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Trial registered on ANZCTR


Registration number
ACTRN12621001246875p
Ethics application status
Submitted, not yet approved
Date submitted
19/07/2021
Date registered
15/09/2021
Date last updated
15/09/2021
Date data sharing statement initially provided
15/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing Vaginal And Laparoscopic Uterosacral Suspension For Pelvic Organ Prolapse
Scientific title
Symptomatic and anatomical recurrence following Vaginal Uterosacral Suspension Versus Laparoscopic Uterosacral Suspension for Pelvic Organ Prolapse- A Randomised Controlled Trial
Secondary ID [1] 304757 0
Nil
Universal Trial Number (UTN)
U1111-1267-8809
Trial acronym
The VULU (vaginal uterosacral, laparoscopic uterosacral) Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pelvic organ prolapse 322804 0
Condition category
Condition code
Surgery 320393 320393 0 0
Surgical techniques
Renal and Urogenital 320927 320927 0 0
Other renal and urogenital disorders
Reproductive Health and Childbirth 320928 320928 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Laparoscopic uterosacral ligament suspension (L-USLS). This is an operation already performed by the unit but we are comparing it to another routine suspension of the uterosacral ligament but perfromed vaginally (V-USLS)

Surgical approach in the laparoscopic group will conform to the following approach:
• Abdominal entry as per surgeon preference
• Laparoscopic hysterectomy with use of bipolar and monopolar instruments or vessel sealant device (eg. Ligasure, Harmonic etc)
• Use of McCartney tube or other device for colpotomy
• Vault suspension using 0 PDS or V-loc bilaterally with at least two bites of uterosacral ligament with attachment to vaginal vault
• Closure of vault
• Anterior vaginal repair with 2/0 PDS and 2/0 vicryl if residual defect after suspension
• Posterior repair if required with 2/0 PDS, 1 vicryl and 2/0 vicryl using site specific repair or midline plication
• Cystoscopy

Approximate duration 2.5 hours. Will be performed by gynaecologist or urogynaecologist.
Practitioners performing this operation have agreed to perform operation in this manner and feedback from the group has been sought to determine the most appropriate techniques.
Intervention code [1] 321195 0
Treatment: Surgery
Comparator / control treatment
vaginal uterosacral ligament suspension (V-USLS). Perfomed as follows:
• Vaginal hysterectomy as per surgeon preference
• Use of O PDS for high bilateral uterosacral suspension x2, sutured to vaginal vault or Modified McCall’s culdoplasty using O PDS or O v-loc
• Anterior wall repair if required as determined by surgeon
• Posterior repair if required
• Cystoscopy

Approximate duration 2 hours. Will be performed by gynaecologist or urogynaecologist.
Practitioners performing this operation have agreed to perform operation in this manner and feedback from the group has been sought to determine the most appropriate techniques.
Control group
Active

Outcomes
Primary outcome [1] 328305 0

To assess the success of L-USLS and V-USLS defined as combined:
• No symptomatic recurrence, No anatomical recurrence beyond the hymen for anterior and posterior repair and -1 for the vault and No pelvic organ prolapse (POP) retreatment (multiple components assessed as one primary outcome)
Timepoint [1] 328305 0
6 months, 2 years (primary endpoint) and 5 years post procdure
Secondary outcome [1] 398496 0
1. Anatomical:
a. All Pelvic Organ Prolapse Quantification (POP-Q) points- will assess POP recurrence
Timepoint [1] 398496 0
6 months, 2 years and 5 years post-procedure
Secondary outcome [2] 398497 0
2. Subjective success
a. Presence or absence of vaginal bulge according to participant assessed by asking the participant during follow up appointments: "do you feel a bulge, heaviness or dragging sensation in your vaginal area?"
Timepoint [2] 398497 0
6 months, 2 years and 5 years post-procedure
Secondary outcome [3] 398498 0
3. Reoperation
a Repeat surgery assessed by patient interview and/or accessing patient medical record
Timepoint [3] 398498 0
6 months, 2 years and 5 years post-procedure
Secondary outcome [4] 398499 0
Patient satisfaction- PGII
Timepoint [4] 398499 0
6 months, 2 years and 5 years post-procedure
Secondary outcome [5] 398500 0
Complications-Clavien-Dindo classification accessed by accessing medical record
Timepoint [5] 398500 0
6 months post-procedure
Secondary outcome [6] 398501 0
Inpatient outcomes
a. Post-operative pain- VAS scores and Analgaesia requirements by accessing medical record
Timepoint [6] 398501 0
Monitored for during of inpatient stay
Secondary outcome [7] 400078 0
Surgery for complications Accessed by patient interview and/or medical record
Timepoint [7] 400078 0
6 months, 2 years and 5 years post-procedure
Secondary outcome [8] 400079 0
Surgery for stress urinary incontinence (SUI) Accessed by patient interview and/or medical record
Timepoint [8] 400079 0
6 months, 2 years and 5 years post-procedure
Secondary outcome [9] 400080 0
Quality of life- POP distress inventory (POPDI)
Timepoint [9] 400080 0
6 months, 2 years and 5 years post-procedure
Secondary outcome [10] 400081 0
Bowel dysfunction- colorectal-anal distress inventory (CRADI-6)
Timepoint [10] 400081 0
6 months, 2 years and 5 years post-procedure
Secondary outcome [11] 400082 0
Sexual function- pelvic organ prolapse/ urinary incontinence sexual questionnaire (PISQ-12)
Timepoint [11] 400082 0
6 months, 2 years and 5 years post-procedure
Secondary outcome [12] 400083 0
Lower urinary tract symptoms- Urinary distress inventory (UDI-6)
Timepoint [12] 400083 0
6 months, 2 years and 5 years post-procedure
Secondary outcome [13] 400086 0
Ureteric kinking assessed by the presence or absence of ureteric jets intra-operatively during cystoscopy
Timepoint [13] 400086 0
6 months post procedure
Secondary outcome [14] 400089 0
Peri-operative outcomes
-Bloods loss assessed by accessing patient medical record
Timepoint [14] 400089 0
At time of surgery
Secondary outcome [15] 400090 0
Hospital stay length measured by accessing medical record
Timepoint [15] 400090 0
At completion of inpatient stay
Secondary outcome [16] 400091 0
Completion of planned adnexal surgery accessed by medical record or noted after surgery
Timepoint [16] 400091 0
At time of surgery

