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A New Check-list Method for Nocturnal Enuresis

Primary Purpose

Nocturnal Enuresis

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
desmopressin melt form 120 μg
Verbal behavioral therapy
Behavioral therapy with written check-list
Sponsored by
Ankara Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nocturnal Enuresis focused on measuring behavioural therapy, mono symptomatic nocturnal enuresis, compliance, response

Eligibility Criteria

6 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • monosymptomatic nocturnal enuresis
  • bed-wetting frequency of 3 or more nights per week for at last 14 days

Exclusion Criteria:

  • active urinary tract infection
  • non-monosymptomatic nocturnal enuresis
  • endocrinologic disease like diabetes mellitus or diabetes insipidus which can cause polyuria
  • presence or history of renal disease
  • hypertension
  • genitourinary abnormality
  • neurological or psychological disease
  • previous medical or alarm therapy for nocturnal enuresis.

Sites / Locations

  • Ankara Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Experimental

Active Comparator

Arm Label

Verbal Behavioral Therapy

Check-list

Desmopressin plus verbal therapy

Arm Description

All children and their parents were instructed only a verbal behavioral therapy

All participants were instructed a behavioral therapy with a written formed check-list for parents to complete

All children in Group III received desmopressin melt form 120 μg (Minirin, Ferring International center, Switzerland) plus verbal behavioral therapy.

Outcomes

Primary Outcome Measures

dry nights
dry nights were checked by daily voiding diary

Secondary Outcome Measures

Full Information

First Posted
April 18, 2018
Last Updated
April 27, 2018
Sponsor
Ankara Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03510975
Brief Title
A New Check-list Method for Nocturnal Enuresis
Official Title
A New Check-list Method Enhances the Treatment Compliance and Response of Simple Behavioral Therapy for Primary Monosymptomatic Nocturnal Enuresis. Prospective Randomised Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
March 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study is aimed to demonstrate the benefits of newly formed written check-list of behavioral instructions and investigate its effects on parent's awareness, consciousness and motivation toward MNE. The parents with children who complain of bed-wetting 3 or more nights per week for at last 14 days, they was randomly divided into three groups. The parents in Group I were instructed only a verbal behavioral therapy, the parents in Group II were instructed a behavioral therapy with a written formed check-list for parents to fulfill and the children in Group III will received desmopressin treatment plus verbal behavioral therapy. All participants were analysed the compliance and response rate of treatment over time period of 8 week.
Detailed Description
Monosymptomatic Nocturnal Enuresis (MNE) is defined as involuntarily nighttime bed-wetting after the age of 5 years without any other lower urinary tract symptoms and without a history of bladder dysfunction. MNE can lead to developmental and psychosocial problems on child and negative impact of the family life. It has been recommended that consisting of collaboration with children and their parents is very crucial point to tackle this disturbing condition. Behavioral therapy can be effective and these should be first-line treatment for MNE on the basis of the attitude of the child and parents. The behavioral therapy is composed of a lot of verbal recommendations including urination before going to sleep at night, a monitorisation daily fluid intake, a restriction of fluid volume before bedtime, rewards for dry nights, etc. However, we have noticed that these instructions have not been documented as a written list yet. We have analysed the literature and composed several recommendations were formed as a written check-list for parents to instruct. In this present study, we aimed to investigate the efficiency of check-list that are newly formed by a number of written behavioral instructions and demonstrate whether this rises awareness, consciousness and motivation of child's parents toward MNE. This study was conducted as a prospective randomized study at the Urology Department, Ankara Training and Research Hospital, Medical Science University, Ankara, Turkey Of ninety six children and their parents, seventy-five were randomly selected from the Urology outpatient clinic complaining of MNE. They were divided into three groups according to the therapy which were defined by the investigators before recruitment. Twenty-five children and their parents were instructed only a verbal behavioral therapy, 25 were instructed a behavioral therapy with a written check-list form and 25 children received desmopressin treatment plus verbal behavioral therapy were randomly included in the study. Each participants in this study was recorded medical history, demographic data including age of children and parents, number of children, educational and economic status of parents, wet nights. Economic status of family was defined by the hunger and the poverty limits from data of Turkish Statistical Institute All children were done detailed physical examination to rule out abnormal physical development, presence of genitourinary or neurological diseases. Urine analysis, serum creatinine, blood urine nitrogen, sodium, potassium, complete blood count, ultrasonography or plain X ray if necessary were measured. The parents in Group I were received verbal behavioral instruction. 25 parents in Group II were instructed to fulfill a check-list that were composed of written instructions during a 8 week period. Also children had to register their wet nights via daily voiding diary. 25 children in Group III were received desmopressin melt form 120 μg (Minirin, Ferring International center, Switzerland) once daily before going to bed for 2 months plus verbal behavioral instructions. Details and instructions about the drug and its use were given to the all children and their parents. All participants were checked every 2 weeks to control compliance rate of behavioral therapy (written or verbal) or medical treatment and analyse the response of the children with daily voiding diary.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturnal Enuresis
Keywords
behavioural therapy, mono symptomatic nocturnal enuresis, compliance, response

