Effect of patient's position on the results of urodynamic investigation

ISRCTN	ISRCTN53395152
DOI	https://doi.org/10.1186/ISRCTN53395152
Protocol serial number	N0162147172
Sponsor	Department of Health
Funder	Northampton General Hospital NHS Trust (UK) - NHS R&D Support Funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Ami Shukla
Scientific

Clinical Fellow Urogynaecology
Northampton General Hospital NHS Trust
Billing Road
Northampton
NN1 5BD
United Kingdom

Phone	+44 (0)1604 634700
Email	amishukla@hotmail.com

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/11/2004

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	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

Clinical Fellow Urogynaecology

Northampton
NN1 5BD
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2006		Yes	No