Study Stopped
Unable to sufficiently enroll or collect follow-up
Intranasal Steroids for the Treatment of Nocturnal Enuresis With Associated Obstructive Sleep Apnea
1 other identifier
interventional
N/A
1 country
2
Brief Summary
Enuresis (E) or bedwetting is a common pediatric complaint, and recent research has discovered a link with obstructive sleep apnea (OSA). In children, OSA is often secondary to enlargement of their adenoids or tonsils, and is often successfully treated with a steroid solution given through the nose. The relationship between SDB and E is incompletely understood. Airway obstruction affects the quality of sleep, as the child will wake as the oxygen levels drop. Abnormal sleep also can decrease the secretion of hormones that affects the kidney's ability to concentrate urine at night, which can result in too much urine in the bladder. Contemporary evidence also suggests that patients with enuresis have abnormal sleep phases, which may impair the communications and inhibition of the bladder. In previous studies, the investigators have demonstrated that children with E have a high likelihood of having concomitant SDB. The investigators have also demonstrated that children with E and symptoms of SDB do not respond to typical management for bedwetting. Therefore, the investigators propose to treat patients presenting with E with our standard treatments for E (bed alarm) and first line therapy for SDB: Intranasal steroids. This medication helps to decrease the inflammation of the adenoids and tonsils, thereby reducing the airway obstruction. the investigators hypothesize that children with significant symptoms of SDB will improve with the addition of INS, and the investigators hope to see an improvement in their bedwetting, quality of life, and sleep quality as well. To test this, patents with E will be recruited from the pediatric urology clinic. They will be offered the standard treatment for E, the bed alarm, and the treatment group will be given an intranasal steroid spray. The investigators will then reassess the patients 3 months after treatment, and compare the two groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2013
Typical duration for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 21, 2013
CompletedFirst Posted
Study publicly available on registry
May 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedDecember 18, 2015
December 1, 2015
2.6 years
May 21, 2013
December 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Degree of improvement in enuresis after a 3 month trial of INS + bed alarm, compared to the bed alarm alone.
3 months
Secondary Outcomes (3)
Changes in OSA-18 and PSQ-22 scores after 3 month trial of INS
3 months
Adverse effects related to treatments
3 months
Patient related differences ie obesity, age, sex, and the effect on continence/treatment
3 months
Study Arms (2)
Bed Alarm
ACTIVE COMPARATORPatients in the control arm will use only the bed alarm for treatment of their enuresis
Bed alarm + intranasal steroids
EXPERIMENTALIntervention: Nasonex (Mometasone furoate aqueous nasal spray) Children 5-11: 50 mcg/metered spray, 1 sprays in each nostril daily for 3 months in conjunction with nightly use of the bed alarm. Children ≥ 12: 50 mcg/metered spray, 2 sprays in each nostril daily for 3 months in conjunction with nightly use of the bed alarm.
Interventions
The bed alarm is a device that is worn at night with a sensor in the child's underwear. The alarm will activate when the child urinates, helping the brain to link the sensation of a full bladder with wakening.
Intranasal steroids are used by otolaryngologists as first line treatment for adenotonsillar hypertrophy in children with suspected sleep-disordered breathing and obstructive sleep apnea. The spray helps to shrink the size of the adenoids and tonsils, diminishing the amount of tissue obstructing the child's airway.
Eligibility Criteria
You may qualify if:
- Ages between 5-17
- endorse 5/6 questions on the PSQ-22. These questions include: While sleeping, does your child: Ever snore? Snore more than half the time? Always snore? Snore loudly? Have "heavy" or loud breathing? Have trouble breathing, or struggle to breath?
- desire to use the bed alarm
You may not qualify if:
- Children \<5
- known neurological disorders resulting in neuropathic bowel or bladder disorder including, but not limited to spinal dysraphisms and spinal cord injuries.
- significant congenital bladder anomalies, such as bladder exstrophy or posterior urethral valves
- patients with craniofacial anomalies or syndromes known to be associated with obstructive sleep apnea (i.e. Trisomy 21, muccopolysaccardiosis)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Stollery Children's Hospital
Edmonton, Alberta, T6G 2B7, Canada
Synergy Respiratory Care Centre
Sherwood Park, Alberta, T8H 0N2, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Metcalfe, MD
Stollery Children's Hospital and the University of Alberta
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Urologist
Study Record Dates
First Submitted
May 21, 2013
First Posted
May 23, 2013
Study Start
May 1, 2013
Primary Completion
December 1, 2015
Study Completion
June 1, 2016
Last Updated
December 18, 2015
Record last verified: 2015-12