Nocturnal Enuresis and Rapid Maxillary Expansion

Nocturnal Enuresis Clinical Trial

— NERME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02178826
• Other study ID #: LUL-2012/379
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: March 2019

Study information

• Verified date: March 2020
• Source: Uppsala University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 14 Years

Eligibility

Inclusion Criteria:

• Patients aged 7-14 years old

• At least 7 wet nights out of 14

Exclusion Criteria:

• Daytime incontinence

• Constipation

• ADHD

Related Conditions & MeSH terms

• Enuresis
• Nocturnal Enuresis
• Urinary Incontinence

Intervention

Device:
• Rapid Maxillary Expansion
The Rapid Maxillary Expander will over 10-14 days create a palatal expansion of about 5mm.
• Placebo Appliance
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.

Locations

Country	Name	City	State
Sweden	Folktandvården Uppsala län	Uppsala	Uppland

Sponsors (3)

Lead Sponsor	Collaborator
Uppsala University Hospital	Örebro County Council, Uppsala County Council, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (6)

Bower WF, Moore KH, Shepherd RB, Adams RD. The epidemiology of childhood enuresis in Australia. Br J Urol. 1996 Oct;78(4):602-6. — View Citation

Kurol J, Modin H, Bjerkhoel A. Orthodontic maxillary expansion and its effect on nocturnal enuresis. Angle Orthod. 1998 Jun;68(3):225-32. — View Citation

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. — View Citation

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. — View Citation

Timms DJ. Rapid maxillary expansion in the treatment of nocturnal enuresis. Angle Orthod. 1990 Fall;60(3):229-33; discussion 234. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enuresis frequency	Number of wet night	6 months
Secondary	QoL	The validated quality of life questionnaire Paediatric Incontinence Questionnaire	Baseline, 6 months
Secondary	QoL	The validated quality of life questionnaire OSA 18	Baseline, 1 month, 6 months
Secondary	Sleep quality	Polygraphic sleep recordings will be carried out at 3 time points during the study	Baseline, 1 month, 6 months