Outcomes of surgery after removal of transvaginal mesh

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12619000582156

Enrollment

Registered

2019-04-15

Start date

2018-12-31

Completion date

2022-01-03

Last updated

2021-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Eligibility

Sex/Gender

All

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

None

Outcome results