The Effect of Melatonin on Nocturnal Enuresis

Study Overview
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Brief Summary
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Aim: To investigate the effect of melatonin in bedwetting.

Detailed Description
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Design: Double blind randomized placebocontrolled trial using crossover.

Official Title
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The Effect of Melatonin on Nocturnal Enuresis

Conditions
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Nocturnal Enuresis

Intervention / Treatment
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* Drug: Melatonin
* Drug: Lactose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Melatonin<br> | Drug: Melatonin<br>* blinded capsule 2-4 mg/day, oral use, for 4 weeks<br>|
| Placebo Comparator: Lactose<br> | Drug: Lactose<br>* blinded capsule 1/day, oral use, for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of incontinence episodes |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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enuresis, melatonin, circadian rhythm, children, blood pressure, urine production, activity, sleep