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
All participants were divided into three groups. Twenty-five children and their parents were instructed only a verbal behavioral therapy, 25 were instructed a behavioral therapy with a written check-list form and 25 children received desmopressin treatment plus verbal behavioral therapy were randomly included in the study.
Masking
Participant
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Verbal Behavioral Therapy
Arm Type
Sham Comparator
Arm Description
All children and their parents were instructed only a verbal behavioral therapy
Arm Title
Check-list
Arm Type
Experimental
Arm Description
All participants were instructed a behavioral therapy with a written formed check-list for parents to complete
Arm Title
Desmopressin plus verbal therapy
Arm Type
Active Comparator
Arm Description
All children in Group III received desmopressin melt form 120 μg (Minirin, Ferring International center, Switzerland) plus verbal behavioral therapy.
Intervention Type
Drug
Intervention Name(s)
desmopressin melt form 120 μg
Intervention Description
desmopressin melt form 120 μg (Minirin, Ferring International center, Switzerland) once daily before going to bed
Intervention Type
Behavioral
Intervention Name(s)
Verbal behavioral therapy
Intervention Description
Verbal behavioral therapy includes reward system, restriction excessive fluid intake, lifting and waking after sleep to urinate, keeping daily voiding diary
Intervention Type
Behavioral
Intervention Name(s)
Behavioral therapy with written check-list
Intervention Description
Behavioral therapy with written check-list includes reward system, restriction excessive fluid intake, lifting and waking after sleep to urinate, keeping daily voiding diary, ensuring optimal posture to facilitate good bladder function and bowel movements, avoding holding urine, encouring healthy diet
Primary Outcome Measure Information:
Title
dry nights
Description
dry nights were checked by daily voiding diary
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: monosymptomatic nocturnal enuresis bed-wetting frequency of 3 or more nights per week for at last 14 days Exclusion Criteria: active urinary tract infection non-monosymptomatic nocturnal enuresis endocrinologic disease like diabetes mellitus or diabetes insipidus which can cause polyuria presence or history of renal disease hypertension genitourinary abnormality neurological or psychological disease previous medical or alarm therapy for nocturnal enuresis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmet M Hascicek, M.D.
Organizational Affiliation
Ankara Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara Training and Research Hospital
City
Ankara
ZIP/Postal Code
06340
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23881652
Citation
Caldwell PH, Nankivell G, Sureshkumar P. Simple behavioural interventions for nocturnal enuresis in children. Cochrane Database Syst Rev. 2013 Jul 19;(7):CD003637. doi: 10.1002/14651858.CD003637.pub3.
Results Reference
result
PubMed Identifier
28888814
Citation
Haid B, Tekgul S. Primary and Secondary Enuresis: Pathophysiology, Diagnosis, and Treatment. Eur Urol Focus. 2017 Apr;3(2-3):198-206. doi: 10.1016/j.euf.2017.08.010. Epub 2017 Sep 6.
Results Reference
result

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A New Check-list Method for Nocturnal Enuresis

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