Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000110280
Ethics application status
Approved
Date submitted
29/01/2009
Date registered
18/02/2009
Date last updated
18/02/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Uterine suspension and vaginal repair with mesh in the management of uterovaginal prolapse: Outcome of 100 women at 12 months follow-up
Scientific title
Anterior vaginal mesh Sacrospinous hysteropexy and posterior repair for multi-compartment uterovaginal prolapse
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvic Organ Prolapse 4251 0
Condition category
Condition code
Surgery 4473 4473 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The whole surgery is performed through the vaginal route and includes the following components: Anterior vaginal mesh (anterior Prolift system) repair, Sacrospinous hysteropexy and posterior fascial plication. 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] 3973 0
Treatment: Surgery
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5352 0
Objective (anatomical) success rate, defined as less than stage 2 prolapse at all compartments according to the Pelvic Organ Prolapse Quantification system (POP-Q)
Timepoint [1] 5352 0
six weeks post-operatively and six-monthly thereafter for 2 years
Secondary outcome [1] 8995 0
Subjective success rate, defined as no prolapse sensation (Queensland Pelvic Floor Questionnaire, a validated symptom and quality of life questionnaire)
Timepoint [1] 8995 0
six weeks post-operatively and six-monthly thereafter for 2 years
Secondary outcome [2] 8996 0
patients' satisfaction on a 1 to 10 Visual Analogue Scale (VAS)
Timepoint [2] 8996 0
six weeks post-operatively and six-monthly thereafter for 2 years
Secondary outcome [3] 8997 0
functional (bladder, bowel and sexual) outcomes (Queensland Pelvic Floor Questionnaire, a validated symptom and quality of life questionnaire)
Timepoint [3] 8997 0
six weeks post-operatively and six-monthly thereafter for 2 years
Secondary outcome [4] 8998 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] 8998 0
six weeks post-operatively and six-monthly thereafter for 2 years

Eligibility
Key inclusion criteria
Stage two or more anterior compartment prolapse with stage one or more uterine and posterior compartment prolapse and willingness to consider uterine preservation surgery
Minimum age
18 Years
Maximum age
90 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Uterine or cervical pathology, abnormal menstrual bleeding, 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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/10/2007
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)

Funding & Sponsors
Funding source category [1] 4429 0
Self funded/Unfunded
Name [1] 4429 0
Benjamin Feiner, MD
Country [1] 4429 0
Australia
Primary sponsor type
Individual
Name
A/Prof. Christopher Maher
Address
Wesley Urogynaecology Unit
The Wesley Hospital
Sandford Jackson Building
Suite 86 / Level 4
30 Chasely Street
Auchenflower
QLD 4066
Country
Australia
Secondary sponsor category [1] 3989 0
None
Name [1] 3989 0
Address [1] 3989 0
Country [1] 3989 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6478 0
UnitingCare Health Service Human Research Ethics Committee
Ethics committee address [1] 6478 0
PO Box 499
Toowong
QLD 4066
Ethics committee country [1] 6478 0
Australia
Date submitted for ethics approval [1] 6478 0
12/07/2007
Approval date [1] 6478 0
03/10/2007
Ethics approval number [1] 6478 0

Summary
Brief summary
This study aimed to evaluated the efficacy and safety of anterior vaginal mesh repair, sacrospinous hysteropexy and posterior fascial plication in the management of anterior compartment dominated uterovaginal prolapse. Patient’s demographics, medical and obstetric history, previous surgeries, pre-operative POP-Q and peri-operative information were collected. Post-operative patient evaluation occurred at six weeks and six-monthly thereafter and included pelvic examination (POP-Q), patients’ satisfaction and 2 additional questions: ‘would you have chosen again to undergo this surgery?’ and ‘would you recommend this surgery to a friend with a similar condition?’ The primary outcome measure of this study was the objective success rate, defined as less than stage 2 prolapse at all compartments. Secondary outcome measures included subjective success rate (defined as no prolapse sensation), patients’ satisfaction, functional (bladder, bowel and sexual) outcomes and complication rates.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29231 0
Address 29231 0
Country 29231 0
Phone 29231 0
Fax 29231 0
Email 29231 0
Contact person for public queries
Name 12478 0
Dr. Benjamin Feiner
Address 12478 0
Wesley Urogynaecology Unit
The Wesley Hospital
Sandford Jackson Building
Suite 86 / Level 4
30 Chasely Street
Auchenflower
QLD 4066
Country 12478 0
Australia
Phone 12478 0
+61 447 404 112
Fax 12478 0
Email 12478 0
[email protected]
Contact person for scientific queries
Name 3406 0
Dr. Benjamin Feiner
Address 3406 0
Wesley Urogynaecology Unit
The Wesley Hospital
Sandford Jackson Building
Suite 86 / Level 4
30 Chasely Street
Auchenflower
QLD 4066
Country 3406 0
Australia
Phone 3406 0
+61 447 404 112
Fax 3406 0
Email 3406 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
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