Nocturnal Enuresis
Conditions
Keywords
bedwetting
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.
Interventions
DEVICELully 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.
Sponsors
Indiana University
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Number of Dry Nights When Using the Scheduled Awakening Protocol With the Lully Sleep Guardian | baseline and 6 weeks (end of S1) | 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. |
| Change in Number of Voids Per Night When Using the Scheduled Awakening Protocol With the Lully Sleep Guardian | Not measured. | 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? |
| Change in Quantity of Wetness When Bedwetting Occurred While Using the Scheduled Awakening Protocol With the Lully | Not measured. | 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. |
| QOL Measures Using the KIDS Screen Questionnaire at 10 Weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lully Device First, Then No Device Lully device plus Behavioral modifications plus for daily for 6 weeks (S1), followed behavioral modifications only without the device daily for 6week (S2)
No washout period between S1 and S2 because there was no carryover effect from either intervention | 12 |
| No Device First, Then Lully Device Behavioral modifications only without the device (S2) daily for 6weeks, followed by of behavioral modifications plus use of the Lully device daily for 6 weeks(S1)
No washout period between S2 and S1 because there was no carryover effect from either intervention | 0 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (6weeks) | Participant data entry insufficient | 7 | 0 |
Baseline characteristics
| Characteristic | Lully Device First, Then No Device | Total | No Device First, Then Lully Device |
|---|---|---|---|
| Age, Categorical <=18 years | 12 Participants | 12 Participants | — |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | — |
| Race (NIH/OMB) White | 11 Participants | 11 Participants | — |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 0 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 0 Participants |
| Vancouver Questionnaire Score | 9.28 units on a scale STANDARD_DEVIATION 3.1 | 9.28 units on a scale STANDARD_DEVIATION 3.1 | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 0 |
| other Total, other adverse events | 0 / 12 | 0 / 0 |
| serious Total, serious adverse events | 0 / 12 | 0 / 0 |
Outcome results
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.
Time frame: baseline and 6 weeks (end of S1)
Population: Participants who completed at least 37 nights of data entry using the scheduled awakening protocol with the Lully Sleep Guardian
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Lully Device | Change in Number of Dry Nights When Using the Scheduled Awakening Protocol With the Lully Sleep Guardian | -0.67 difference in number of dry nights |
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?
Time frame: Not measured.
Population: Unable to measure because data was not collected.
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.
Time frame: Not measured.
Population: No participant were analyzed. Data was not available. Contributors: data not entered by participants and app glitches could have lead to lost data if entered
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.
Time frame: 10 weeks
Population: Patients analyzed completed the KIDSCREEN after completing the 6 weeks use of the Lully device. 4 of 5 who completed the 6 weeks use the Lully device completed the KIDSCREEN. Data was not collected for Baseline and 4 wk scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lully Device | QOL Measures Using the KIDS Screen Questionnaire at 10 Weeks | 42.75 score on a scale | Standard Deviation 5.97 |