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

ISRCTN ISRCTN53395152
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

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

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeOther
Scientific title
Study objectivesThe 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) studiedUrinary incontinence
InterventionRandomised, 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 typeOther
Primary outcome measure1. 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 measuresNot provided at time of registration
Overall study start date01/06/2004
Completion date30/11/2004

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants50
Key inclusion criteriaAll 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 criteriaDoes not match inclusion criteria
Date of first enrolment01/06/2004
Date of final enrolment30/11/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Clinical Fellow Urogynaecology
Northampton
NN1 5BD
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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