Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS 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(s)
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
Study setting(s)
Other
Study 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
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
Overall study end date
31/05/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women of South Indian Asian or Caucasian ethnic origin (self-specified)
2. Willing to undergo urodynamic assessment
Participant type(s)
Patient
Age group
Not Specified
Sex
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
England, United Kingdom
Study participating centre
Reproductive Science Section
Leicester
LE2 7LX
United Kingdom
Sponsor information
Organisation
University of Leicester (UK)
Sponsor details
University Road
Leicester
LE1 7RH
England
United Kingdom
+44 (0)116 252 2522
dw33@le.ac.uk
Sponsor type
University/education
Website
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2005 | Yes | No |