ANZCTR - Registration

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.

With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12619000582156

Ethics application status

Approved

Date submitted

4/02/2019

Date registered

15/04/2019

Date last updated

19/02/2021

Date data sharing statement initially provided

15/04/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Outcomes of surgery after removal of transvaginal mesh

Scientific title

Follow up and outcomes of women after surgical removal of transvaginal mesh implant

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

transvaginal mesh complication

Condition category

Condition code

Reproductive Health and Childbirth

Other reproductive health and childbirth disorders

Renal and Urogenital

Other renal and urogenital disorders

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

review of patient symptoms following surgical removal of transvaginal mesh for prolapse and/or urinary incontinence. Review will be retrospectively from April 2018 with ongoing prospective recruitment and follow up.
Follow up of symptoms including pain, urinary symptoms and further treatment
at 6 weeks following surgery, 6 months and 12 months following surgery

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

no control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Before surgery, at 6 weeks, 6 months and 12 months, the following questions will be asked: Pain score with score of 0-10 (0 no pain, 10 worse pain) - Visual Analogue Score.

Timepoint [1]

pre-surgery 6 weeks after surgery 6 months after surgery (primary endpoint) 12 months after surgery

Secondary outcome [1]

urinary incontinence using a 2 day bladder/urinary diary

Timepoint [1]

pre-surgery - baseline 6 weeks after surgery 6 months after surgery 12 months after surgery

Eligibility

Key inclusion criteria

women who have had transvaginal mesh removed
women who consent to study

Minimum age

20 Years

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

None

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Both

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

31/12/2018

Date of last participant enrolment

Anticipated

3/01/2022

Actual

Date of last data collection

Anticipated

30/01/2023

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Greenslopes Private Hospital - Greenslopes

Recruitment hospital [2]

Queen Elizabeth II Jubilee Hospital - Coopers Plains

Recruitment hospital [3]

Robina Hospital - Robina

Recruitment postcode(s) [1]

4120 - Greenslopes

Recruitment postcode(s) [2]

4108 - Coopers Plains

Recruitment postcode(s) [3]

4226 - Robina

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Prof Judith Goh

Address [1]

Suite 209 Ramsay Specialist Center Greenslopes Private Hospital Newdegate St Greenslopes QLD 4120

Country [1]

Australia

Primary sponsor type

Individual

Name

Prof Judith Goh

Address

Suite 209 Ramsay Specialist Center
Greenslopes Private Hospital
Newdegate St
Greenslopes QLD 4120

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Greenslopes Ethics and Research Committee

Ethics committee address [1]

Greenslopes Private Hospital
Newdegate St
Greenslopes  QLD 4120

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/12/2018

Approval date [1]

13/12/2018

Ethics approval number [1]

Protocol 18/62

Summary

Brief summary

Transvaginal mesh for pelvic organ prolapse was approved for use in Australia in 2005. Since then, there have been complications and complaints which culminated in a Senate Inquiry. The Senate Inquiry reported back in March 2018. From January 2018, transvaginal prolapse mesh was withdrawan from use by the TGA in Australia. Mesh slings for urinary stress incontinence are still available in Australia.

Following the Senate Inquiry, the Australian Commission on Safety and Quality in Health Care (ACSQHC) provided information for consumers on treatment options for pelvic organ prolapse and urinary stress incontinence, guidance documents for care pathways and guidance documents for credentialing of specialists for mesh implant and removal.

The ACSQHC guidance document on mesh implant removal (attached) also recommended monitoring patient outcomes following surgical removal of mesh. Women with mesh complications, who elect and are suitable for mesh removal, will have a questionnaires (see attached) completed pre-operatively and at follow up visits. The questionnaires include symptomatology and visual analogue scores for pain.

The aims of this study are to review our surgical transvaginal mesh removal outcomes in women who have had substantial mesh removed (retrospectively and prospectively) and review our surgical techniques.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Judith Goh

Address

Suite 209 Ramsay Specialist Centre Greenslopes Private Hospital Newdegate St Greenslopes QLD 4120

Country

Australia

Phone

+61 738479909

Fax

+61 738476433

[email protected]

Contact person for public queries

Name

Judith Goh

Address

Suite 209 Ramsay Specialist Centre Greenslopes Private Hospital Newdegate St Greenslopes QLD 4120

Country

Australia

Phone

+61 738479909

Fax

+61 738476433

[email protected]

Contact person for scientific queries

Name

Judith Goh

Address

Suite 209 Ramsay Specialist Centre Greenslopes Private Hospital Newdegate St Greenslopes QLD 4120

Country

Australia

Phone

+61 738479909

Fax

+61 738476433

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

No
No IPD sharing reason/comment: Data will be analysed as a group and no individual data will be available for reporting or sharing

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
1292	Other				Australian Commission on Safety and Quality in Hea... [More Details]	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.

Trial Review

Documents added manually

Documents added automatically