Pessary-related complications: a brief overview

Pelvic floor disorders (PFD) are a common health problem, with a prevalence reaching up to 25% of women in the United States. The demand for care for this problem has been reported to increase dramatically by 35% by 2030 (1,2). Some researchers suggest that PFD may be underestimated and may affect 50% of healthy, non-pregnant women for pelvic organ prolapse (POP), and 30% for stress urinary incontinence (SUI) (3,4). Most clinical symptoms such as POP, SUI, and fecal incontinence can be treated surgically or conservatively by the application of different types and shapes of vaginal pessaries (5). Furthermore, vaginal pessaries were considered a first-line treatment for non-surgical management of women affected by POP/SUI who do not desire operation due to various reasons (6,7). The American Urogynecologic Society (AUGS) and the Society of Urologic Nurses and Associates (SUNA) have discovered that, despite common application of vaginal pessaries, only four high-quality manuscripts have been published so far, reporting their efficacy and complications (8).

We are pleased to provide commentary of the manuscript by Omosigho et al. entitled “Outcomes in Women With Pelvic Organ Prolapse Presenting With Pessary-Related Complications”, published in the journal Urogynecology (Phila) (9). This retrospective cohort study, approved by the review board, analyzed records of 2,088 patients who were managed with vaginal pessary for at least a year, and of these women, 444 patients experienced pessary complications. The authors defined two objectives of their research; first, the nature and management of complications associated with pessary application in women receiving conservative management of POP/UI, and the second, the characteristics of women presenting with pessary complications. Moreover, the identification of factors associated with the decision to proceed with surgical intervention was also performed. In general, pessary fitting was commonly used by white, postmenopausal patients with diabetes mellitus who also received vaginal estrogen therapy. This study identified common comorbidities in these patients, which can help clinicians prepare for appropriate management. Ring with support was the most commonly applied pessary subtype, along with ring without support, cube, donut, incontinence dish and other typical equipment available all over the world.

The complications rate presented in this study, after more than one year of pessary application, was relatively low (21%) compared to other studies. For example, Lone et al. (2011) reported a rate of 43%, and Sarma et al. (2009) reported a rate of 53% (10,11). However, Moore et al. (12) presented even lower rate of adverse events rate with pessary therapy (12%) compared to the rate presented herein. Moreover, they suggested that monthly self-management of vaginal ring pessaries can reduce the rate of complications (12). The most common complications found in the article were expulsion (40.8%) and pain (26.6%). Abdulaziz et al. (13) reported that superficial vaginal mucosal erosion with such symptoms as vaginal discharge, bleeding, and even nasty vaginal odor, was the most frequently adverse event. They reported also that all five Clavien-Dindo grades of complication occurred as a consequence of pessary fitting, and their severity depended on the duration of pessary use (13).

Short time (up to a year) of follow-up may explain the absence of organ fistulas in the results presented by Omosigho et al. (9). Additionally, the authors acknowledged the possibility of underestimating the incidence of complications if they were not documented correctly. A clinically significant finding was the association between long-term anticoagulant application [odds ratio (OR), 2.80; 95% confidence interval (CI): 1.05–7.41] and the lack of vaginal estrogen usage (OR, 1.73; 95% CI: 1.06–2.80), with more than one pessary-related complication. Another interesting result they found out was the incidence of de novo SUI after proper pessary administration, which was 7.4% (33 patients out of 444) and, unfortunately, may have been underestimated. Global data indicate that vaginal prolapse may be accompanied by SUI. Nearly 55% of women with stage 2 POP have concurrent SUI, while only 33% of women with stage 4 POP developed SUI, probably due to urethral kinking (14). Interestingly, when prolapse is reduced digitally, or during speculum examination or even with vaginal pessary fitting, up to 68% of women might demonstrate “occult” SUI. A limited number of continent women may also develop clinical symptoms of de novo SUI post-operatively (15). Therefore, the three main subtypes of SUI—accompanying vaginal prolapse, “occult” SUI and de novo SUI, may altogether present a higher percentage than reported in this study.

Finally, surgical intervention was needed in 34.2% (152 out of 444) of patients who developed at least one complication during more than a year of pessary use. This percentage is consistent with data presented by Meister et al. (16), where almost one-third of patients underwent surgery for POP within 7 years of pessary fitting. Although vaginal pessaries have been commonly documented for more than 50 years, there is still a lack of critical standards of care (placement strategies, routine maintenance, management of pessary-related complications) (6,7,17). Some severe complications may occur during pessary fitting in obstetrics care as previously documented by our group (18). Based on the type of complications occurred during short-term pessary use, recommendations presented by AUGS and SUNA become even more attractive (17).

In conclusion, it is worth citing the one of the last sentences of Omosigho’s study (9), which stated that “Pessaries are a valuable treatment option for POP and UI, especially in patients who are not candidates or do not desire surgical management of POP and UI”. It will be of utmost interest in future studies to compare the complications of pessary fitting in different groups (patients who refuse surgical intervention vs. women with surgical contraindications). Long-term follow-up observation from world-renowned Institutions will be truly important for searching the factors associated with pessary-associated complications.

Acknowledgments

Funding: None.

Footnote

Provenance and Peer Review: This article was commissioned by the editorial office, Gynecology and Pelvic Medicine. The article has undergone external peer review.

Peer Review File: Available at https://gpm.amegroups.com/article/view/10.21037/gpm-23-58/prf

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://gpm.amegroups.com/article/view/10.21037/gpm-23-58/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

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