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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN97337606 |
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Date of registration:
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26/10/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A study to compare bladder function of healthy Asian and Caucasian women
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Scientific title:
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Date of first enrolment:
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01/06/2007 |
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Target sample size:
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70 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN97337606 |
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Study type:
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Observational |
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Study design:
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Prospective observational cohort study. (Other)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Douglas
Tincello |
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Address:
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Reproductive Science Section
Cancer Studies and Molecular Medicine
Robert Kilpatrick Clinical Sciences Building
Leicester Royal Infirmary
PO Box 65
LE2 7LX
Leicester
United Kingdom |
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Telephone:
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+44 (0)116 252 5813 |
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Email:
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dgt4@le.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Women of South Indian Asian or Caucasian ethnic origin (self-specified)
2. Willing to undergo urodynamic assessment
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
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Urinary incontinence
Urological and Genital Diseases
Urinary incontinence
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Intervention(s)
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Single urodynamic investigation with urethral pressure profile measurement.
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Primary Outcome(s)
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Mean bladder capacity in the two ethnic groups.
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Secondary Outcome(s)
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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
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Secondary ID(s)
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UHL 10288 v1.1
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Source(s) of Monetary Support
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UCB Pharma Ltd (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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