The Effect of Melatonin on Nocturnal Enuresis

University of Aarhus

Status and phase: Unknown; Phase 2

Conditions: Nocturnal Enuresis

Treatments: Drug: Melatonin; Drug: Lactose

Study type: Interventional

Funder types: Other

Identifiers

NCT01575678

EnuMel-11

2011-004138-33 (EudraCT Number)

Details and patient eligibility

About

Aim: To investigate the effect of melatonin in bedwetting.

Full description

Design: Double blind randomized placebocontrolled trial using crossover.

Enrollment: 40 estimated patients

Sex: All

Ages: 6 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Melatonin

Active Comparator group

Treatment:

Drug: Melatonin

Lactose

Placebo Comparator group

Treatment:

Drug: Lactose