A study to compare bladder function of healthy Asian and Caucasian women

ISRCTN	ISRCTN97337606
DOI	https://doi.org/10.1186/ISRCTN97337606
Secondary identifying numbers	UHL 10288 v1.1

Submission date: 10/08/2007
Registration date: 26/10/2007
Last edited: 18/01/2012

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 Douglas Tincello
Scientific

Reproductive Science Section
Cancer Studies and Molecular Medicine
Robert Kilpatrick Clinical Sciences Building
Leicester Royal Infirmary
PO Box 65
Leicester
LE2 7LX
United Kingdom

Phone	+44 (0)116 252 5813
Email	dgt4@le.ac.uk

Study information

Study design	Prospective observational cohort study.
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Other
Study type	Other
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	Fundamental physiological differences in bladder physiology exist between women of Caucasian and Asian origin.
Ethics approval(s)	Approved by Nottinghamshire Local Research Ethics Committee on the 16th April 2007 (ref: 07/Q2404/25)
Health condition(s) or problem(s) studied	Urinary incontinence
Intervention	Single urodynamic investigation with urethral pressure profile measurement.
Intervention type	Other
Primary outcome measure	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 study start date	01/06/2007
Completion date	31/05/2008

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Target number of participants	70
Key inclusion criteria	1. Women of South Indian Asian or Caucasian ethnic origin (self-specified) 2. Willing to undergo urodynamic assessment
Key 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
Date of first enrolment	01/06/2007
Date of final enrolment	31/05/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Reproductive Science Section

Leicester
LE2 7LX
United Kingdom

Sponsor information

University of Leicester (UK)
University/education

University Road
Leicester
LE1 7RH
England
United Kingdom

Phone	+44 (0)116 252 2522
Email	dw33@le.ac.uk
Website	http://www.le.ac.uk
"ROR"	https://ror.org/04h699437

Funders

Funder type

Industry

UCB Pharma Ltd (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2005		Yes	No