A New Check-list Method for Nocturnal Enuresis

NCTNCT03510975Other id014

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 75 participants (actual)
Sponsor: Ankara Training and Research Hospital · Other
Design: Randomized · Single masking
Countries: 1 country
Turkey (Türkiye)
Start: 1 Jan 2015
Primary completion: 31 Dec 2017
Completion: 1 Mar 2018
First posted: 27 Apr 2018
Last update posted: 1 May 2018
Conditions: Nocturnal Enuresis

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20152016201720182019

Ph 4
A New Check-list Method for Nocturnal Enuresis
NCT03510975
1 Jan 2015 to 1 Mar 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

desmopressin melt form 120 μgDrug
Verbal behavioral therapyBehavioral
Behavioral therapy with written check-listBehavioral

Arms3

Sham comparator
Verbal Behavioral Therapy
All children and their parents were instructed only a verbal behavioral therapy
Experimental
Check-list
All participants were instructed a behavioral therapy with a written formed check-list for parents to complete
Active comparator
Desmopressin plus verbal therapy
All children in Group III received desmopressin melt form 120 μg (Minirin, Ferring International center, Switzerland) plus verbal behavioral therapy.

Primary outcomes1

Outcomes the sponsor listed as primary.

dry nights
Time frame · 8 weeks
Registry description
dry nights were checked by daily voiding diary

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

ResultCaldwell PH, Nankivell G, Sureshkumar P. Simple behavioural interventions for nocturnal enuresis in children. Cochrane Database Syst Rev. 2013 Jul 19;2013(7):CD003637. doi: 10.1002/14651858.CD003637.pub3. PMID 23881652
ResultHaid 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

Eligibility

Who could join, as posted.

Sex: All
Age: from 6 Years up to 15 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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.

PepBank is a research reference. Talk to a doctor before you use any peptide.