The impact on complication rates of delayed routine pessary reviews during the COVID-19 pandemic

Abstract

Introduction and hypothesis During the COVID-19 pandemic, guidance was issued in the United Kingdom advising a delay in routine pessary reviews. The impact of this has not been fully explored. The null hypothesis for this study is that delayed routine pessary reviews during the COVID-19 pandemic did not result in a statistically significant increase in complication rate. Methods A retrospective comparative cohort study was conducted in NHS Tayside, Scotland, involving 150 patients pre-pandemic and 150 patients during the COVID-19 pandemic (before exclusions). Their notes were reviewed identifying age, care provider, pessary type, length of pessary usage, review date, time elapsed since the previous review, bleeding/infection/ulceration, removal issues, pessary replacement and outcome. Patients excluded were those with no pessary in situ at review, reviews at ≤4 months and >8 months (pre-pandemic) and reviews at ≤8 months (COVID-19 pandemic). Results The pre-pandemic group ( n =106) had average review times of 10.1,6.2 and 6.2 months for cubes, rings and all others. Overall rates of bleeding/infection/ulceration; reported removal issues; and pessary subsequently not replaced were 9.4%, 11.3% and 5.7% respectively. The COVID-19 pandemic group ( n =125) had average review times of 14.7, 10.8 and 11.4 months for cubes, rings and all others. Overall rates of bleeding/infection/ulceration; reported removal issues; and pessary subsequently not replaced were 21.6%, 16.0%, and 12.0% respectively. Conclusions Overall, there was a significant increase in rates of bleeding/ulceration/infection ( p =0.01). When individual pessaries were considered, this only remained true for rings ( p =0.02). Our data would suggest that routine ring pessary reviews should not be extended beyond 6 months or risk bleeding/ulceration/infection.

A randomized controlled study comparing the objective efficacy and safety of a novel self-inserted disposable vaginal prolapse device and existing ring pessaries

“…The aim of this post-hoc analysis of data from a randomized controlled trial was to demonstrate the substantial objective efficacy and safety of ProVate in the non-surgical management of POP and compare it to the efficacy and safety of a commercially available ring pessary (the control). ProVate and the control reduce POP in the same manner (provide mechanical support); yet, ProVate has the following upsides: it is an all-disposable device, can be self-inserted and removed by the user, can be used anywhere, and at any time, has small dimensions, exists within an applicator, and comes with no dependency on the clinic (other than routine checkups); thus, it is expected to improve user’s experience and substantially reduce the discontinuation rate ( 25 ) while enabling unhindered pessary usage even during times of inability to attend the clinic for ongoing pessary replacement [e.g., frailness, exacerbations of severe illnesses, pandemics ( 26 , 27 ), etc. ], which may increase the incidence of AEs.…”