ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12623001192673

Ethics application status

Approved

Date submitted

7/08/2023

Date registered

17/11/2023

Date last updated

17/11/2023

Date data sharing statement initially provided

17/11/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

A study comparing pelvic organ prolapse surgery in women with or without graft made from blood

Scientific title

Evaluating the surgical success rate of native tissue vaginal repair with or without autologous blood graft augmentation for pelvic organ prolapse: A randomised controlled trial

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pelvic organ prolapse

Condition category

Condition code

Renal and Urogenital

Other renal and urogenital disorders

Surgery

Other surgery

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intervention group: autologous graft
If a patient is randomised to "intervention group", she will undergo native tissue repair surgery [by two gynaecologists] with an autologous graft to augment the repair of the pelvic organ prolapse. Immediately before surgery, the experimental treatment involves drawing up 40mls of the patient's own blood for processing the autologous graft; this graft will be prepared in the operating theatre and produced at the time of surgery, which takes 40-60 minutes, and then be sutured or glued to the underlying connective tissue during prolapse repair surgery.

In the operating theatre room, the patient will be under a general anaesthesia during surgery. The conventional native tissue vaginal repair will be performed and then the autologous graft will be placed onto the prolapse repair site for augmentation. The vaginal skin is closed after this layer. At the completion of surgery, a vaginal pack and in-dwelling catheter will be placed until the next morning.

Adherence of intervention can be review of surgical record after the surgery and review of the patient and her records at each followup, at six weeks, six months, and 12 months.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Control group: conventional pelvic organ prolapse (POP) surgery
If a patient is randomised to "control group", they will undergo the conventional vaginal prolapse repair surgery [by two gynaecologists]. The surgery will be the same as intervention group, except that there is no graft created. At completion of surgery, a vaginal pack and in-dwelling catheter will be placed until the next morning.

In both groups, post-op care will be the same. Routine postoperative instructions will be provided regarding advice on physical activity progression, regular bowel habit, and abstinence of intercourse for 6wks. Patients will be discharged with an oral antibiotic if required. Follow-up will be at one week which is tele-consult and face-to-face at 6 weeks, 6 months, and 12 months.

Control group

Active

Outcomes

Primary outcome [1]

The primary outcome is the anatomical success rate of pelvic organ prolapse at one-year post-op, based on the change from baseline in pelvic organ prolapse quantification (POPQ) staging and at the 12-month follow-up visit. Success is defined as a decrease of 1 or more in POPQ stage at 12 months from baseline, with no reoperation for anterior and posterior vaginal wall prolapse. Participants with either no change in POPQ from baseline, or an increase, will be designated as failures.

Timepoint [1]

12-month post-op follow-up visit

Secondary outcome [1]

Quality of Life (QOL) as assessed by total score of the Australian pelvic floor questionnaire (APFQ), which is a validated tool that integrates bladder, bowel, prolapse, and sexual function. Higher scores in each domain suggest greater QOL impairment. Patients will be asked to fill out APFQ questionnaires at baseline and each follow-up visit.

Timepoint [1]

at 6 weeks, 6 months, and 12 months post-op.

Secondary outcome [2]

Minor and major complication rates, infection, severe bleeding (blood loss of 500mls), urinary tract infection, wound breakdown, graft rejection, unplanned return to theatre, urinary retention treated with catheter, visceral injury, venous thromboembolism and pulmonary embolism. These will be assessed as a composite outcome. This will be assess by clinician review, Australian Pelvic Floor Questionnaire (APFQ), review of patient medical record

Timepoint [2]

Post-op, 6 weeks, 6 months, and 12 months postop

Secondary outcome [3]

Pain score postop by pain visual analogue scale and need for analgesia will be compared in both groups.

Timepoint [3]

Post-op (within 24 hours post-surgery)

Secondary outcome [4]

pain score by visual analogue scale by review of medical records

Timepoint [4]

at baseline, 6 weeks, 6 months, 12 months post-op

Secondary outcome [5]

need for analgesia by review of medical records

Timepoint [5]

at baseline, 6 weeks, 6 months, 12 months postop

Eligibility

Key inclusion criteria

Participants will be considered eligible for this study if they:

1. Are female patients over the age of 18
2. Have been formally diagnosed with pelvic organ prolapse quantification (POPQ) stage 2 of anterior and or posterior compartment with or without apical prolapse, defined as c -1 (cervix or vaginal cuff 1 cm above hymen) or less.
3. Understand the conditions of the study fully and are willing to participate for the length of the study in its entirety;
4. Are capable of giving informed consent to their participation in the study.

Minimum age

19 Years

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

The following patients will be deemed unsuitable for inclusion:

Patients currently suffering any untreated gynaecological cancers.
Patients with autoimmune disorders requiring anti-platelet medication (antiplatelet drugs weaken the regenerative capacity of autologous blood products and reduces the quality of the graft)
Patients who are immunocompromised (e.g. lymphoma, AIDS) or have uncontrolled malignant disease.
Patients on anti-platelet treatment. Using anticoagulants and NSAIDs is not allowed three weeks before and after surgery due to their interference with the scaffold formation.
Patients who have a mental disability leading to their inability to consent.
Patients who are pregnant.
Patients who are uncooperative, known to miss appointments, are unlikely to follow medical instructions, or unable to attend regular scheduled visits.

