of Nocturnal Enuresis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03047720
• Other study ID #: 1601620278
• Status: Completed
• Phase: N/A
• Start date: November 4, 2016
• Est. completion date: August 7, 2018

Study information

• Verified date: October 2020
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a simple effectiveness trial to determine if the Lully Sleep Guardian has any effect on benign nocturnal enuresis.

Description:

Primary monosymptomatic nocturnal enuresis (PMNE) is defined by the Diagnostic & Statistical Manual of Mental Disorders (DSM- IV) as an involuntary voiding of urine during sleep, with a severity of at least twice a week, in children aged >5 years in the absence of congenital or acquired defects of the central nervous system(1-3).

PMNE affects 10-20% kids at 5 years old (1, 4, 5). It does resolve spontaneously so that 5% of 10 year olds and 1% of 15 year olds are still affected (2-4). Is more common in boys. While the disease its self is benign, and improves without intervention, it does pose a significant social and emotional burden on the child and their family. These include parental disapproval, sibling teasing, and inability to attend sleep overs with peers, all of which lead to families seeking treatment options (3, 4).

Current treatments start with conservative management. This includes appropriate fluid intake, scheduled toileting during the day, avoidance of bladder irritants and constipation (4, 5). If these fail to improve symptoms or families are looking for a more active form of treatment, first line therapy is either a bed wetting alarms or desmopressin (1, 4, 5).

The Lully Sleep Guardian was initially developed for use in night terrors. The device works by programing a vibrating disk that is placed under the child's bed to alter sleep patterns and prevent the onset of sleep terrors. The child is not woken up for the treatment of sleep terrors. The device has also been shown to anecdotally improve users' nocturnal enuresis. There have been no reports of safety concerns or hazards with the device (7, 8).

The aim of this study is to determine the effectiveness of scheduled awakenings, with the Lully Sleep Guardian, in patients with PMNE, at reducing the frequency of bed-wetting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 7, 2018
• Est. primary completion date: August 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

Inclusion Criteria:

• Benign nocturnal enuresis

• Age: 5 - 17

• Must have or have access to an Apple iPhone, iPad, or iPod Touch

Exclusion Criteria:

• Diurnal Enuresis

• Constipation

• Neurogenic Bladder

• Any serious underlying cardiopulmonary problems that require diuretics or antihypertensive medications to manage

• Any bladder active medications

• Age: < 5 years of age; > 17 years of age

• Cerebral Palsy

• Mental disorders, mood disorders, or autism-spectrum disorder

• Epilepsy or seizure history

• Restless leg syndrome

• Use of benzodiazepine/clonidine

Related Conditions & MeSH terms

• Enuresis
• Nocturnal Enuresis
• Urinary Incontinence

Intervention

Device:
• Lully Sleep Guardian
In the initial phase, participant baseline is established. In the Therapeutic Phase, each participant will complete the study phases (S1 and S2) in the order determined by their assigned treatment arm. During the scheduled awakening protocol using Lully Sleep Guardian, a scheduled awakening will be performed each night with the Lully pod. During the initial and therapeutic phases of this study, participants are asked to enter responses daily into a Lully Study app. The app will send a prompt each morning. The questions the participant is prompted to answer serve to document occurrence of bedwetting and the degree of wetness. In addition, the family will complete the KIDSCREEN 27 and the Vancouver questionnaire at defined intervals throughout the study.
• Lully Sleep Guardian
In the initial phase, participant baseline is established. In the Therapeutic Phase, each participant will complete the study phases (S1 and S2) in the order determined by their assigned treatment arm. During the scheduled awakening protocol using Lully Sleep Guardian, a scheduled awakening will be performed each night with the Lully pod. During the initial and therapeutic phases of this study, participants are asked to enter responses daily into a Lully Study app. The app will send a prompt each morning. The questions the participant is prompted to answer serve to document occurrence of bedwetting and the degree of wetness. In addition, the family will complete the KIDSCREEN 27 and the Vancouver questionnaire at defined intervals throughout the study.

