NCT02178826

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 1, 2014

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

5 years

First QC Date

June 24, 2014

Last Update Submit

March 30, 2020

Conditions

Nocturnal Enuresis

Keywords

Nocturnal EnuresisRapid Maxillary ExpansionOrthodonticsPolysomnographyQuality of life

Outcome Measures

Primary Outcomes (1)

  • Enuresis frequency

    Number of wet night

    6 months

Secondary Outcomes (3)

  • QoL

    Baseline, 6 months

  • QoL

    Baseline, 1 month, 6 months

  • Sleep quality

    Baseline, 1 month, 6 months

Study Arms (2)

Rapid Maxillary Expansion

EXPERIMENTAL

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

Device: Rapid Maxillary Expansion

Placebo group

PLACEBO COMPARATOR

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

Interventions

Rapid Maxillary ExpansionDEVICE

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

Also known as: Hyrax screw
Rapid Maxillary Expansion
Placebo ApplianceDEVICE

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.

Also known as: Sham Device
Placebo group

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Daytime incontinence
  • Constipation
  • ADHD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Folktandvården Uppsala län

Uppsala, Uppland, 75322, Sweden

Location

Related 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. doi: 10.1046/j.1464-410x.1996.13618.x.

    PMID: 8944518BACKGROUND

  • 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.

    PMID: 21267599BACKGROUND

  • 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.

    PMID: 2202238BACKGROUND

  • 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.

    PMID: 9622759BACKGROUND

  • 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.

    PMID: 14580020BACKGROUND

  • 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.

    PMID: 18251602BACKGROUND

MeSH Terms

Conditions

Nocturnal Enuresis

Condition Hierarchy (Ancestors)

EnuresisUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBehavioral SymptomsBehaviorElimination DisordersMental Disorders

Study Officials

  • Ingrid M Jönson Ring, DDS, MSc

    Uppsala University Hospital

    PRINCIPAL INVESTIGATOR

  • Farhan Bazargani, DDS, PhD

    Örebro County Council

    STUDY DIRECTOR

  • Tryggve Nevéus, MD, PhD

    Uppsala University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Rapid Maxillary Expansion
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 24, 2014

First Posted

July 1, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2019

Study Completion

March 1, 2019

Last Updated

March 31, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)