Skip to main content
OpenTrials
Completed

NCT Number: NCT02178826

Nocturnal Enuresis and Rapid Maxillary Expansion

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

7 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Folktandvården Uppsala län

Uppsala, Uppland, 75322, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Daytime incontinence
  • Constipation
  • ADHD

Treatment and study plan

Rapid Maxillary Expansion

Device

The Rapid Maxillary Expander will over 10-14 days create a palatal expansion of about 5mm.

Other names: Hyrax screw

Placebo Appliance

Device

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.

Other names: Sham Device

Primary outcomes

  1. Enuresis frequency

    Time frame: 6 months

    Number of wet night

Secondary outcomes

  1. QoL

    Time frame: Baseline, 6 months

    The validated quality of life questionnaire Paediatric Incontinence Questionnaire

  2. QoL

    Time frame: Baseline, 1 month, 6 months

    The validated quality of life questionnaire OSA 18

  3. Sleep quality

    Time frame: Baseline, 1 month, 6 months

    Polygraphic sleep recordings will be carried out at 3 time points during the study

Sponsors and collaborators

Lead sponsor

Uppsala University Hospital

Other

Collaborators

  • Uppsala County Council, Sweden
  • Örebro County Council

Registry information

Official study title

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

Acronym: NERME

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jul 1, 2014
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.