To determine discontinuation and adverse event rates associated with medium-term pessary use for pelvic organ prolapse and/or stress urinary incontinence. Secondary objectives were to determine factors associated with adverse events, and to describe management and prognosis of those events.

Retrospective case series of women attending a nurse-run pessary clinic between 2015-2019. All women attending the clinic for pessary care during this time were included. Exclusions were 1. no baseline data available or 2. less than one year follow-up. Some patients were followed starting in 2012 with their physician, and data was collected until July 2020. Pessary fitting and re-fitting was performed by a urogynecologist. Trained nurses were responsible for pessary clinic visits which included pessary removal, cleaning and reinsertion +/- speculum exam. 

Demographics, comorbidities, pelvic floor symptoms, prolapse stage, and type of pessary fitted were collected at baseline. Follow-up information collected included re-fitting, adverse events (including vaginal bleeding, discharge, erosion, discomfort, pain, and urinary or vaginal infection), and discontinuation. Descriptive statistics are presented as N (%), mean (standard deviation) or median (interquartile range). Chi-square test was used to determine associations between various risk factors and discontinuation/pessary erosion rates. P less than 0.05 was considered significant. Sample size was based on a convenience sample of all patients that attended the clinic since inception. Post-hoc analysis reveals the study sample of n=238 will give us 80% power to detect a minimum difference between the 2 groups ranging from 17-20% for factors associated with discontinuation and pessary erosion rates; performing the Pearson chi-square test, 2-tailed test with 0.05 level of significance. Worst or best case scenarios depend on the proportion and the group size; worst case scenario have a proportion closer to 50% and/or unequal group size. SAS (University edition) was used for statistical analysis.

238 women were included. Mean age was 73.9 (9.0) years. Women were most commonly fitted with a ring with support [94 (39.8 %)] or Gellhorn [107 (45.3 %)] pessary at their initial visit. 107 (45 %) required a pessary refitting during subsequent visits. Most women presented for pessary care every 3-4 months. At a mean follow-up of 4.2 (2.1) years, 198 (83.2%) women continued using their pessary. Overall adverse event rate was 78.2%. Most common adverse events were vaginal discharge [76 (32.3%)] and vaginal bleeding [76 (33.3%)]. 101 (42.43%) women developed a pessary erosion, which recurred in 63.9% of cases. Erosions were most commonly treated with pessary vacation +/- vaginal estrogen use. Gellhorn pessary was associated with pessary erosion and discontinuation (p less than 0.001 and p=0.04 respectively). Age over 65 was associated with pessary erosion (p=0.01). 11 (4.6%) women had persistent/recurrent erosion at last included visit. Among women who discontinued pessary use, 18 opted for expectant management and 20 for surgery. Discontinuation occurred at a mean of 3.0 (1.9) years after initial fitting. Having a pessary erosion was not associated with discontinuation (p=0.89), but recurrent erosions were (p=0.02).

When comparing our findings to existing literature, we report findings of a longer follow-up than most published studies [1]. Definitions of adverse events vary between studies, which may explain our high adverse event rate [1]. One study of women using ring pessaries found a similarly high adverse event rate in the long-term (56%), although their discontinuation rate was also very high (86%) [2]. Inclusion criteria differed as we only included women who persisted with pessary use over 1 year. As such, our number of women with medium-term pessary use was very large, and we noted a high continuation rate despite these adverse effects. Many patients felt comfortable in continuing to use pessaries with follow-up and support from our nurse-led pessary clinic, despite the troubleshooting involved. Limitations include: 1. Some of the noted adverse events may not be directly attributed to pessary use, such as urinary tract infections and vaginal discharge, 2. Missing data was common, due to the study’s retrospective design.

Despite common adverse effects (78.2%) during a median of 4 years follow-up, continuation rate of pessary use was high (83.2%) among older women attending a nurse-led pessary clinic. Pessary erosions tended to recur in close to 2/3 women, and recurrence of erosion was associated with discontinuation.

Ko P.-C., Lo T.-S., Tseng L.-H., Lin Y.-H., Liang C.-C., & Lee S.-J. (2011). Use of a Pessary in Treatment of Pelvic Organ Prolapse: Quality of Life, Compliance, and Failure at 1-Year Follow-up. Journal of Minimally Invasive Gynecology, 18(1):68–74. doi: 10.1016/j.jmig.2010.09.006
Sarma S, Ying T, Moore KH. (2009). Long-term vaginal ring pessary use: discontinuation rates and adverse events. BJOG, 116(13):1715-21. Doi: 10.1111/j.1471-0528.2009.02380.x