The Effect of Melatonin on Nocturnal Enuresis

• Sponsor: University of Aarhus (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01575678
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 19
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

Aim: To investigate the effect of melatonin in bedwetting.

Condition or Disease	Intervention/Treatment	Phase
Nocturnal Enuresis	Drug: Melatonin; Drug: Lactose	Phase 2

Detailed Description

Design: Double blind randomized placebocontrolled trial using crossover.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effect of Melatonin on Nocturnal Enuresis
• Study Start Date: Jan 1, 2012
• Anticipated Primary Completion Date: Aug 1, 2013
• Anticipated Study Completion Date: Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Melatonin	Drug: Melatonin; blinded capsule 2-4 mg/day, oral use, for 4 weeks
Placebo Comparator: Lactose	Drug: Lactose; blinded capsule 1/day, oral use, for 4 weeks

Outcome Measures

Primary Outcome Measures

1. number of incontinence episodes [10 weeks]

Secondary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 14 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center of Child Incontinence, Pediatric department, Aarhus Universityhospital	Aarhus	Region Midtjylland	Denmark	8200

Sponsors and Collaborators

• University of Aarhus

Investigators

• Principal Investigator: Søren Rittig, MD, dr.med, Pediatric department, Aarhus Universityhospital, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT01575678
• Other Study ID Numbers: EnuMel-11; 2011-004138-33
• First Posted: Apr 11, 2012
• Last Update Posted: Nov 2, 2012
• Last Verified: Nov 1, 2012

• Keywords provided by University of Aarhus: enuresis; melatonin; circadian rhythm; children; blood pressure; urine production; activity; sleep
• Additional relevant MeSH terms: Enuresis; Urinary Incontinence; Nocturnal Enuresis; Melatonin

Study Results

No Results Posted as of Nov 2, 2012