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Trial registered on ANZCTR


Trial ID
ACTRN12605000439640
Ethics application status
Approved
Date submitted
15/08/2005
Date registered
20/09/2005
Date last updated
20/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Open versus Laparoscopic Burch colposuspension: a randomised controlled trial.
Scientific title
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.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress urinary incontinence 551 0
Condition category
Condition code
Renal and Urogenital 629 629 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Laparoscopic or open Burch colposuspension performed on women with genuine stress urinary incontinence.
Intervention code [1] 192 0
Treatment: surgery
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 737 0
Absence of stress urinary incontinence as measured by urodynamics
Timepoint [1] 737 0
6 months post operatively
Secondary outcome [1] 1515 0
Postoperative pain and analgesic requirements for both procedures.
Timepoint [1] 1515 0
Secondary outcome [2] 1516 0
Time taken to return to normal activities.
Timepoint [2] 1516 0
Secondary outcome [3] 1517 0
Impact of surgical intervention on patients quality oif life.
Timepoint [3] 1517 0
Secondary outcome [4] 1518 0
Cost difference between open and laparoscopic procedures.
Timepoint [4] 1518 0

Eligibility
Key inclusion criteria
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 687 0
Hospital
Name [1] 687 0
Urogynaecology Unit Royal Womens Hospital
Address [1] 687 0
Country [1] 687 0
Australia
Primary sponsor type
Hospital
Name
Urogynaecology unit Royal womens Hospital
Address
Country
Australia
Secondary sponsor category [1] 575 0
None
Name [1] 575 0
As above
Address [1] 575 0
Country [1] 575 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1880 0
Royal Womens Hospital Melbourne
Ethics committee address [1] 1880 0
Ethics committee country [1] 1880 0
Australia
Date submitted for ethics approval [1] 1880 0
Approval date [1] 1880 0
Ethics approval number [1] 1880 0
Ethics committee name [2] 1881 0
Mercy Hospital for Women
Ethics committee address [2] 1881 0
Ethics committee country [2] 1881 0
Australia
Date submitted for ethics approval [2] 1881 0
Approval date [2] 1881 0
Ethics approval number [2] 1881 0
Ethics committee name [3] 1882 0
Monash medical Centre
Ethics committee address [3] 1882 0
Ethics committee country [3] 1882 0
Australia
Date submitted for ethics approval [3] 1882 0
Approval date [3] 1882 0
Ethics approval number [3] 1882 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35817 0
Address 35817 0
Country 35817 0
Phone 35817 0
Fax 35817 0
Email 35817 0
Contact person for public queries
Name 9381 0
Dr Marcus Carey
Address 9381 0
Suite D 10th Floor
Francis Perry House
285 Cardigan Street
Carlton VIC 3053
Country 9381 0
Australia
Phone 9381 0
+61 3 92215099
Fax 9381 0
Email 9381 0
marcus.carey@affinityhealth.com.au
Contact person for scientific queries
Name 309 0
Ann Cornish
Address 309 0
Royal Womens Hospital
132 Grattan Street
Carlton VIC 3053
Country 309 0
Australia
Phone 309 0
+61 3 93442746
Fax 309 0
Email 309 0
ann.cornish@rwh.org.au