A New Check-list Method for Nocturnal Enuresis

NCT03510975 | Completed Phase 4 DMC

• 1 other identifier: 014
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Nocturnal Enuresis

Keywords

behavioural therapy; mono symptomatic nocturnal enuresis; compliance; response

Outcome Measures

Primary Outcomes (1)

• dry nights

  dry nights were checked by daily voiding diary

  8 weeks

Study Arms (3)

Verbal Behavioral Therapy

SHAM COMPARATOR

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

Behavioral: Verbal behavioral therapy

Check-list

EXPERIMENTAL

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

Behavioral: Behavioral therapy with written check-list

Desmopressin plus verbal therapy

ACTIVE COMPARATOR

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

Drug: desmopressin melt form 120 μg; Behavioral: Verbal behavioral therapy

Interventions

desmopressin melt form 120 μg DRUG

desmopressin melt form 120 μg (Minirin, Ferring International center, Switzerland) once daily before going to bed

Desmopressin plus verbal therapy

Verbal behavioral therapy BEHAVIORAL

Verbal behavioral therapy includes reward system, restriction excessive fluid intake, lifting and waking after sleep to urinate, keeping daily voiding diary

Desmopressin plus verbal therapy; Verbal Behavioral Therapy

Behavioral therapy with written check-list BEHAVIORAL

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

Check-list

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara Training and Research Hospital: lead

Study Sites (1)

Ankara Training and Research Hospital

Ankara, 06340, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 23881652 RESULT

• 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.

  PMID: 28888814 RESULT

MeSH Terms

Conditions

Nocturnal Enuresis; Patient Compliance

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Enuresis; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ahmet M Hascicek, M.D.

  Ankara Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Model Details: 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.

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: April 27, 2018
• Study Start: January 1, 2015
• Primary Completion: December 31, 2017
• Study Completion: March 1, 2018
• Last Updated: May 1, 2018

Record last verified: 2018-04

Locations

TU (1)