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ISRCTN
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ISRCTN53395152
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ClinicalTrials.gov identifier
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Public title
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Effect of patient's position on the results of urodynamic investigation
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0162147172
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Approved by the local research ethics committee
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Urinary incontinence
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Participants - inclusion criteria
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All women referred for urodynamic studies for incontinence to the urogynae department. 50 volunteers are required for the study, aged at least 18 years.
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Participants - exclusion criteria
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Does not match inclusion criteria
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Anticipated start date
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01/06/2004
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Anticipated end date
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30/11/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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50
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Interventions
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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
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Northampton General Hospital NHS Trust (UK) - NHS R&D Support Funding
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Trial website
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Publications
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2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16001131
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Contact name
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Dr
Ami
Shukla
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Address
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Clinical Fellow Urogynaecology
Northampton General Hospital NHS Trust
Billing Road
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City/town
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Northampton
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Zip/Postcode
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NN1 5BD
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Country
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United Kingdom
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Tel
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+44 (0)1604 634700
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Fax
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+44 (0)1604 545906
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Email
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amishukla@hotmail.com
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Sponsor
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Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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28/06/2010
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Date ISRCTN assigned
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30/09/2005
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