Condition category
Mental and Behavioural Disorders
Date applied
26/09/2006
Date assigned
26/09/2006
Last edited
15/04/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M Kamphuis

ORCID ID

Contact details

TNO Quality of life
P.O. Box 2215
Leiden
2301 CE
Netherlands
+31 (0)71 5181794
Mascha.Kamphuis@tno.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR690

Study information

Scientific title

Acronym

BET-project (Bedwetting Effective Techniques)

Study hypothesis

Interventions such as the calender method and waking up will increase the number of children getting continent compared to doing nothing (control group).

Ethics approval

Received from the local medical ethics committee

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Bedwetting

Intervention

1. Waking up with password
2. Waking up without password
3. Calender method

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

No bedwetting, that is: dry nights at least 14 days in a row.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/12/2004

Overall trial end date

01/10/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children aged four and five years, bedwetting more than two night per week
2. Parents speak Dutch

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

581

Participant exclusion criteria

Being treated with medication or alarm treament of possible pathology for bed wetting.

Recruitment start date

01/12/2004

Recruitment end date

01/10/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

TNO Quality of life
Leiden
2301 CE
Netherlands

Sponsor information

Organisation

TNO Quality of Life (Netherlands)

Sponsor details

Division of Child Health
Prevention and Physical Activity
P.O. Box 2215
Leiden
2301 CE
Netherlands

Sponsor type

Government

Website

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19167725

Publication citations

  1. Results

    van Dommelen P, Kamphuis M, van Leerdam FJ, de Wilde JA, Rijpstra A, Campagne AE, Verkerk PH, The short- and long-term effects of simple behavioral interventions for nocturnal enuresis in young children: a randomized controlled trial., J. Pediatr., 2009, 154, 5, 662-666, doi: 10.1016/j.jpeds.2008.12.001.

Additional files

Editorial Notes