Clinical trial NCT03047720: Scheduled Awakenings for the Treatment of Nocturnal Enuresis
Official title: Scheduled Awakenings for the Treatment of Nocturnal Enuresis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nocturnal Enuresis
Keywords: bedwetting
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Number of Dry Nights When Using the Scheduled Awakening Protocol With the Lully Sleep Guardian
timeFrame: baseline and 6 weeks (end of S1)
measure: Change in Number of Voids Per Night When Using the Scheduled Awakening Protocol With the Lully Sleep Guardian
timeFrame: Not measured.
measure: Change in Quantity of Wetness When Bedwetting Occurred While Using the Scheduled Awakening Protocol With the Lully
timeFrame: Not measured.
measure: QOL Measures Using the KIDS Screen Questionnaire at 10 Weeks
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Hopspital for Children
state: Indiana
Study officials:
affiliation: Pediatric Urology, Riley Children's Hospital
name: Benjamin M Whittam, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: National Clinical Guideline Centre (UK). Nocturnal Enuresis: The Management of Bedwetting in Children and Young People. London: Royal College of Physicians (UK); 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK62712/
citation: 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.
citation: Glazener CM, Evans JH, Peto RE. Alarm interventions for nocturnal enuresis in children. Cochrane Database Syst Rev. 2003;(2):CD002911. doi: 10.1002/14651858.CD002911.
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.
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.
citation: Onol 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.
citation: 7.Rink A. Lully Sleep Guardian. In: Heinsimer K, editor. IU Health2016.
citation: 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.