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)

Sealed opaque envelopes.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 2

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

A statistical analysis plan will be prepared prior to data lock.

In general:
A p-value of 0.05 is selected to assess statistical significance.
Means and standard deviations (SD’s) will be calculated for continuous data
Proportions will be calculated for categorical data.
Missing data will not be imputed.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/12/2023

Actual

Date of last participant enrolment

Anticipated

30/04/2025

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

298

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Ashford Community Hospital - Ashford

Recruitment hospital [2]

North Eastern Community Hospital Inc - Campbelltown

Recruitment postcode(s) [1]

5035 - Ashford

Recruitment postcode(s) [2]

5074 - Campbelltown

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Smartfem Medical Technology Pty Ltd

Address [1]

46 Marleston Ave, Ashford, SA, 5035

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

FBW Gynaecology Plus

Address [2]

46 Marleston Ave, Ashford, SA, 5035

Country [2]

Australia

Primary sponsor type

Commercial sector/Industry

Name

FBW Gynaecology Plus

Address

46 Marleston Ave, Ashford, SA, 5035

Country

Australia

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Smartfem Medical Technology Pty Ltd

Address [1]

46 Marleston Ave, Ashford, SA, 5035

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bellberry Human Research Ethics Committee

Ethics committee address [1]

123 Glen Osmond Road Eastwood AdelaideSouth Australia 5063

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/11/2022

Approval date [1]

19/09/2023

Ethics approval number [1]

2022-11-1211

Summary

Brief summary

Pelvic organ prolapse (POP) is a common gynaecological condition with an incidence of 40-60%, and 12-19% of women undergo surgical correction. Standard technique of native tissue repair (NTR) relying on damaged tissue is associated with variable success and recurrence rate up to 30-50% initiating the exploration of innovative surgical techniques and grafts to improve long-term outcomes. Surgery is preferential for younger women with more severe symptoms related to quality of life, if also affecting bladder, bowel, and sexual function. Use of transvaginal polypropylene mesh is no longer accepted in most of the global market due to unfavourable complications of increased reoperation rates, mesh erosion, dyspareunia, and chronic pelvic pain. Surgical techniques using biological grafts or absorbable mesh to augment POP have been trialled, with systematic reviews based on low quality evidence demonstrating minimal advantage compared with NTR regarding rates of awareness of prolapse or reoperation. Low to moderate quality evidence suggests higher recurrence rates for anterior prolapse after NTR than with biological grafts. 

 This is a randomised controlled trial comparing two surgical approaches for pelvic organ prolapse treatment: Intervention Group with autologous graft augmentation and Control Group with conventional prolapse repair surgery. In Group 1, patients undergo native tissue repair surgery for vaginal prolapse, with an autologous graft prepared from 40mls of the patient's own blood during surgery. The graft is then sutured or glued to the underlying connective tissue. In Group 2, patients undergo the same surgery as Group 1 but without the creation of a graft.

Postoperative care is identical for both groups, including routine instructions on physical activity, bowel habits, and abstinence from intercourse for six weeks. Patients are followed up teleconsult at one week and face-to-face at 6 weeks, 6 months, and 12 months.

Participants are invited to the study after being diagnosed with pelvic organ prolapse that requires pelvic floor repair surgery, having tried medications and non-surgical alternatives with persistent symptoms. The study includes an initial assessment consultation, surgery, and three follow-up assessments at 6 weeks, 6 months, and 12 months after the treatment.

No medical expenses are incurred during these consultations or treatments, and both specialists involved in patient care will be responsible for administering the study treatment and performing the assessments. The assessment consultations involve evaluating the pelvic organ prolapse, bowel, bladder, and sexual function to determine the treatment's effectiveness.

This study aims to provide valuable insights into the efficacy of autologous graft augmentation compared to conventional prolapse repair surgery, contributing to improved treatment options for patients suffering from pelvic organ prolapse.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Tran Nguyen

Address

FBW Gynaecology Plus 46 Marleston Avenue Ashford SA 5035

Country

Australia

Phone

+61 8 8297 2822

Fax

tran.nguyen2@sa.gov.au

Contact person for public queries

Name

Tran Nguyen

Address

FBW Gynaecology Plus 46 Marleston Avenue Ashford SA 5035

Country

Australia

Phone

+61 8 8297 2822

Fax

tran.nguyen2@sa.gov.au

Contact person for scientific queries

Name

Tran Nguyen

Address

FBW Gynaecology Plus 46 Marleston Avenue Ashford SA 5035

Country

Australia

Phone

+61 8 8297 2822

Fax

tran.nguyen2@sa.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
19776	Informed consent form					386276-(Uploaded-21-07-2023-15-07-16)-Study-related document.pdf
19777	Study protocol					386276-(Uploaded-25-09-2023-19-14-52)-Study-related document.docx

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.

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