Condition category
Urological and Genital Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
18/01/2008
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 Patrick Davies

ORCID ID

Contact details

C/O Research and Effectiveness Department
Level 1 Old Building
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom
+44 0117 928 3473
R&Eoffice@ubht.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0264171565

Study information

Scientific title

Acronym

Study hypothesis

Does use of a vibrating bladder stimulator alter the time taken to pass urine in children?

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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Urological and Genital Diseases:

Intervention

RCT:
1. Advice
2. Device

The patients will be assigned to one of two groups: the 'advice' and the 'device' groups. The advice group will be given an advice leaflet which has some tips on how to try to stimulate urine flow. The device group will be shown the use of a bladder stimulator. This is a hand-held vibrating disk which is non-painful and has no known side effects. It is pressed on to the lower abdomen and vibrates the bladder, with the aim of stimulating urine flow. The idea behind this stimulator is that the vibrations of the bladder cause a reflex reaction which leads to urine flow.

Half of the patients will be in each group: which group the individuals go in to is decided at random. This is to minimise the possible effects of patients becoming frustrated at perceived preferential treatment within the waiting room area. Full informed consent will be obtained.

The parents would be given a clock and asked to write down when the urine is passed. If a sample is passed and is missed by the parents, this still counts as a time to pass urine. A questionnaire is also given which will ask some questions on the child and their illness, as well as how they think the child coped with the urine collection process.

This is then the end of the study and there will be no further input for the child or their parents.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Time to pass urine from taking the nappy off to urine flow.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2005

Overall trial end date

01/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

All children to give a urine sample who are not continent of urine (by day or night) attending to the Paediatric Emergency Department at the Bristol Children's Hospital will be asked to take part.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

97

Participant exclusion criteria

1. Children too unwell, in the opinion of the doctor treating
2. Those who do not need a clean sample of urine (so could have a urine bag)
3. Those who in the opinion of the consent taker, have insufficient understanding (due to language or other factors) of the trial process
4. Those who do not have a legal guardian with them
5. Those who have abnormalities in their anatomy or nerves which affect their ability to pass urine

Recruitment start date

01/09/2005

Recruitment end date

01/03/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

C/O Research and Effectiveness Department
Bristol
BS2 8HW
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

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.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

United Bristol Healthcare NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding (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

Results in http://www.ncbi.nlm.nih.gov/pubmed/18192318

Publication citations

  1. Results

    Davies P, Greenwood R, Benger J, Randomised trial of a vibrating bladder stimulator--the time to pee study., Arch. Dis. Child., 2008, 93, 5, 423-424, doi: 10.1136/adc.2007.116160.

Additional files

Editorial Notes