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| A study to compare bladder function of healthy Asian and Caucasian women |
| Source of record | UK Trials |
| ISRCTN | ISRCTN97337606 |
| Date ISRCTN assigned | 26/10/2007 |
| Local reference number(s) | UHL 10288 v1.1 |
| Public title | A study to compare bladder function of healthy Asian and Caucasian women |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Urinary incontinence |
| Study hypothesis | Fundamental physiological differences in bladder physiology exist between women of Caucasian and Asian origin. |
| Design/methodology | Prospective observational cohort study. |
| Research ethics review | Approved by Nottinghamshire Local Research Ethics Committee on the 16th April 2007 (ref: 07/Q2404/25) |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Women of South Indian Asian or Caucasian ethnic origin (self-specified) 2. Willing to undergo urodynamic assessment |
| Participants - 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 |
| Patient information material | |
| Anticipated start date | 01/06/2007 |
| Anticipated end date | 31/05/2008 |
| Status of trial | Ongoing |
| Target number of participants | 70 |
| Interventions | Single urodynamic investigation with urethral pressure profile measurement. |
| Primary outcome measure(s) | Mean bladder capacity in the two ethnic groups. |
| Secondary outcome measure(s) | 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 |
| Sources of funding | UCB Pharma Ltd (UK) |
| Sponsor name | University of Leicester (UK) |
| Sponsor details | University Road Leicester United Kingdom LE1 7RH |
| Sponsor telephone | +44 (0)116 252 2522 |
| Sponsor fax | +44 (0)116 252 2200 |
| Sponsor email | dw33@le.ac.uk |
| Sponsor website | http://www.le.ac.uk |
| Contact name | Dr Douglas Tincello |
| Contact details | Reproductive Science Section Cancer Studies and Molecular Medicine Robert Kilpatrick Clinical Sciences Building Leicester Royal Infirmary PO Box 65 Leicester United Kingdom LE2 7LX |
| Contact telephone | +44 (0)116 252 5813 |
| Contact fax | +44 (0)116 252 5846 |
| Contact email | dgt4@le.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN97337606 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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