A study to compare bladder function of healthy Asian and Caucasian women
| ISRCTN | ISRCTN97337606 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97337606 |
| Protocol serial number | UHL 10288 v1.1 |
| Sponsor | University of Leicester (UK) |
| Funder | UCB Pharma Ltd (UK) |
- 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
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 |
|---|---|
| dgt4@le.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective observational cohort study. |
| Secondary study design | Cohort study |
| Study type | Participant 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(s) |
Mean bladder capacity in the two ethnic groups. |
| Key secondary outcome measure(s) |
The following will be compared between the two ethinic groups: |
| Completion date | 31/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Reproductive Science Section
Leicester
LE2 7LX
United Kingdom
LE2 7LX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
