A New Check-list Method for Nocturnal Enuresis

A

Ankara Training and Research Hospital

Status and phase

Completed
Phase 4

Conditions

Nocturnal Enuresis

Treatments

Behavioral: Behavioral therapy with written check-list
Drug: desmopressin melt form 120 μg
Behavioral: Verbal behavioral therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03510975
014

Details and patient eligibility

About

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.

Full 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.

Enrollment

75 patients

Sex

All

Ages

6 to 15 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

75 participants in 3 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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