Eligibility
Key inclusion criteria
All participants between the ages of 18-80 with symptomatic stage II-III POP requesting surgery including hysterectomy
Capable of providing informed consent and able to return for follow up.
Minimum age
18 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Any previous prolapse surgery
Previous surgery in the treatment area in the last year.
Systemic steroids use within the last 3 months
Pelvic organ prolapse (POP) > stage 3 according to pelvic organ prolapse quantification system
Transvaginal mesh
Serious systemic disease or any chronic condition that could interfere with study compliance
Co-morbidities that would make a laparoscopic approach inappropriate
A surgical history that would make a vaginal or laparoscopic approach innapropriate
Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety

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)
Concealment ensured by research nurse allocating participants to intervention or comparison after assessment for eligibility in trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised with equal probability using a central computer-generated random allocation in blocks of 4-8. Subjects will be randomised in order of entry into the study by the research nurse
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
Intention to treat analysis

Outcomes were compared with Pearson chi squared test for categorical data and Student t test or Wilcoxon signed rank Test for continuous data as appropriate. 2 sided 95% confidence intervals will be used.

Pre-treatment & post-treatment changes in Quality of life questionnaires were analysed using repeated measures analysis of variance ANOVA or Friedman test as appropriate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/12/2021
Actual
Date of last participant enrolment
Anticipated
2/07/2024
Actual
Date of last data collection
Anticipated
3/07/2029
Actual
Sample size
Target
170
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 20001 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment hospital [2] 20002 0
Cabrini Brighton - Brighton
Recruitment postcode(s) [1] 34709 0
3165 - Bentleigh East
Recruitment postcode(s) [2] 34711 0
3186 - Brighton

Funding & Sponsors
Funding source category [1] 309129 0
Hospital
Name [1] 309129 0
Moorabbin Hospital, Monash Health
Country [1] 309129 0
Australia
Primary sponsor type
Individual
Name
Anna Rosamilia
Address
Moorabbin Hospital, Monash Health, Centre Road, Bentleigh East, Vic 3165
Country
Australia
Secondary sponsor category [1] 310080 0
None
Name [1] 310080 0
None
Address [1] 310080 0
none
Country [1] 310080 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309299 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 309299 0
Research Support Services
Level 2, iBlock,
Monash Medical Centre
246 Clayton Road,
CLAYTON VIC 3168
Ethics committee country [1] 309299 0
Australia
Date submitted for ethics approval [1] 309299 0
20/07/2021
Approval date [1] 309299 0
Ethics approval number [1] 309299 0

Summary
Brief summary
This project aims to determine the best surgical method of suspending the vagina after hysterectomy for pelvic organ prolapse. This will be measured by checking for symptomatic and objective recurrence of prolapse at multiple time points after the surgery.

Participants will include all those with symptomatic POP requesting hysterectomy as part of the surgical management for their symptoms. Patients will be recruited from public and private clinics and surgeries will be performed by gynaecologists or accredited trainees.

Participants will be randomised in equal probablity to a vaginal or laparoscopic approach for hysterectomy and the subsequent suspension of the vaginal vault (apex). There is a strict surgical protocol for surgeons to adhere to and patient will undergo subjective and objective assessment prior to surgery and then at several timepoints post surgery.

We expect to identify that both methods of vaginal suspension are equivalent based on the primary outcome
Trial website
Nil
Trial related presentations / publications
Nil
Public notes
Nil

Contacts
Principal investigator
Name 112594 0
A/Prof Anna Rosamilia
Address 112594 0
Moorabbin Hospital, Monash Health
823-865 Centre Road,
Bentleigh East, VIC 3165
Country 112594 0
Australia
Phone 112594 0
+61 3 9509 6500
Fax 112594 0
Email 112594 0
annarosamilia@urogyn.com.au
Contact person for public queries
Name 112595 0
Anna Rosamilia
Address 112595 0
Moorabbin Hospital, Monash Health
823-865 Centre Road,
Bentleigh East, VIC 3165
Country 112595 0
Australia
Phone 112595 0
+61 3 9509 6500
Fax 112595 0
Email 112595 0
annarosamilia@urogyn.com.au
Contact person for scientific queries
Name 112596 0
Anna Rosamilia
Address 112596 0
Moorabbin Hospital, Monash Health
823-865 Centre Road,
Bentleigh East, VIC 3165
Country 112596 0
Australia
Phone 112596 0
+61 3 9509 6500
Fax 112596 0
Email 112596 0
annarosamilia@urogyn.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not included in ethics request


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.