Scheduled Awakenings for the Treatment of Nocturnal Enuresis

NCT03047720 | Completed Results FDA Device

• 1 other identifier: 1601620278
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nocturnal Enuresis

Keywords

bedwetting

Outcome Measures

Primary Outcomes (4)

• 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)

• 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.

• 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.

• 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

Study Arms (2)

One: Study Phases (S1 and S2)

OTHER

The therapeutic phase of this study for the participant in Arm One will be: 6 weeks of behavioral modifications plus the Lully device (S1), followed by 6 weeks of behavioral modifications only without the device (S2)

Device: Lully Sleep Guardian

Two: Study Phases (S2 and S1)

OTHER

The therapeutic phase of this study for the participant in Arm Two will be: 6 weeks of behavioral modifications only without the device (S2), followed by 6 weeks of behavioral modifications plus use of the Lully device(S1)

Device: Lully Sleep Guardian

Interventions

Lully Sleep Guardian DEVICE

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.

One: Study Phases (S1 and S2)

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Benign nocturnal enuresis
• Age: 5 - 17
• Must have or have access to an Apple iPhone, iPad, or iPod Touch

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Riley Hopspital for Children

Indianapolis, Indiana, 46202, United States

Location

Related Publications (8)

• 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/

  PMID: 22031959 BACKGROUND

• 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.

  PMID: 24255762 BACKGROUND

• 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.

  PMID: 12804443 BACKGROUND

• 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.

  PMID: 25086164 BACKGROUND

• 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.

  PMID: 7609169 BACKGROUND

• 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.

  PMID: 25158273 BACKGROUND

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

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Nocturnal Enuresis

Condition Hierarchy (Ancestors)

Enuresis; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Limitations and Caveats

Study N too small to perform statistical analysis. Limits included decreased bedwetting during baseline, inconsistent user data entry in app, app glitches, lack of participant interest in proceeding to S2 after completing S1. Study ended early.

Results Point of Contact

• Title: Dr Benjamin Whittam
• Organization: Indiana University

bwhittam@iupui.edu

317.944.8896

Study Officials

• Benjamin M Whittam, MD

  Pediatric Urology, Riley Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Urology

Study Record Dates

• First Submitted: December 28, 2016
• First Posted: February 9, 2017
• Study Start: November 4, 2016
• Primary Completion: August 7, 2018
• Study Completion: August 7, 2018
• Last Updated: November 17, 2020
• Results First Posted: October 19, 2020

Record last verified: 2020-10

Locations

US (1)