Condition category
Urological and Genital Diseases
Date applied
10/08/2007
Date assigned
26/10/2007
Last edited
18/01/2012
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 Douglas Tincello

ORCID ID

Contact details

Reproductive Science Section
Cancer Studies and Molecular Medicine
Robert Kilpatrick Clinical Sciences Building
Leicester Royal Infirmary
PO Box 65
Leicester
LE2 7LX
United Kingdom
+44 (0)116 252 5813
dgt4@le.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UHL 10288 v1.1

Study information

Scientific title

Acronym

Study hypothesis

Fundamental physiological differences in bladder physiology exist between women of Caucasian and Asian origin.

Ethics approval

Approved by Nottinghamshire Local Research Ethics Committee on the 16th April 2007 (ref: 07/Q2404/25)

Study design

Prospective observational cohort study.

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Urinary incontinence

Intervention

Single urodynamic investigation with urethral pressure profile measurement.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Mean bladder capacity in the two ethnic groups.

Secondary outcome measures

The following will be compared between the two ethinic groups:
1. Differences in mean residual volume
2. Maximum urinary flow rate
3. Average flow rate
4. Bladder volumes at defined sensations (first sensation of filling)
5. Detrusor pressure rise during filling
6. Detrusor pressure generated during voiding
7. Maximum urethral closure pressure
8. Functional urethral length

Overall trial start date

01/06/2007

Overall trial end date

31/05/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women of South Indian Asian or Caucasian ethnic origin (self-specified)
2. Willing to undergo urodynamic assessment

Participant type

Patient

Age group

Not Specified

Gender

Female

Target number of participants

70

Participant exclusion criteria

1. History of urinary tract infection within 3 months
2. History of recurrent urinary tract infection (3+ episodes in 12 months)
3. Previous pregnancy beyond 12 weeks gestation
4. Currently pregnant
5. Previous gynaecological or urological surgery (not including termination of first trimester pregnancy)
6. History of urinary tract abnormality
7. History of detrusor overactivity, childhood bedwetting
8. Current use (within 3 weeks) of anticholinergic medication, duloxetine or other drug with effects upon the urinary tract

Recruitment start date

01/06/2007

Recruitment end date

31/05/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Reproductive Science Section
Leicester
LE2 7LX
United Kingdom

Sponsor information

Organisation

University of Leicester (UK)

Sponsor details

University Road
Leicester
LE1 7RH
United Kingdom
+44 (0)116 252 2522
dw33@le.ac.uk

Sponsor type

University/education

Website

http://www.le.ac.uk

Funders

Funder type

Industry

Funder name

UCB Pharma Ltd (UK)

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

1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15947623

Publication citations

  1. Results

    Teo RE, Yisa S, Mayne C, Tincello D, A comparison of urodynamic diagnoses and detrusor muscle function in white and South Indian Asian women., J. Urol., 2005, 174, 1, 184-186, doi: 10.1097/01.ju.0000162074.42692.c7.

Additional files

Editorial Notes