Contact information
Type
Scientific
Primary contact
Dr Ami Shukla
ORCID ID
Contact details
Clinical Fellow Urogynaecology
Northampton General Hospital NHS Trust
Billing Road
Northampton
NN1 5BD
United Kingdom
+44 (0)1604 634700
amishukla@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0162147172
Study information
Scientific title
Acronym
Study hypothesis
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
Approved by the local research ethics committee
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/06/2004
Overall trial end date
30/11/2004
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
50
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/06/2004
Recruitment end date
30/11/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Clinical Fellow Urogynaecology
Northampton
NN1 5BD
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Northampton General Hospital NHS Trust (UK) - NHS R&D Support Funding
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
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16001131
Publication citations
-
Results
Shukla A, Johnson D, Bibby J, Impact of patient position on filling phase of urodynamics in women., Int Urogynecol J Pelvic Floor Dysfunct, 2006, 17, 3, 231-233, doi: 10.1007/s00192-005-1350-1.