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The Effect of Melatonin on Nocturnal Enuresis

Primary Purpose

Nocturnal Enuresis

Status
Unknown status
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Melatonin
Lactose
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nocturnal Enuresis focused on measuring enuresis, melatonin, circadian rhythm, children, blood pressure, urine production, activity, sleep

Eligibility Criteria

6 Years - 14 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Center of Child Incontinence, Pediatric department, Aarhus UniversityhospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Melatonin

Lactose

Arm Description

Outcomes

Primary Outcome Measures

number of incontinence episodes

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
February 24, 2012
Last Updated
November 1, 2012
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT01575678
Brief Title
The Effect of Melatonin on Nocturnal Enuresis
Official Title
The Effect of Melatonin on Nocturnal Enuresis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
August 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Aim: To investigate the effect of melatonin in bedwetting.
Detailed Description
Design: Double blind randomized placebocontrolled trial using crossover.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturnal Enuresis
Keywords
enuresis, melatonin, circadian rhythm, children, blood pressure, urine production, activity, sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Melatonin
Arm Type
Active Comparator
Arm Title
Lactose
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Melatonin
Intervention Description
blinded capsule 2-4 mg/day, oral use, for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Lactose
Intervention Description
blinded capsule 1/day, oral use, for 4 weeks
Primary Outcome Measure Information:
Title
number of incontinence episodes
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
nocturnal blood pressure
Description
Time frame: Week 1: Baseline. Week 5: Effect of 1st treatment arm. Week 6: Wash out. Week 10: Effect of 2nd treatment arm.
Time Frame
4 weeks
Title
activity level
Description
Time frame: Week 1: Baseline. Week 5: Effect of 1st treatment arm. Week 6: Wash out. Week 10: Effect of 2nd treatment arm.
Time Frame
4 weeks
Title
bladder capacity
Description
Time frame: Week 1: Baseline. Week 5: Effect of 1st treatment arm. Week 6: Wash out. Week 10: Effect of 2nd treatment arm.
Time Frame
4 weeks
Title
nocturnal urine production
Description
Time frame: Week 1: Baseline. Week 5: Effect of 1st treatment arm. Week 6: Wash out. Week 10: Effect of 2nd treatment arm.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Søren Rittig, MD, dr.med, professor
Email
rittig@ki.au.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Britt Borg, MS
Phone
+4578451523
Email
bborg@ki.au.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Søren Rittig, MD, dr.med
Organizational Affiliation
Pediatric department, Aarhus Universityhospital, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center of Child Incontinence, Pediatric department, Aarhus Universityhospital
City
Aarhus
State/Province
Region Midtjylland
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Britt Borg, postgrad. medical student
Phone
+45 78451523
Email
bborg@ki.au.dk
First Name & Middle Initial & Last Name & Degree
Kostas Kamperis, MD, Ph.D
First Name & Middle Initial & Last Name & Degree
Birgitte Mahler, MD, Ph.D
First Name & Middle Initial & Last Name & Degree
Britt Borg, postgrad. medical student

12. IPD Sharing Statement

Citations:
PubMed Identifier
32364251
Citation
Caldwell PH, Codarini M, Stewart F, Hahn D, Sureshkumar P. Alarm interventions for nocturnal enuresis in children. Cochrane Database Syst Rev. 2020 May 4;5(5):CD002911. doi: 10.1002/14651858.CD002911.pub3.
Results Reference
derived

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The Effect of Melatonin on Nocturnal Enuresis

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