Effect of patient's position on the results of urodynamic investigation
ISRCTN | ISRCTN53395152 |
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DOI | https://doi.org/10.1186/ISRCTN53395152 |
Secondary identifying numbers | N0162147172 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 28/06/2010
- 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 Ami Shukla
Scientific
Scientific
Clinical Fellow Urogynaecology
Northampton General Hospital NHS Trust
Billing Road
Northampton
NN1 5BD
United Kingdom
Phone | +44 (0)1604 634700 |
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amishukla@hotmail.com |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Other |
Scientific title | |
Study objectives | The research question is based on the null hypothesis, that the supine or sitting position of the patient does not make any difference to the results of urodynamic investigation. |
Ethics approval(s) | Approved by the local research ethics committee |
Health condition(s) or problem(s) studied | Urinary incontinence |
Intervention | Randomised, cross-over study where each participant will serve as their own control by being randomised into one of two groups. 1. Group 1 will have the urodynamics performed first in a lying position followed by a sitting position 2. Group 2 will have the urodynamic performed first in a sitting position followed by a lying position |
Intervention type | Other |
Primary outcome measure | 1. Whether the position makes any difference in the results of the urodynamic study 2. Whether the women find one position better/more comfortable/less embarrassing over the other, or is there no preference from the women's perspective |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/06/2004 |
Completion date | 30/11/2004 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Female |
Target number of participants | 50 |
Key inclusion criteria | All women referred for urodynamic studies for incontinence to the urogynae department. 50 volunteers are required for the study, aged at least 18 years. |
Key exclusion criteria | Does not match inclusion criteria |
Date of first enrolment | 01/06/2004 |
Date of final enrolment | 30/11/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Clinical Fellow Urogynaecology
Northampton
NN1 5BD
United Kingdom
NN1 5BD
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Northampton General Hospital NHS Trust (UK) - NHS R&D Support Funding
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | 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 | 01/05/2006 | Yes | No |