Condition category
Mental and Behavioural Disorders
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
03/12/2008
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 J Evans

ORCID ID

Contact details

Department of Paediatrics
Nottingham City Hospital NHS Trust
Hucknall Road
Nottingham
NG1 1PB
United Kingdom
+44 (0)115 969 1169 ext 46455

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RBF 96X36

Study information

Scientific title

Acronym

Study hypothesis

To evaluate a multimedia education package, developed to educate children about their enuresis, for its effect on: clinical outcome; child and parent satisfaction; and children's levels of self-esteem.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Mental and behavioural disorders: Other mental disorder; Urological and genital diseases: Other urological and genital disease

Intervention

1. Five clinics will continue to provide standard information to the children and parents
2. Five clinics will utilise the multimedia education package
3. Five clinics will provide the same information as the multi-media package but in printed leaflet form

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Measures that are routinely monitored in the treatment of enuresis: number of children who become 'dry'; length of treatment time to attain 'dry' status; and relapse rates at the standard 6 month appointment.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/1997

Overall trial end date

30/06/1999

Reason abandoned

Eligibility

Participant inclusion criteria

The project would follow children through the standardised treatment protocol for enuresis in Leicester Community Trust (28 clinics in all). Five clinics would provide standard information and care, five would use the multimedia package, and five printed information with similar content to that of the package. 300 children, divided into three groups, 100 children for each experimental condition.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/07/1997

Recruitment end date

30/06/1999

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Paediatrics
Nottingham
NG1 1PB
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Trent (UK)

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

2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12603357

Publication citations

  1. Results

    Redsell SA, Collier J, Garrud P, Evans JH, Cawood C, Multimedia versus written information for nocturnal enuresis education: a cluster randomized controlled trial., Child Care Health Dev, 2003, 29, 2, 121-129.

Additional files

Editorial Notes