Condition category
Urological and Genital Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
28/06/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

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

  1. 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.

Additional files

Editorial Notes