Randomised trial of a vibrating bladder stimulator to induce urine flow in acute paediatrics
| ISRCTN | ISRCTN03252849 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03252849 |
| Protocol serial number | N0264171565 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funders | United Bristol Healthcare NHS Trust (UK), NHS R&D Support Funding (UK) |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 18/01/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Patrick Davies
Scientific
Scientific
C/O Research and Effectiveness Department
Level 1 Old Building
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom
| Phone | +44 0117 928 3473 |
|---|---|
| R&Eoffice@ubht.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Does use of a vibrating bladder stimulator alter the time taken to pass urine in children? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Time to pass urine from taking the nappy off to urine flow. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 97 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/09/2005 |
| Date of final enrolment | 01/03/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
C/O Research and Effectiveness Department
Bristol
BS2 8HW
United Kingdom
BS2 8HW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/05/2008 | Yes | No |
