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Nocturnal Enuresis and Rapid Maxillary Expansion (NERME)

Primary Purpose

Nocturnal Enuresis

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Rapid Maxillary Expansion
Placebo Appliance
Sponsored by
Uppsala University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nocturnal Enuresis focused on measuring Nocturnal Enuresis, Rapid Maxillary Expansion, Orthodontics, Polysomnography, Quality of life

Eligibility Criteria

7 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Daytime incontinence
  • Constipation
  • ADHD

Sites / Locations

  • Folktandvården Uppsala län

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rapid Maxillary Expansion

Placebo group

Arm Description

A Rapid Maxillary Expander will be fitted and the palate will be expanded approximately 5mm.

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.

Outcomes

Primary Outcome Measures

Enuresis frequency
Number of wet night

Secondary Outcome Measures

QoL
The validated quality of life questionnaire Paediatric Incontinence Questionnaire
QoL
The validated quality of life questionnaire OSA 18
Sleep quality
Polygraphic sleep recordings will be carried out at 3 time points during the study

Full Information

First Posted
June 24, 2014
Last Updated
March 30, 2020
Sponsor
Uppsala University Hospital
Collaborators
Örebro County Council, Uppsala County Council, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT02178826
Brief Title
Nocturnal Enuresis and Rapid Maxillary Expansion
Acronym
NERME
Official Title
Nocturnal Enuresis and Rapid Maxillary Expansion - Long Term Effect, Prognostic Factors, Quality of Life and Sleep Quality
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University Hospital
Collaborators
Örebro County Council, Uppsala County Council, Sweden

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturnal Enuresis
Keywords
Nocturnal Enuresis, Rapid Maxillary Expansion, Orthodontics, Polysomnography, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Rapid Maxillary Expansion
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rapid Maxillary Expansion
Arm Type
Experimental
Arm Description
A Rapid Maxillary Expander will be fitted and the palate will be expanded approximately 5mm.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Rapid Maxillary Expansion
Other Intervention Name(s)
Hyrax screw
Intervention Description
The Rapid Maxillary Expander will over 10-14 days create a palatal expansion of about 5mm.
Intervention Type
Device
Intervention Name(s)
Placebo Appliance
Other Intervention Name(s)
Sham Device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Enuresis frequency
Description
Number of wet night
Time Frame
6 months
Secondary Outcome Measure Information:
Title
QoL
Description
The validated quality of life questionnaire Paediatric Incontinence Questionnaire
Time Frame
Baseline, 6 months
Title
QoL
Description
The validated quality of life questionnaire OSA 18
Time Frame
Baseline, 1 month, 6 months
Title
Sleep quality
Description
Polygraphic sleep recordings will be carried out at 3 time points during the study
Time Frame
Baseline, 1 month, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 7-14 years old At least 7 wet nights out of 14 Exclusion Criteria: Daytime incontinence Constipation ADHD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingrid M Jönson Ring, DDS, MSc
Organizational Affiliation
Uppsala University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Farhan Bazargani, DDS, PhD
Organizational Affiliation
Örebro County Council
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tryggve Nevéus, MD, PhD
Organizational Affiliation
Uppsala University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Folktandvården Uppsala län
City
Uppsala
State/Province
Uppland
ZIP/Postal Code
75322
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
8944518
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.
Results Reference
background
PubMed Identifier
21267599
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.
Results Reference
background
PubMed Identifier
2202238
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.
Results Reference
background
PubMed Identifier
9622759
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.
Results Reference
background
PubMed Identifier
14580020
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.
Results Reference
background
PubMed Identifier
18251602
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.
Results Reference
background

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Nocturnal Enuresis and Rapid Maxillary Expansion

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