Clinical trial NCT02178826: Nocturnal Enuresis and Rapid Maxillary Expansion
Official title: Nocturnal Enuresis and Rapid Maxillary Expansion - Long Term Effect, Prognostic Factors, Quality of Life and Sleep Quality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nocturnal Enuresis
Keywords: Nocturnal Enuresis
Rapid Maxillary Expansion
Orthodontics
Polysomnography
Quality of life
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
Collaborators: name: Örebro County Council
name: Uppsala County Council, Sweden
First posted: 2014-07-01
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Rapid Maxillary Expansion
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients aged 7-14 years old
* At least 7 wet nights out of 14

Exclusion Criteria:

* Daytime incontinence
* Constipation
* ADHD

Primary outcomes:
measure: Enuresis frequency
timeFrame: 6 months
Secondary outcomes:
measure: QoL
timeFrame: Baseline, 6 months
measure: QoL
timeFrame: Baseline, 1 month, 6 months
measure: Sleep quality
timeFrame: Baseline, 1 month, 6 months
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Folktandvården Uppsala län
state: Uppland
Study officials:
affiliation: Uppsala University Hospital
name: Ingrid M Jönson Ring, DDS, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Örebro County Council
name: Farhan Bazargani, DDS, PhD
role: STUDY_DIRECTOR
affiliation: Uppsala University Hospital
name: Tryggve Nevéus, MD, PhD
role: STUDY_CHAIR
References:
citation: Bower WF, Moore KH, Shepherd RB, Adams RD. The epidemiology of childhood enuresis in Australia. Br J Urol. 1996 Oct;78(4):602-6. doi: 10.1046/j.1464-410x.1996.13618.x.
citation: Neveus T. Nocturnal enuresis-theoretic background and practical guidelines. Pediatr Nephrol. 2011 Aug;26(8):1207-14. doi: 10.1007/s00467-011-1762-8. Epub 2011 Jan 26.
citation: Timms DJ. Rapid maxillary expansion in the treatment of nocturnal enuresis. Angle Orthod. 1990 Fall;60(3):229-33; discussion 234. doi: 10.1043/0003-3219(1990)0602.0.CO;2.
citation: Kurol J, Modin H, Bjerkhoel A. Orthodontic maxillary expansion and its effect on nocturnal enuresis. Angle Orthod. 1998 Jun;68(3):225-32. doi: 10.1043/0003-3219(1998)0682.3.CO;2.
citation: Usumez S, Iseri H, Orhan M, Basciftci FA. Effect of rapid maxillary expansion on nocturnal enuresis. Angle Orthod. 2003 Oct;73(5):532-8. doi: 10.1043/0003-3219(2003)0732.0.CO;2.
citation: Schutz-Fransson U, Kurol J. Rapid maxillary expansion effects on nocturnal enuresis in children: a follow-up study. Angle Orthod. 2008 Mar;78(2):201-8. doi: 10.2319/021407-71.1.