Nocturnal EnuresisNERMENCT02178826
Nocturnal Enuresis and Rapid Maxillary Expansion
A study testing Rapid Maxillary Expansion in people with Nocturnal Enuresis, run by Uppsala University Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Nocturnal Enuresis
- What is being tested?
- Rapid Maxillary Expansion
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2014to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged 7-14 years old
- At least 7 wet nights out of 14
Who cannot join
- Daytime incontinence
- Constipation
- ADHD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
NE is a multifactorial condition. Three central factors have been identified:
- Many bedwetting children produce large amounts of urine at night due to a deficiency of the antidiuretic hormone vasopressin.
- 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.
- Conditions
- Nocturnal Enuresis
- Being tested
- Rapid Maxillary Expansion, Placebo Appliance
- Keywords
- Nocturnal Enuresis, Rapid Maxillary Expansion, Orthodontics, Polysomnography, Quality of life
- Medical subject headings
- Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Maxillary ExpansionDevice
Also called Hyrax screw
The Rapid Maxillary Expander will over 10-14 days create a palatal expansion of about 5mm.
Placebo ApplianceDevice
Also called Sham 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.
| Study group | Role | What they receive |
|---|---|---|
| Rapid Maxillary Expansion | Experimental | A Rapid Maxillary Expander will be fitted and the palate will be expanded approximately 5mm. Receives: 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. Receives: Device: Placebo Appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enuresis frequency
Number of wet night
Measured: 6 months
Secondary outcomes (3)
QoL
The validated quality of life questionnaire Paediatric Incontinence Questionnaire
Measured: Baseline, 6 months
QoL
The validated quality of life questionnaire OSA 18
Measured: Baseline, 1 month, 6 months
Sleep quality
Polygraphic sleep recordings will be carried out at 3 time points during the study
Measured: Baseline, 1 month, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Nocturnal EnuresisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Rapid Maxillary Expansion
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Örebro County Council, Uppsala County Council, Sweden
- Responsible party
- Principal investigator, Ingrid Jönson Ring, Uppsala University Hospital
- Investigators
- Ingrid M Jönson Ring, DDS, MSc, Principal investigator, Uppsala University HospitalFarhan Bazargani, DDS, PhD, Study director, Örebro County CouncilTryggve Nevéus, MD, PhD, Study chair, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178826
- Sponsor's protocol ID
- LUL-2012/379
- Acronym
- NERME
- Status last verified
- Mar 2020
- First submitted
- 24 Jun 2014
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 8944518Neveus 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.
PubMed 21267599Timms 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.
PubMed 2202238Kurol 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.
PubMed 9622759Usumez 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.
PubMed 14580020Schutz-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.
PubMed 18251602
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nocturnal Enuresis and Rapid Maxillary Expansion - Long Term Effect, Prognostic Factors, Quality of Life and Sleep Quality
- ClinicalTrials.gov ID
- NCT02178826
- Acronym / sponsor ID
- NERME / LUL-2012/379
- Conditions
- Nocturnal Enuresis
- Keywords
- Nocturnal Enuresis, Rapid Maxillary Expansion, Orthodontics, Polysomnography, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Collaborators
- Örebro County Council, Uppsala County Council, Sweden
- Study start
- Jan 2014
- Primary completion
- Jan 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 1 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Many bedwetting children produce large amounts of urine at night due to a deficiency of the antidiuretic hormone vasopressin.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Rapid Maxillary Expansion
| Arm | Type | Receives |
|---|---|---|
| Rapid Maxillary Expansion | Experimental | Device: Rapid Maxillary ExpansionA Rapid Maxillary Expander will be fitted and the palate will be expanded approximately 5mm. |
| Placebo group | Placebo comparator | Device: Placebo ApplianceA 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. |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients aged 7-14 years old
- At least 7 wet nights out of 14
Key exclusion criteria (3 listed)
- Daytime incontinence
- Constipation
- ADHD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid Maxillary ExpansionAlso: Hyrax screwThe Rapid Maxillary Expander will over 10-14 days create a palatal expansion of about 5mm. | Device | Rapid Maxillary Expansion |
| Placebo ApplianceAlso: Sham DeviceThe 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. | Device | Placebo group |
Primary outcome
Enuresis frequency
Time frame: 6 months
Number of wet night
3 secondary outcomes
QoL
Time frame: Baseline, 6 months
QoL
Time frame: Baseline, 1 month, 6 months
Sleep quality
Time frame: Baseline, 1 month, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Background: PubMed 8944518Bower 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.
- Background: PubMed 21267599Neveus 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.
- Background: PubMed 2202238Timms 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.
- Background: PubMed 9622759Kurol 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.
- Background: PubMed 14580020Usumez 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.
- Background: PubMed 18251602Schutz-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingrid M Jönson Ring, DDS, MSc principal investigator
Uppsala University Hospital
Farhan Bazargani, DDS, PhD study director
Örebro County Council
Tryggve Nevéus, MD, PhD study chair
Uppsala University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid Maxillary Expansion in people with Nocturnal Enuresis, run by Uppsala University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enuresis frequency (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02178826, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.