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
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
-
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.