Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS 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(s)
Approved by the local research ethics committee
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study 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
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
Overall study end date
30/11/2004
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
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
England, United Kingdom
Study 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 (0)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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2006 | Yes | No |