Nocturnal Enuresis Clinical Trial
Official title:
The Effect of Melatonin on Nocturnal Enuresis
Aim: To investigate the effect of melatonin in bedwetting.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | August 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years to 14 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Center of Child Incontinence, Pediatric department, Aarhus Universityhospital | Aarhus | Region Midtjylland |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | number of incontinence episodes | 10 weeks | No | |
Secondary | nocturnal blood pressure | Time frame: Week 1: Baseline. Week 5: Effect of 1st treatment arm. Week 6: Wash out. Week 10: Effect of 2nd treatment arm. |
4 weeks | No |
Secondary | activity level | Time frame: Week 1: Baseline. Week 5: Effect of 1st treatment arm. Week 6: Wash out. Week 10: Effect of 2nd treatment arm. |
4 weeks | No |
Secondary | bladder capacity | Time frame: Week 1: Baseline. Week 5: Effect of 1st treatment arm. Week 6: Wash out. Week 10: Effect of 2nd treatment arm. |
4 weeks | No |
Secondary | nocturnal urine production | Time frame: Week 1: Baseline. Week 5: Effect of 1st treatment arm. Week 6: Wash out. Week 10: Effect of 2nd treatment arm. |
4 weeks | No |
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