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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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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12605000439640 |
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Date of registration:
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20/09/2005 |
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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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Open versus Laparoscopic Burch colposuspension: a randomised controlled trial.
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Scientific title:
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Laparoscopic versus open colposuspension for women with stress urinary incontinence: A prospective multicentre randomised single blind comparison of urodynamic cure of stress urinary incontinence at 6 months following surgery. |
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Date of first enrolment:
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24/01/1997 |
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Target sample size:
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200 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://anzctr.org.au/ACTRN12605000439640.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Other;Type of endpoint: Efficacy;
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Phase:
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Countries of recruitment
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Australia
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Contacts
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Name:
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Dr Marcus Carey
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Address:
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Suite D 10th Floor
Francis Perry House
285 Cardigan Street
Carlton VIC 3053
Australia |
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Telephone:
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+61 3 92215099 |
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Email:
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marcus.carey@affinityhealth.com.au |
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Affiliation:
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Name:
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Ann Cornish
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Address:
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Royal Womens Hospital
132 Grattan Street
Carlton VIC 3053
Australia |
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Telephone:
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+61 3 93442746 |
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Email:
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ann.cornish@rwh.org.au |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria:
Age minimum:
Not stated
Age maximum:
Not stated
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Renal and Urogenital - Other renal and urogenital disorders
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Stress urinary incontinence;
Stress urinary incontinence
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Intervention(s)
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Laparoscopic or open Burch colposuspension performed on women with genuine stress urinary incontinence.
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Primary Outcome(s)
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Absence of stress urinary incontinence as measured by urodynamics[6 months post operatively]
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Secondary Outcome(s)
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Postoperative pain and analgesic requirements for both procedures.[]
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Impact of surgical intervention on patients quality oif life.[]
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Time taken to return to normal activities.[]
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Cost difference between open and laparoscopic procedures.[]
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Source(s) of Monetary Support
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Urogynaecology Unit Royal Womens Hospital
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Ethics review
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Status: Not approved
Approval date:
Contact:
Mercy Hospital for Women
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Status: Not approved
Approval date:
Contact:
Monash medical Centre
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Status: Not approved
Approval date:
Contact:
Royal Womens Hospital Melbourne
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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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