APFPR 2023 Annual Report

The APFPR is pleased to release the APFPR 2023 Annual Report. Please click on the link to download it. APFPR 2023 Annual Report

KEY HIGHLIGHTS

The APFPR is a clinician-led, consumer-centred national Clinical Quality Registry (CQR) managed by Monash University, established in 2019, following a 2018 Senate Inquiry into the use of pelvic mesh.

• The APFPR is supported by funding from the Australian Government, Department of Health and Aged Care, under the National Clinical Quality Registry Program
• Almost 1 in 2 Australian women are affected by pelvic floor disorders including Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP)
• The Data presented, with the exception of number of patients and participating hospitals, data relates to the period up to 29th September 2023
• 40 hospitals are currently participating across 7 jurisdictions: New South Wales, Victoria, Western Australia, Tasmania, Queensland, Australian Capital Territory, South Australia.  Public and private hospitals are included
• Consumers are represented on the Steering Committee and via a Consumer advisory group
• The Clinical Advisory Committee includes specialists from four craft groups that conduct pelvic floor procedures: urologists, general gynaecologists, urogynaecologists and colorectal surgeons
• 937 patients were recruited into the registry (as at February 2023)
• Patient opt-out rates remain low, at less than 3%
• The APFPR captures outcome data in relation to:

• • Stress Urinary Incontinence (SUI) Procedures
    • Mid urethral Sling (synthetic mesh)
    • Bulking agent injections
    • Bulking agent removal
    • SUI mesh revision/explantation
    • Autologous Fascial sling (*From February 2024)
    • Burch Colposuspension (*From February 2024)
  • Pelvic Organ Prolapse (POP) Procedures
    • Sacrocolpopexy with mesh
    • Sacrohysteropexy with mesh
    • Anterior/Posterior repair with mesh
    • POP mesh revision/explantation

About Pelvic Floor Procedures

For the first time, the Annual Report presents analysis on the safety and efficacy of pelvic floor procedures, with analysis based on clinical data reported by clinicians, and Patient Reported Outcome Data (PROMs), which is reported by patients themselves. The annual report captures data for procedures on 436 women* (322/78% relate to SUI procedures). *As at 26^th September 2023

SUI Procedures (n=322)

• Procedures included
  • mesh slings (177 procedures)
  • bulking agents (98 procedures)
  • revision/management of complications (47 procedures)
• The median age of patients having the above-mentioned procedures was 60, 64, and 59 years respectively
• 90% of mesh sling, and 74% of bulking agent procedures reported positive outcomes with few complications, as captured at the first post-operative visit (at approximately 6 weeks)
• Nearly 80% of SUI mesh procedures used Gynaecare TVT Exact Mesh.

POP Procedures (n=47)

• All women experienced improved POP status, as recorded at the first post-operative visit
• Median age of women having these procedures was 68 years, with >90% being post-menopausal
• 49% had voiding dysfunction at clinical assessment

SUI+POP (n= 35)

• Over 90% of women reported an improvement at their first post-operative follow up visit
• The POP + SUI cohort had a median age of 65 years.
• 14% had dyspareunia at clinical assessment

Mesh Explantation (A subset of SUI procedure data; n=26)

• For the first time, the APFPR is presenting very early registry data regarding mesh removal procedures. The APFPR acknowledges that this is very early data and may change as it matures, however it is of great importance to consumers
• The most common indication for mesh removal was pain (37.1%), followed by mesh exposure (34.3%) and voiding dysfunction (11.4%)
• Over 50% of all presenting indications had been resolved or had improved at the first post-operative visit

Clinical Quality Indicators

CQIs are measure of performance, that capture how well the care provided aligns with best practice (Process measures) as well as the clinical outcomes obtained (Outcome measures). Clinical quality indicators are based on recommendations made by the Australian Commission on Safety and Quality in Health Care

• Regarding the process indicators, most primary participants underwent objective clinical assessment (90% and 92% for SUI and POP, respectively)
• Intra-operative cystoscopy was performed in almost all women who underwent primary[1] procedures (99% and 100% respectively)
• Efficacy was high for both SUI and POP procedures, with 84% of primary SUI participants and 96% of primary POP/ SUI+POP participants reporting improvement
• Of the surgical complications, readmission within 30 days and discharged requiring catheterisation for primary procedures were the most common, but still infrequent (4% and 5%, respectively)
• Return to theatre was very rare for primary and subsequent¹ procedures (<1%)

Patient Reported Outcome Measures (PROMs)

• The APFPR collects outcome information directly from women (PROMs) at 6, 12 and 24 months post-surgery
• The information includes specific questions from the Australian Pelvic Floor Questionnaire as well as more general questions regarding quality of life and overall improvement
• Initial PROMs undertaken by the registry showed an overall clinically significant improvement post-surgery

[1] The APFPR reports whether a procedure is a primary (first of its kind) or a subsequent procedure, which may be a revision or a procedure to manage a complication or adverse outcome of a primary procedure.

APFPR 2023 Annual Report