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Trial registered on ANZCTR


Registration number
ACTRN12622001018707
Ethics application status
Approved
Date submitted
14/02/2022
Date registered
20/07/2022
Date last updated
20/07/2022
Date data sharing statement initially provided
20/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Post-operative pessary in prolapse surgery and its impact on recurrent prolapse
Scientific title
Examining the effect of a Post-Operative Pessary In native Tissue repair for adults with pelvic organ prolapse: a prospective, single blinded randomised controlled trial
Secondary ID [1] 306423 0
None
Universal Trial Number (UTN)
Trial acronym
POP IT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
vaginal prolapse 325257 0
Condition category
Condition code
Renal and Urogenital 322656 322656 0 0
Other renal and urogenital disorders
Surgery 322657 322657 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A vaginal pessary device is a removable device made of silicone. It is normally inserted into the vagina by a gynaecologist to support the prolapsed walls of the vagina and/or uterus. However, the indication in this instance is to take tension away from the native tissue and suture lines post operatively (if randomised to treatment group) which may improve tissue regeneration and healing which could lead to better surgical results and patient satisfaction.

There are various sorts of pessaries available. However for this study, we have opted to use a Shaatz type pessary as it is the most applicable for keeping tension off the native tissue while providing extra support to the vagina as it heals from the surgery.

Participants if enrolled into the study, would need to fill in a pre-operative questionnaire and post-operative questionnaire. All participants would receive their surgery which would be routine surgery with or without the study. The patients enrolled into the treatment arm would at the end of surgery have the vaginal pessary inserted by the surgeon (which would take an additional 2 minutes) while still under general anaesthesia to minimise discomfort.

The total duration of device use is 4 weeks post-surgery and will be removed by Prof Rane at the time for the 4 week post operative review.

The associate investigator (urogynaecology fellow) will be doing the pre and post surgery vaginal assessment without being aware of which treatment arm the patient is in so as to have an objective vaginal assessment.

Further follow up in the outpatient clinic would be at 3 and 6 months post operative as well.
Intervention code [1] 322860 0
Treatment: Devices
Comparator / control treatment
No vaginal pessary device at the end of vaginal prolapse surgery
Control group
Active

Outcomes
Primary outcome [1] 330454 0
Success in anterior compartment at 6 months post operation

Success is defined as a composite of objective findings and subjective patient report.

Objective anatomic success is defined as anterior prolapse no greater than Stage 1 (reference point Ba < -1cm on Pelvic Organ Prolapse Quantifications System (POP Q) examination.

Subjective success as defined as absence of “bulge” symptom based on the PDFI-20 validated questionnaire.

Failure will be defined as leading edge of anterior vaginal wall a Stage 2 or more (reference point Ba >= -1cm) or presence of “vaginal bulge” symptom on validated questionnaire.
Timepoint [1] 330454 0
6 months post operative
Secondary outcome [1] 406278 0
Change in POPQ quantitative measurements from baseline at 6 months post operation
Timepoint [1] 406278 0
6 months post operative
Secondary outcome [2] 411960 0
Anatomic success of any associated posterior repair procedure. Objective anatomic success as posterior prolapse no greater than Stage 1 (reference point Bp < -1cm) on Pelvic Organ Prolapse Quantifications System (POP Q) examination
Timepoint [2] 411960 0
6 months post operative
Secondary outcome [3] 411961 0
Anatomic success of any associated apical repair procedure at 6 months post operation. Objective anatomic success as apical prolapse no greater than Stage 1 (reference point C < -1cm) on POPQ examination
Timepoint [3] 411961 0
6 months post operative
Secondary outcome [4] 411962 0
Any change in Ten point Patient Global Assessment of Change (PGA-C) visual analogue scale 4 weeks post operation
Timepoint [4] 411962 0
4 weeks post operative
Secondary outcome [5] 411963 0
Any change in Ten point Patient Global Assessment of Change (PGA-C) visual analogue scale 3 months post operation
Timepoint [5] 411963 0
3 months post operative
Secondary outcome [6] 411964 0
Any change in Ten point Patient Global Assessment of Change (PGA-C) visual analogue scale 6 months post operation
Timepoint [6] 411964 0
6 months post operative
Secondary outcome [7] 411965 0
Complications of surgery as per Clavien-Dindo Classification (Appendix A) - as referenced in attached protocol document.
Complications data will be sourced from patient operation reports, hospital progress notes discharge summaries and note of re-admission to hospital.
Timepoint [7] 411965 0
6 months post operative

