Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000314820
Ethics application status
Approved
Date submitted
9/03/2012
Date registered
20/03/2012
Date last updated
20/03/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised trial comparing two vaginal prolene sling surgeries for female urinary incontinence
Scientific title
A randomised trial comparing two vaginal prolene sling surgeries for female urinary incontinence
Secondary ID [1] 280102 0
None
Universal Trial Number (UTN)
U111-1129-0049
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stress urinary incontinence 286015 0
suburethral sling surgery 286100 0
Condition category
Condition code
Surgery 286203 286203 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Suburethral sling surgery with randomisation to Monarc or Mini-arc.
Both are surgical devices made of polypropylene that are placed underneath the mid urethra. Both procedures take about 20minutes, however the Monarch is more invasive with 3 incisions, whilst the Mini-arc only has a single incision.
Intervention code [1] 284428 0
Treatment: Surgery
Comparator / control treatment
the Monarc is the control, as it is the established surgical procedure
Control group
Active

Outcomes
Primary outcome [1] 286677 0
post operative pain relief, assessed by pain scoring on a visual analogue scale from 0 to 10
Timepoint [1] 286677 0
4 hours post operatively
Primary outcome [2] 286680 0
continence, assessed by bladder diaries over 2 days and clinical examination
Timepoint [2] 286680 0
2 day bladder diary and clinical examination at 6 months
Secondary outcome [1] 296447 0
blood loss, assessed by surgeons assessment
Timepoint [1] 296447 0
intraoperatively

Eligibility
Key inclusion criteria
no other surgery required, females only ages 16 - 90, urodynamically proven stress incontinence & fit for surgery
Minimum age
16 Years
Maximum age
90 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
prolapse, detrusor overactivity or voiding difficulty, unit for surgery

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)
invited to participate from doctors rooms after urodynamically proven stress urinary incontinence documented. Allocation was not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated odd or even number at the time of surgery
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284858 0
Self funded/Unfunded
Name [1] 284858 0
Dr Andrew Foote
Country [1] 284858 0
Australia
Primary sponsor type
Individual
Name
Dr Andrew Foote
Address
9/3 Sydney Ave, Barton. ACT. 2600
Country
Australia
Secondary sponsor category [1] 283737 0
None
Name [1] 283737 0
Address [1] 283737 0
Country [1] 283737 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286848 0
Calvary Ethics Committee, Bruce
Ethics committee address [1] 286848 0
Calvary Hospital
Mary Potter Ct
Bruce. ACT. 2614
Ethics committee country [1] 286848 0
Australia
Date submitted for ethics approval [1] 286848 0
Approval date [1] 286848 0
01/06/2011
Ethics approval number [1] 286848 0

Summary
Brief summary
50 females with urodynamically proven stress incontience will be randomised to either Monarc or Miniarc suburethral sling surgery and compared with regard to postoperative pain relief, blood loss, and continence at 6 months
Trial website
nil
Trial related presentations / publications
nil yet
Public notes

Contacts
Principal investigator
Name 33886 0
Address 33886 0
Country 33886 0
Phone 33886 0
Fax 33886 0
Email 33886 0
Contact person for public queries
Name 17133 0
Dr Andrew Foote
Address 17133 0
9/3 Sydney Ave, Barton. ACT. 2600
Country 17133 0
Australia
Phone 17133 0
+61262533399
Fax 17133 0
+61262533900
Email 17133 0
[email protected]
Contact person for scientific queries
Name 8061 0
Dr Andrew Foote
Address 8061 0
9/3 Sydney Ave, Barton. ACT. 2600
Country 8061 0
Australia
Phone 8061 0
+61262533399
Fax 8061 0
+61262533900
Email 8061 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.