Nocturnal Enuresis and Rapid Maxillary Expansion (NERME)

March 30, 2020 updated by: Ingrid Jönson Ring, Uppsala University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Uppland
      • Uppsala, Uppland, Sweden, 75322
        • Folktandvården Uppsala län

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Daytime incontinence
  • Constipation
  • ADHD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rapid Maxillary Expansion
A Rapid Maxillary Expander will be fitted and the palate will be expanded approximately 5mm.
Device: Rapid Maxillary Expansion
The Rapid Maxillary Expander will over 10-14 days create a palatal expansion of about 5mm.
Other Names:
  • Hyrax screw
Placebo Comparator: Placebo group
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
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University Hospital

Collaborators

Örebro County Council
Uppsala County Council, Sweden

Investigators

  • Principal Investigator: Ingrid M Jönson Ring, DDS, MSc, Uppsala University Hospital
  • Study Director: Farhan Bazargani, DDS, PhD, Örebro County Council
  • Study Chair: Tryggve Nevéus, MD, PhD, Uppsala University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

June 24, 2014

First Submitted That Met QC Criteria

June 30, 2014

First Posted (Estimate)

July 1, 2014

Study Record Updates

Last Update Posted (Actual)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 30, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUL-2012/379

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Nocturnal Enuresis

Clinical Trials on Rapid Maxillary Expansion

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe