Condition category
Signs and Symptoms
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
Enuresis (bedwetting) can cause innumerable problems for the child and his parents and affects about 10% of the seven-year-old children. The lack of understanding of the parents about their children’s bedwetting has punishment as one of the results. The aim of this study is to find out the how good the psychological method given to the parents during the treatment of the child with bedwetting is. Along with this we aim to define the profile of the family of such children, to identify the perception of family support and to describe the frequency of punishment practiced by the parents in the study group compared with the control group.

Who can participate?
60 bedwetting children aged between 6 and 18 years can participate in this study.

What does the study involve?
Participants will be randomly allocated to one of two groups: study group and the control group. Parents in the study group will receive psychological counselling and children will receive treatment in an environment that has toys and playful materials. Parents and children belonging to the control group receive treatment as usual.

What are the possible benefits and risks of participating?
There may be improvement in bedwetting, reduction in punishment frequency and improvement in behaviour problems.There are no risks of participating in the study and all children who are not included in the study, received other types of treatment, offered to all children who seek care in the outpatient uropediatria HU-CAS/UFJF.

Where is the study run from?
The University Hospital of the Federal University of Juiz de Fora (Hospital Universitário da Universidade Federal de Juiz De For a), Brazil.

When is the study starting and how long is it expected to run for?
The study will start in December 2015 and will run for one year.

Who is funding the study?
The study is funded by the investigator.

Who is the main contact?
Mr Cacilda Andrade de Sá

Trial website

Contact information



Primary contact

Mr Cacilda Andrade de Sá


Contact details

Rua: Coronel Severiano de Resende
Santos Dumont

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Efficacy of working with parents to reduce punishment frequency of children with enuresis: a randomized, blinded trial


Study hypothesis

Punishment reduction in children, with monosymptomatic enuresis, who presented to psychological service with their family, compared with the control group, where the family did not receive the service.

Ethics approval

Committee on Ethics in Human Research - UFJF (CEP-UFJF): 075-420-2011 FR:432875 CAAF:0050.0.420.000-11

Study design

Randomized blinded interventional trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet




The participants are randomised to two groups:
1. Intervention group:
The parent psychological appointment will be conducted by the researcher, in a place and time different from the child's. It will take 30 minutes in a private room, every 15 days. After 6 months of treatment, the parent will have an appointment every 30 days for a period of 6 months.
The child will be seen separately from his/her parent, in separate place and time. The appointment will last 30 minutes, every 15 days, and a playful material will be used to facilitate the child’s care. After 6 months the children will be seen once every month for a period of 6 months.
2. Control Group: Children receive the care without psychological support to parents. After 6 months the children will be seen once every month for a period of 6 months.
Clinical outcome data will be recorded for further evaluations. Those who need follow-up assistance, after the survey period, will be forwarded to the psychology service.
Follow Up Length: 6 month(s); Study Entry : Single Randomisation only

Intervention type



Not Applicable

Drug names

Primary outcome measure

The results, that will be evaluated, after six months of intervention, are enuresis improvement (Nocturnal Diary), punishment frequency reduction, improvement in behavior problems, and evasion decrease.

Secondary outcome measures

Not provided at time of registration

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Patients between 6 and 19 years old who are attending the enuresis clinic and with monosymptomatic enuresis

Participant type


Age group




Target number of participants


Total final enrolment


Participant exclusion criteria

1. Those unwilling to participate in the research, or has difficulty in understanding the goals of it.
2. Patients with psychiatric, renal, neurological disorders, non-monosymptomatic enuresis
3. Those who are already undergoing other treatment for enuresis in the last six months

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Rua: Coronel Severiano de Resende, 191, centro.
Santos Dumont

Sponsor information


Federal University of Juiz de Fora (Universidade Federal de Juiz de Fora) (Brazil)

Sponsor details

Av. Eugênio do Nascimento s/no
Bairro Dom Bosco
Faculdade de Medicina
2o andar (ao lado do HU/CAS)
Juiz de Fora – MG
CEP 36038-330
55 (32) 2102 -3848

Sponsor type




Funder type


Funder name

Investigator initiated and funded (Brazil)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2020 results in (added 15/09/2020)

Publication citations

Additional files

Editorial Notes

15/09/2020: Publication reference and total final enrolment number added.