Trial registered on ANZCTR


Trial ID
ACTRN12605000621617
Ethics application status
Approved
Date submitted
22/08/2005
Date registered
10/10/2005
Date last updated
10/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of vaginal prolapse repair employing mesh augmentation.
Scientific title
A comparison of the effectiveness of traditional vaginal colporraphy with colporraphay using mesh augmentation in women with vaginal prolapse as assessed using the pelvic organ prolpse quantification examination.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vaginal prolapse 748 0
Condition category
Condition code
Reproductive Health and Childbirth 824 824 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group- Vaginal colporaphy with the use of mesh.
Intervention code [1] 217 0
None
Comparator / control treatment
Control group- Traditional vaginal colporaphy.
Control group
Active

Outcomes
Primary outcome [1] 1056 0
A reduction in the risk of prolapse recurrence without a significant increased risk of morbidity with the use of mesh over a period of 12 months.
Timepoint [1] 1056 0
Secondary outcome [1] 1966 0
Absence of dysparunia
Timepoint [1] 1966 0
At 6 and 12 months post operatively.
Secondary outcome [2] 1967 0
Absence of bowel symptoms
Timepoint [2] 1967 0
At 6 and 12 months.
Secondary outcome [3] 1968 0
Absence of voiding problems
Timepoint [3] 1968 0
At 6 and 12 months.

Eligibility
Key inclusion criteria
Women with posterior and anterior vaginal wall prolapse with at least one site being of stage 2 or more.(ICS quantitative pelvic organ prolapse examination system).Women with cocomitant urinary symptoms and /or anorectal symptoms maybe included.Women requiring anterior and posterior repair.Women with urodynamic stress incontinence will be offered a mid urethral sling procedure.Willingness to participate.
Minimum age
Not stated
Maximum age
Not stated
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with apical or vault prolapse of stage 2 or more(ICS quantitative pelvic organ porlapse examination system).Medically unfit for surgery.Women undergoing concomittant abdominal surgery for prolapse eg abdominal sacral colpopexy, Paravaginal repair.Refusal to participate.

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)
Quasi randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisatio schedule was a computer generated table of random numbers. Blocking and stratification were both used. Blocks of four were used to achieve balanced numers in the two treatment groups
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
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] 912 0
Commercial sector/Industry
Name [1] 912 0
Johnson and Johnson
Address [1] 912 0
Country [1] 912 0
Primary sponsor type
Commercial sector/Industry
Name
Johnson and Johnson
Address
Country
United States of America
Secondary sponsor category [1] 771 0
Commercial sector/Industry
Name [1] 771 0
Johnson and Johnson
Address [1] 771 0
Country [1] 771 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2198 0
Royal Womens Hospital Melbourne
Ethics committee address [1] 2198 0
Ethics committee country [1] 2198 0
Australia
Date submitted for ethics approval [1] 2198 0
Approval date [1] 2198 0
Ethics approval number [1] 2198 0

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

Contacts
Principal investigator
Name 35653 0
Address 35653 0
Country 35653 0
Phone 35653 0
Fax 35653 0
Email 35653 0
Contact person for public queries
Name 9406 0
Dr Macus Carey
Address 9406 0
Suite D 10th floor
Francis Perry House
285 Cardigan St
Carlton VIC 3053
Country 9406 0
Australia
Phone 9406 0
+61 3 92215099
Fax 9406 0
Email 9406 0
marcus.carey@affinityhealth
Contact person for scientific queries
Name 334 0
Ann Cornish
Address 334 0
Royal Women's Hospital
132 Grattan St
Carlton VIC 3053
Country 334 0
Australia
Phone 334 0
+61 3 93442746
Fax 334 0
Email 334 0
ann.cornish@rwh.org.au