Nocturnal Enuresis
Conditions
Keywords
enuresis, melatonin, circadian rhythm, children, blood pressure, urine production, activity, sleep
Brief summary
Aim: To investigate the effect of melatonin in bedwetting.
Detailed description
Design: Double blind randomized placebocontrolled trial using crossover.
Interventions
DRUGMelatonin
blinded capsule 2-4 mg/day, oral use, for 4 weeks
DRUGLactose
blinded capsule 1/day, oral use, for 4 weeks
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Monosymptomatic nocturnal enuresis * Age 6-14 years * Clinical examination normal * ≥ 3 wet nights / week due to either nocturnal polyuria with normal bladder size or reduced functional bladder capacity with normal urine output
Exclusion criteria
* Constipation (by ROME III criteria) * Day incontinence * Overactive bladder (ICCS 2008 classification of symptoms) * Current or past history of clinical or laboratory findings that can be related to diseases or - conditions (eg pregnancy) likely to change the parameters examined, especially diseases of the kidney and urinary tract, liver or endocrine disorder. * Clinical signs of urinary tract infection * Hypertension, blood pressure assessed by ambulatory measurement with blood pressure cuff * Set treatment with one or more drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of incontinence episodes | 10 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| nocturnal blood pressure | 4 weeks | Time frame: Week 1: Baseline. Week 5: Effect of 1st treatment arm. Week 6: Wash out. Week 10: Effect of 2nd treatment arm. |
| activity level | 4 weeks | Time frame: Week 1: Baseline. Week 5: Effect of 1st treatment arm. Week 6: Wash out. Week 10: Effect of 2nd treatment arm. |
| bladder capacity | 4 weeks | Time frame: Week 1: Baseline. Week 5: Effect of 1st treatment arm. Week 6: Wash out. Week 10: Effect of 2nd treatment arm. |
| nocturnal urine production | 4 weeks | Time frame: Week 1: Baseline. Week 5: Effect of 1st treatment arm. Week 6: Wash out. Week 10: Effect of 2nd treatment arm. |
Countries
Denmark
Contacts
Primary ContactSøren Rittig, MD, dr.med, professor
Backup ContactBritt Borg, MS
Outcome results
None listed