The Effect of Melatonin on Nocturnal Enuresis

Phase 2

• Conditions: Nocturnal Enuresis
• Interventions: Drug: Melatonin; Drug: Lactose

• Registration Number: NCT01575678
• Lead Sponsor: University of Aarhus

Brief Summary

Aim: To investigate the effect of melatonin in bedwetting.

Detailed Description

Design: Double blind randomized placebocontrolled trial using crossover.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-02-24
• Study First Submitted QC: 2012-04-10
• Study First Posted: 2012-04-11
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-01
• Last Update Posted: 2012-11-02
• Primary Completion: 2013-08
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Melatonin	Melatonin	-
Lactose	Lactose	-

Primary Outcome Measures

Name	Time	Method
number of incontinence episodes	10 weeks

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Center of Child Incontinence, Pediatric department, Aarhus Universityhospital; 🇩🇰 Aarhus, Region Midtjylland, Denmark