Locations

Country	Name	City	State
United States	Riley Hopspital for Children	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

References & Publications (8)

1. National Clinical Guideline C. National Institute for Health and Clinical Excellence: Guidance. Nocturnal Enuresis: The Management of Bedwetting in Children and Young People. London: Royal College of Physicians (UK) National Clinical Guideline Centre.; 2010.

7.Rink A. Lully Sleep Guardian. In: Heinsimer K, editor. IU Health2016.

8. Lully Sleep Guardian - Proven to Stop Night Terrors: Amazon; 2016 [cited 2015 2016]. Available from: http://www.amazon.com/Lully-Sleep-Guardian-Proven-Terrors/dp/B011LOUNCI/ref=sr_1_1?ie=UTF8&qid=1457660065&sr=8-1-spons&keywords=lully+sleep+guardian&psc=1#customerReviews.

Ahmed AF, Amin MM, Ali MM, Shalaby EA. Efficacy of an enuresis alarm, desmopressin, and combination therapy in the treatment of saudi children with primary monosymptomatic nocturnal enuresis. Korean J Urol. 2013 Nov;54(11):783-90. doi: 10.4111/kju.2013.54.11.783. Epub 2013 Nov 6. — View Citation

Bayne AP, Skoog SJ. Nocturnal enuresis: an approach to assessment and treatment. Pediatr Rev. 2014 Aug;35(8):327-34; quiz 335. doi: 10.1542/pir.35-8-327. Review. — View Citation

Glazener CM, Evans JH, Peto RE. Alarm interventions for nocturnal enuresis in children. Cochrane Database Syst Rev. 2003;(2):CD002911. Review. Update in: Cochrane Database Syst Rev. 2005;(2):CD002911. — View Citation

Monda JM, Husmann DA. Primary nocturnal enuresis: a comparison among observation, imipramine, desmopressin acetate and bed-wetting alarm systems. J Urol. 1995 Aug;154(2 Pt 2):745-8. — View Citation

Önol FF, Guzel R, Tahra A, Kaya C, Boylu U. Comparison of long-term efficacy of desmopressin lyophilisate and enuretic alarm for monosymptomatic enuresis and assessment of predictive factors for success: a randomized prospective trial. J Urol. 2015 Feb;193(2):655-61. doi: 10.1016/j.juro.2014.08.088. Epub 2014 Aug 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Number of Dry Nights When Using the Scheduled Awakening Protocol With the Lully Sleep Guardian	Participants were asked to enter responses daily into a Lully Study app.The questions the participant was prompted to answer: Did your child have a bed wetting episode last night? Answered by yes or no.	baseline and 6 weeks (end of S1)
Primary	Change in Number of Voids Per Night When Using the Scheduled Awakening Protocol With the Lully Sleep Guardian	Participants were asked to enter responses daily into a Lully Study app.The questions the participant was prompted to answer: Did your child have a bed wetting episode last night? (Answered by yes or no) What time?	Not measured.
Primary	Change in Quantity of Wetness When Bedwetting Occurred While Using the Scheduled Awakening Protocol With the Lully	Participants were asked to enter responses daily into a Lully Study app. In a free text box the family was asked to add additional information to describe how wet the child was using the following 1-5 scale: 1- wet underwear; 2-wet underwear and damp pajamas; 3- soaked underwear, pajamas; 4-soaked pajamas, damp mattress; 5- soaked mattress.	Not measured.
Primary	QOL Measures Using the KIDS Screen Questionnaire at 10 Weeks	Participants were asked to complete QOL survey (KIDSCREEN 27) at baseline, before starting therapeutic phase, and after completing therapeutic phase. KIDSCREEN is a standardized questionnaire for children and adolescents to assess their health related quality of life (HRQoL). Each items scored on a 5-point scale. There is the KIDSCREEN 54 (long version) KIDSCREEN 27 (short version) KIDSCREEN 10 Index. For analysis, decision made to analyze questions in the KIDSCREEN 10 Index questions only. For KIDSCREEN 10, it is a 5 point Likert Scale with a score range of 10 to 50 with higher scores indicating better quality of life.	10 weeks