Clinical Trial: Nocturnal Enuresis and Rapid Maxillary Expansion

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 ac

Detailed Summary:
Sponsor: Uppsala University Hospital

Current Primary Outcome: Number of wet night [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Quality of life [ Time Frame: Baseline, 6 months ]
  Two validated quality of life questionnaires will be used in this study.
• Sleep quality [ Time Frame: Baseline, 1 month, 6 months ]
  Polygraphic sleep recordings will be carried out at 3 time points dying the study

Original Secondary Outcome: Same as current

Information By: Uppsala University Hospital

Dates:
Date Received: June 24, 2014
Date Started: January 2014
Date Completion: November 2018
Last Updated: May 19, 2017
Last Verified: May 2017