Trial Review

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] 296787 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
transvaginal mesh complication 310684 0
Condition category
Condition code
Reproductive Health and Childbirth 309383 309383 0 0
Other reproductive health and childbirth disorders
Renal and Urogenital 309384 309384 0 0
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] 313089 0
Diagnosis / Prognosis
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308340 0
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] 308340 0
pre-surgery
6 weeks after surgery
6 months after surgery (primary endpoint)
12 months after surgery
Secondary outcome [1] 354644 0
urinary incontinence using a 2 day bladder/urinary diary
Timepoint [1] 354644 0
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?
No
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
35
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 12632 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [2] 13036 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment hospital [3] 18770 0
Robina Hospital - Robina
Recruitment postcode(s) [1] 25055 0
4120 - Greenslopes
Recruitment postcode(s) [2] 25531 0
4108 - Coopers Plains
Recruitment postcode(s) [3] 33216 0
4226 - Robina

Funding & Sponsors
Funding source category [1] 301341 0
Self funded/Unfunded
Name [1] 301341 0
Prof Judith Goh
Country [1] 301341 0
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] 301008 0
None
Name [1] 301008 0
Address [1] 301008 0
Country [1] 301008 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302080 0
Greenslopes Ethics and Research Committee
Ethics committee address [1] 302080 0
Greenslopes Private Hospital
Newdegate St
Greenslopes QLD 4120
Ethics committee country [1] 302080 0
Australia
Date submitted for ethics approval [1] 302080 0
02/12/2018
Approval date [1] 302080 0
13/12/2018
Ethics approval number [1] 302080 0
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 89058 0
Prof Judith Goh
Address 89058 0
Suite 209 Ramsay Specialist Centre
Greenslopes Private Hospital
Newdegate St
Greenslopes QLD 4120
Country 89058 0
Australia
Phone 89058 0
+61 738479909
Fax 89058 0
+61 738476433
Email 89058 0
[email protected]
Contact person for public queries
Name 89059 0
Prof Judith Goh
Address 89059 0
Suite 209 Ramsay Specialist Centre
Greenslopes Private Hospital
Newdegate St
Greenslopes QLD 4120
Country 89059 0
Australia
Phone 89059 0
+61 738479909
Fax 89059 0
+61 738476433
Email 89059 0
[email protected]
Contact person for scientific queries
Name 89060 0
Prof Judith Goh
Address 89060 0
Suite 209 Ramsay Specialist Centre
Greenslopes Private Hospital
Newdegate St
Greenslopes QLD 4120
Country 89060 0
Australia
Phone 89060 0
+61 738479909
Fax 89060 0
+61 738476433
Email 89060 0
[email protected]

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




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.