Nocturnal Enuresis and Rapid Maxillary Expansion
Information source: Uppsala University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nocturnal Enuresis
Intervention: Rapid Maxillary Expansion (Device)
Phase: N/A
Status: Recruiting
Sponsored by: Uppsala University Hospital Official(s) and/or principal investigator(s): Ingrid M Jönson Ring, DDS, MSc, Principal Investigator, Affiliation: Uppsala University Hospital Farhan Bazargani, DDS, PhD, Study Director, Affiliation: Örebro County Council Tryggve Nevéus, MD, PhD, Study Chair, Affiliation: Uppsala University Hospital
Overall contact: Ingrid M Jönson Ring, DDS, MSc, Phone: +46733357733, Email: ingrid.jonson_ring@kbh.uu.se
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.
Clinical Details
Official title: Nocturnal Enuresis and Rapid Maxillary Expansion - Long Term Effect, Prognostic Factors, Quality of Life and Sleep Quality
Study design: Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Number of wet night
Secondary outcome: Quality of lifeSleep quality
Eligibility
Minimum age: 7 Years.
Maximum age: 14 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients aged 7-14 years old
- At least 7 wet nights out of 14
Exclusion Criteria:
- Daytime incontinence
- Constipation
- ADHD
Locations and Contacts
Ingrid M Jönson Ring, DDS, MSc, Phone: +46733357733, Email: ingrid.jonson_ring@kbh.uu.se
Folktandvården Uppsala län, Uppsala, Uppland 75322, Sweden; Recruiting Ingrid M Jönson Ring, DDS, MSc, Phone: +46186116440, Email: ingrid.jonson.ring@lul.se Ingrid Jönson Ring M Jönson Ring, DDS, MSc, Principal Investigator
Additional Information
Related publications: Bower WF, Moore KH, Shepherd RB, Adams RD. The epidemiology of childhood enuresis in Australia. Br J Urol. 1996 Oct;78(4):602-6. Nevéus 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. Review. Timms DJ. Rapid maxillary expansion in the treatment of nocturnal enuresis. Angle Orthod. 1990 Fall;60(3):229-33; discussion 234. Kurol J, Modin H, Bjerkhoel A. Orthodontic maxillary expansion and its effect on nocturnal enuresis. Angle Orthod. 1998 Jun;68(3):225-32. Usumez S, Işeri H, Orhan M, Basciftci FA. Effect of rapid maxillary expansion on nocturnal enuresis. Angle Orthod. 2003 Oct;73(5):532-8. Schütz-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.
Starting date: January 2014
Last updated: May 26, 2015
|