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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Anterior Elevate or Laparoscopic Abdominal Sacrocolpopexy in women with post hysterectomy apical prolapse – a Randomised Controlled Trial
Scientific title
In patients with post hysterectomy prolapse, is Anterior Elevate mesh kit as good as or better than Laparoscopic Sacrocolpopexy for prolapse recurrence
Secondary ID [1] 273254 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post hysterectomy vaginal vault prolapse 279018 0
Condition category
Condition code
Renal and Urogenital 279204 279204 0 0
Other renal and urogenital disorders

Study type
Description of intervention(s) / exposure
Anterior Elevate mesh kit

to provide support, a synthetic monofilament polypropylene mesh (permanent) is placed under the bladder and top of vagina, via a vagina incision in this operation that could take up to 1.5 hours
Intervention code [1] 269595 0
Treatment: Surgery
Intervention code [2] 269596 0
Treatment: Devices
Comparator / control treatment
Laparoscopic Sacrocolpopexy

to provide support, a synthetic monofilament polypropylene mesh (permanent) is placed under the bladder and top of vagina, via a laparoscopic (keyhole in abdomen) incision in this operation that could take up to 2.5 hours
Control group

Primary outcome [1] 279839 0
Incidence of apical prolapse greater or equal to stage 2 (Point C below -1cm)
Timepoint [1] 279839 0
12 months & 36 months
Secondary outcome [1] 294547 0
Incidence of overall prolapse greater or equal to stage 2
Timepoint [1] 294547 0
12 months & 36 months
Secondary outcome [2] 294548 0
subjective prolapse symptom score using PFDI-20
Timepoint [2] 294548 0
12 months & 36 months
Secondary outcome [3] 294549 0
(prolapse) symptom impact using PFIQ 7
Timepoint [3] 294549 0
12 months & 36 months
Secondary outcome [4] 294550 0
global impression of improvement using PGI-I
Timepoint [4] 294550 0
12 months & 36 months
Secondary outcome [5] 294551 0
sexual function using PISQ 12
Timepoint [5] 294551 0
12 months & 36 months

Key inclusion criteria
1.patients with symptomatic post hysterectomy Apical Prolapse greater or equal to Stage 2 (point C greater than or equal to -1) referred for surgery
2.Willing to participate and return for follow up
3.able to provide informed consent
Minimum age
18 Years
Maximum age
80 Years
Can healthy volunteers participate?
Key exclusion criteria
1.Unable to undergo GA
2.Unable to understand questionnaires, give informed consent or return for review
3.BMI >35
4. more than or equal to 5 laparotomies
5. Previous synthetic mesh used for POP
6. Previous sacro colpopexy
7. total vaginal length < 6cm
8. chronic pelvic pain
9. Genito urinary anomaly (congenital)
10.Neurogenic bladder disorders
11.Previous radiation therapy to pelvis
12.Past history of any form of fistula involving the vagina
13.Allergy to polypropylene or local anaesthetic

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Symptomatic patients referred for surgery will be assessed and recruited from pelvic floor clinic or urodynamic clinic. Random allocation involved contacting the holder of the allocation schedule who was at central administration
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated random table, stratified to centres
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284081 0
Self funded/Unfunded
Name [1] 284081 0
Address [1] 284081 0
Country [1] 284081 0
Primary sponsor type
Anna Rosamilia
Suite 8, Cabrini Medical Centre Malvern
183 Wattletree Road, VIC 3144
Secondary sponsor category [1] 269048 0
Name [1] 269048 0
Joseph Lee
Address [1] 269048 0
c/o Pelvic Floor Clinic
Monash Moorabbin
823-865 Centre Road
East Bentleigh VIC 3165
Country [1] 269048 0

Ethics approval
Ethics application status
Ethics committee name [1] 272039 0
Southern Health HREC
Ethics committee address [1] 272039 0
Research Directorate
Southern Health
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Ethics committee country [1] 272039 0
Date submitted for ethics approval [1] 272039 0
Approval date [1] 272039 0
Ethics approval number [1] 272039 0

Brief summary
Female pelvic organ prolapse, which is a protrusion of vaginal walls beyond the hymen, is both common and have a high burden of suffering. The traditional operation to treat post hysterectomy vaginal apical prolapse has been either abdominal sacrocolpopexy or vaginal sacrospinous fixation. Although the abdominal approach comes with a greater cure rate, it has a longer operating time, longer return to Activities of Daily Living and costs more than the vaginal approach. Modern advances involve the development of minimally invasive procedures which included a laparoscopic approach to abdominal sacrocolpopexy and also the introduction of vaginal mesh kits which provides better success rates when compared to the traditional vaginal operation, although not without its own sets of operative morbidity. These procedures involve inserting synthetic material anchored to the sacrospinous ligament to provide reinforcement and support to the vagina following its repair. Anterior Elevate is a new mesh kit which utilises a standard synthetic mesh using a surgical approach (anterior sacrospinous) that has been well established since 2001. The purpose of this project is to evaluate the success of Anterior Elevate vaginal mesh support or laparoscopic sacrocolpopexy in the treatment of women with vaginal apical prolapse.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 33297 0
Address 33297 0
Country 33297 0
Phone 33297 0
Fax 33297 0
Email 33297 0
Contact person for public queries
Name 16544 0
Alison Leitch
Address 16544 0
c/o Urodynamic Clinic
Monash Moorabbin
823-865 Centre Road
East Bentleigh VIC 3165
Country 16544 0
Phone 16544 0
Fax 16544 0
Email 16544 0
Contact person for scientific queries
Name 7472 0
Joseph Lee
Address 7472 0
c/o Pelvic Floor Clinic
Monash Moorabbin
823-865 Centre Road
East Bentleigh VIC 3165
Country 7472 0
Phone 7472 0
Fax 7472 0
Email 7472 0

No information has been provided regarding IPD availability
Summary results
No Results