Nocturnal Enuresis and Rapid Maxillary Expansion

Study Overview
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Brief Summary
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Nocturnal enuresis (NE) is the involuntary loss of urine that occurs only at night in children aged 5 years or more. NE is a common problem, affecting about 10% of school children. The prevalence declines with each year of maturity but for some it persists in to adolescents and early adulthood. It can lead to bad self-confidence and low self-esteem, which can have psychosocial consequences. NE is a multifactorial condition. Three central factors have been identified: A) Many bedwetting children produce large amounts of urine at night due to a deficiency of the antidiuretic hormone vasopressin. B) Other children have a lack of inhibition of bladder emptying during sleep. C) Almost all children are deep sleepers with high arousal thresholds. They simply don't wake up when the bladder is full or when it contracts. There are two well established and evidence based treatments today: the bed-wetting alarm and the pharmacologic treatment desmopressin. The alarm emits a sound when the child wets the bed, which conditions the child to wake up or inhibit bladder emptying. This method is curative for about half of the patients who try this, but relapse occurs. Desmopressin is a synthetic analog of arginine vasopressin and works by decreasing the urine volume at night. About half of the patients become dry with this medication but only as long as they take the medicine. To day, at least 25% of all children with NE do not respond to any of the above treatment. Rapid maxillary expansion (RME) is a common orthodontic technique to treat patients with a narrow upper jaw. The brace is fitted by an orthodontist, and has a jack-screw, which is activated twice every day for 10-14 days. The procedure is neither painful nor harmful and is not very visible at all. There are a few reports about children who have become dry after RME treatment. None of them have been randomised or placebo controlled but indicates that quite a few children do become dry after this treatment. A recently carried out study in Sweden show that half of the children became dry after RME treatment. These children were all classed as therapy resistant and had already tried the alarm and medication without success. The reports are intriguing, but invite the question why a brace would help cure NE? It is likely that sleep and respiration is involved. This study will investigate these children's sleep during the treatment. The trial is a randomised, placebo controlled trial.

Official Title
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Nocturnal Enuresis and Rapid Maxillary Expansion - Long Term Effect, Prognostic Factors, Quality of Life and Sleep Quality

Conditions
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Nocturnal Enuresis

Intervention / Treatment
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* Device: Rapid Maxillary Expansion
* Device: Placebo Appliance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 7-14 years old At least 7 wet nights out of 14 Exclusion Criteria: Daytime incontinence Constipation ADHD

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Rapid Maxillary Expansion
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rapid Maxillary Expansion<br>A Rapid Maxillary Expander will be fitted and the palate will be expanded approximately 5mm. | Device: Rapid Maxillary Expansion<br>* The Rapid Maxillary Expander will over 10-14 days create a palatal expansion of about 5mm.<br>* Other names: Hyrax screw;|
| Placebo Comparator: Placebo group<br>A Sham appliance is fitted and activated for 10-14 days. The patients in this group will after it has been revealed they were randomized into the placebo group have a true Rapid Maxillary Expander fitted and the palate will be expanded approximately 5 mm. | Device: Placebo Appliance<br>* The Placebo Appliance looks exactly like the Rapid maxillary Expander but the expansion screw does not work. When the expansion screw is activated it does not create a palatal expansion.<br>* Other names: Sham Device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enuresis frequency | Number of wet night | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QoL | The validated quality of life questionnaire Paediatric Incontinence Questionnaire | Baseline, 6 months | 
| QoL | The validated quality of life questionnaire OSA 18 | Baseline, 1 month, 6 months | 
| Sleep quality | Polygraphic sleep recordings will be carried out at 3 time points during the study | Baseline, 1 month, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nocturnal Enuresis, Rapid Maxillary Expansion, Orthodontics, Polysomnography, Quality of life