Eligibility
Key inclusion criteria
- Women (18 years and over) with symptomatic pelvic organ prolapse requiring an anterior vaginal repair (level 1 or level 2) at our facility
- Medically fit for surgery
- Able to complete the questionnaire independently with reasonable level of English and English is their first language
- Patients that have not been recommended surgery that involves colpocleisis, mesh or other surgical approach (such as laparoscopy or laparotomy)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Asymptomatic pelvic organ prolapse
- Refusal to participate
- Women of non-English speaking background

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation generation via REDcap
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2022
Actual
Date of last participant enrolment
Anticipated
1/08/2023
Actual
Date of last data collection
Anticipated
1/03/2024
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 21726 0
Mater Hospital Pimlico - Pimlico
Recruitment postcode(s) [1] 36777 0
4810 - Pimlico

Funding & Sponsors
Funding source category [1] 310772 0
Self funded/Unfunded
Name [1] 310772 0
Country [1] 310772 0
Primary sponsor type
Hospital
Name
Mater Hospital - Pimlico
Address
21/37 Fulham Road, Pimlico, QLD 4812
Country
Australia
Secondary sponsor category [1] 312010 0
None
Name [1] 312010 0
None
Address [1] 312010 0
None
Country [1] 312010 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310347 0
Mater Misericordiae Ltd Human Research Ethics Committee
Ethics committee address [1] 310347 0
Mater Misericordiae Ltd
Raymond Terrace, South Brisbane
QLD 4101
Ethics committee country [1] 310347 0
Australia
Date submitted for ethics approval [1] 310347 0
18/05/2021
Approval date [1] 310347 0
06/12/2021
Ethics approval number [1] 310347 0
HREC/MML/75934 (V4)

Summary
Brief summary
Vaginal prolapse is a common problem with approximately 1 in 10 women in the developed world requiring prolapse surgery in their lifetime . The problem has a myriad of symptoms ranging from mild discomfort to being very problematic and having a huge impact on quality of life.
Surgery is generally seen as a last resort for managing vaginal prolapse, especially if a conservative method has been tried (eg: vaginal pessary device). However, the results of surgery alone are not perfect, and some women will develop recurrent prolapse or not be satisfied with the result.
The thought of having a vaginal pessary device inserted at the end of the operation is for the pessary device to take tension away from the native tissue and suture lines and hence improve tissue regeneration, healing without scarring, leading to better surgical results and patient satisfaction.
This could revolutionize the way we manage our level 1 and level 2 repairs and may result in better surgical outcomes, lower prolapse recurrence and better quality of life for our women in the long term.

This study is to determine if having a vaginal pessary device (shaatz pessary) inserted intraoperatively at the end of vaginal prolapse surgery temporarily for 4 weeks will improve surgical results and patient satisfaction.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117326 0
Dr Amanda Wee
Address 117326 0
Mater Pelvic Health
21-37 Fulham Road, Pimlico QLD 4812
Country 117326 0
Australia
Phone 117326 0
+61747274097
Fax 117326 0
Email 117326 0
amanda.wee@health.qld.gov.au
Contact person for public queries
Name 117327 0
Prof Ajay Rane
Address 117327 0
Mater Pelvic Health
21-37 Fulham Road, Pimlico QLD 4812
Country 117327 0
Australia
Phone 117327 0
+61747274097
Fax 117327 0
Email 117327 0
ajay.rane@jcu.edu.au
Contact person for scientific queries
Name 117328 0
Prof Ajay Rane
Address 117328 0
Mater Pelvic Health
21-37 Fulham Road, Pimlico QLD 4812
Country 117328 0
Australia
Phone 117328 0
+61747274097
Fax 117328 0
Email 117328 0
ajay.rane@jcu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15082Study protocol    383567-(Uploaded-14-02-2022-18-00-57)-Study-related document.docx
15083Ethical approval    383567-(Uploaded-14-02-2022-18-03-13)-Study-related document.pdf



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.