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Trial registered on ANZCTR


Registration number
ACTRN12609000112268
Ethics application status
Approved
Date submitted
17/02/2009
Date registered
18/02/2009
Date last updated
18/02/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of outcome following surgery for pelvic organ prolapse using two different types of mesh grafts
Scientific title
Comparison of objective and subjective success rates following surgery using the anterior-Prolift and Perigee systems in women with multi compartment pelvic organ prolapse
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvic Organ Prolapse 4339 0
Condition category
Condition code
Surgery 4580 4580 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Anterior vaginal repair using the anterior Prolift(TM) system (Ethicon Women’s Health and Urology, Somerville, NJ) and concminant procedures for the apical and posterior compartments and for stress urinary incontinence as required. The anterior Prolift system is a transvaginal surgical kit designed for the treatment of anterior vaginal wall prolapse. It consists of a synthetic mesh graft with four arms. The graft is placed between the bladder and the anterior vaginal wall without tension and the arms retrieved through the Obturator foramen using special trocars. This surgical procedure is a 'one off' procedure.
Intervention code [1] 4073 0
Treatment: Surgery
Comparator / control treatment
Anterior vaginal repair using the Perigee(TM) system (American Medical Systems Inc. Minnetonka, MN) and concminant procedures for the apical and posterior compartments and for stress urinary incontinence as required. The Perigee system is a transvaginal surgical kit designed for the treatment of anterior vaginal wall prolapse. It consists of a synthetic mesh graft with four arms. The graft is placed between the bladder and the anterior vaginal wall without tension and the arms retrieved through the Obturator foramen using special trocars. This surgical procedure is a 'one off' procedure. The Perigee and the Prolift systems are manufectured by different companies and differ from each other in few parameters including mainly the measurements and shape of the mesh graft and arms and the shape of the retrieving trocars. These differences can potentially lead to differences in the safety and efficacy of the two procedures.
Control group
Active

Outcomes
Primary outcome [1] 5459 0
Objective success rate, defined as less than stage 2 prolapse at the anterior vaginal wall and at all compartments, according to the Pelvic Organ Prolapse Quantification system (POP-Q)
Timepoint [1] 5459 0
Six weeks postoperatively and six-monthly thereafter for 2 years
Secondary outcome [1] 9185 0
Subjective success rate, defind as no prolapse sensation
Timepoint [1] 9185 0
Six weeks postoperatively and six-monthly thereafter for 2 years
Secondary outcome [2] 9186 0
Patient's satisfaction expressed on a 1 to 10 Visual Analogue Scale
Timepoint [2] 9186 0
Six weeks postoperatively and six-monthly thereafter for 2 years
Secondary outcome [3] 9187 0
Fubctional (bladder bowel and sexual) outcomes using a validated pelvic floor symptom and quality of life questionnaire (the Queensland Pelvic Floor Questionnaire)
Timepoint [3] 9187 0
Six weeks postoperatively and six-monthly thereafter for 2 years
Secondary outcome [4] 9188 0
Complication rates. Data on perioperative complications (Bladder / bowel injury, blood loss > 400ml, blood transfusions) will be taken from the patients' charts, mesh related complications (erosion, contraction) will be assessed through pelvic examination and complications affecting functional outcomes (dyspareunia) will br assessed through interview and validated questionnaires.
Timepoint [4] 9188 0
Six weeks postoperatively and six-monthly thereafter for 2 years
Secondary outcome [5] 9189 0
Re-operation rates. This information will be retrieved from the clinic's records.
Timepoint [5] 9189 0
Six weeks postoperatively and six-monthly thereafter for 2 years

Eligibility
Key inclusion criteria
Women with symptomatic stage 2 (POP-Q) or more anterior vaginal prolapse
Minimum age
18 Years
Maximum age
90 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Stage 0 or 1 anterior vaginal support, ongoing pregnancy, prior mesh implantation and inability to give informed consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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 design features
Our team operates in three locations. At the Mater hospital the Prolift system is routinely used for all patients undergoing mesh repair for anterior vaginal prolapse, at the Wesley hospital the Perigee system is routinely used for all patients undergoing mesh repair for anterior vaginal prolapse and at the RBWH both systems are routinely used depending on availability at the time of surgery.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
24/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1514 0
4029
Recruitment postcode(s) [2] 1515 0
4066
Recruitment postcode(s) [3] 1516 0
4101

Funding & Sponsors
Funding source category [1] 4513 0
Charities/Societies/Foundations
Name [1] 4513 0
Australian Gynaecological Endoscopy Society
Country [1] 4513 0
Australia
Primary sponsor type
Individual
Name
A/Prof. Christopher Maher
Address
The Wesley Hospital
Sandford Jackson Building
Suite 86 / Level 4
30 Chasely Street
AUCHENFLOWER QLD 4066
Country
Australia
Secondary sponsor category [1] 4081 0
Individual
Name [1] 4081 0
Dr. Benjamin Feiner
Address [1] 4081 0
The Wesley Hospital
Sandford Jackson Building
Suite 86 / Level 4
30 Chasely Street
AUCHENFLOWER QLD 4066
Country [1] 4081 0
Australia
Other collaborator category [1] 570 0
Individual
Name [1] 570 0
Dr. Peter O'Rouke
Address [1] 570 0
QIMR/RBWH Statistics Unit
Level B Clive Berghofer CRC building
Queensland Institute of Medical Research
Post Office Royal Brisbane Hospital
Country [1] 570 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6573 0
Royal Brisbane and Women's Hospital (RBWH) Health Service District Ethics Committee
Ethics committee address [1] 6573 0
Ethics committee country [1] 6573 0
Australia
Date submitted for ethics approval [1] 6573 0
12/06/2008
Approval date [1] 6573 0
29/08/2008
Ethics approval number [1] 6573 0

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

Contacts
Principal investigator
Name 29297 0
Address 29297 0
Country 29297 0
Phone 29297 0
Fax 29297 0
Email 29297 0
Contact person for public queries
Name 12544 0
Dr. Benjamin Feiner
Address 12544 0
The Wesley Hospital
Sandford Jackson Building
Suite 86 / Level 4
30 Chasely Street
AUCHENFLOWER QLD 4066
Country 12544 0
Australia
Phone 12544 0
0447 404 112
Fax 12544 0
Email 12544 0
feiner@tx.technion.ac.il
Contact person for scientific queries
Name 3472 0
Dr. Benjamin Feiner
Address 3472 0
The Wesley Hospital
Sandford Jackson Building
Suite 86 / Level 4
30 Chasely Street
AUCHENFLOWER QLD 4066
Country 3472 0
Australia
Phone 3472 0
0447 404 112
Fax 3472 0
Email 3472 0
feiner@tx.technion.ac.il

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.