Hypothesis / aims of study
This systematic review has three key aims:
Firstly, to consolidate all known and published cases of fistulation arising from vaginal pessary use in the treatment of pelvic organ prolapse(POP) and female urinary incontinence in a summarised table to contribute to the current body of knowledge and enable convenient citation and referencing for future studies.
Secondly, it aims to analyse and elucidate risk factors for fistula complications, both known and novel, in terms of patient demographics, initial presentation with symptoms, clinical course of disease, duration of pessary use and treatment compliance.
Lastly, it seeks to contribute to the current database of fistulation occurring from pessary use by presenting two unpublished case that have been detected at a tertiary hospital’s urogynaecology service within the past two years with one case exploring a rare possible instance of adverse drug event that was suggestive of a novel association between fistulation and use of that class of medication.
Study design, materials and methods
A systematic review was conducted via PubMed, EMBASE, Scopus, Web of Science, and CINAHL respecting Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The following free terms were used on all databases: “pessary” OR “pessaries”, AND “fistula” OR “fistulas” OR “fistulation” OR “fistulating”. All publications from 1961 till 23rd January 2024 were retrieved. Citations of case series and reviews were hand-searched to allow identification of additional publications that may have been missed in previous searches to ensure capture of all relevant information. The inclusion criteria consisted of clinical cases or case series of serious complications from vaginal pessary use in female patients that were written in the English language and had an accessible abstract. The exclusion criteria consisted of male patients, publications not in English, cases that dealt with pregnancy or fertility related issues, fistulation without a prior history of pessary use and pessaries use of treatment of conditions other than POP or urinary incontinence.
Articles were screened on the basis of their titles and abstracts with the following information was extracted: title, author, year, journal, number of cases, age, clinical evolution, the initial presentation of symptoms, vaginal symptoms, vaginal entrapment or incarceration, presence of fistula, pelvic infection, urologic symptoms or any extragenital symptoms, examination findings, diagnosis delay, type of treatment, outcome, month of pessary insertion, total time of pessary use, and patient status.
In terms of definitions, duration of pessary insertion was measured in months from insertion till symptom presentation while total time of pessary use was measured in years. Pessary neglect was when a pessary was left in-situ for an extended length of time without proper follow-up. Incarceration of pessary was defined as pessary entrapment due to vaginal adhesions. Vesicovaginal and rectovaginal fistulas were defined as an abnormal communication of the vaginal epithelium with the bladder or rectum epithelium respectively.
Results
A total of 1902 abstracts and full text articles were identified where after screening and reviewing, 55 studies met the inclusion criteria totaling 75 patients.
The average age of published patients was 78.7 years with median 81, range 48 and standard deviation 10.7. The average time from the last pessary change was 60.7 months while the average total time of pessary usage was 11.4 years. The most frequent minor complication experienced by 61 patients (81.3%) was vaginal symptoms with 27 patients reporting discharge and 17 reporting bleeding. The most frequent major complications were fistulas experienced by 43 patients, either VVF or RVF, and incarceration of the pessary experienced by 20. Regarding the care and follow-up of the patients, 48 (64.0%) were neglected, 25 (33.3%) were not neglected, and data could not be obtained for 2 patients (2.3%).
Interpretation of results
This review reports that most complications occurred with ring and Gellhorn pessaries but did not suggest an association with a specific adverse outcome. Furthermore, given that these two types of pessaries are the most commonly utilized internationally, their prevalence may confound the associated with complications wherein fact their rate of complications are low.
Similarly, the review suggests older patients experienced complications more often given the mean age of 78.7 years whereas the association could be partly explained by firstly patients symptomatic from POP to be in their 6th and 7th decade of life which would lead to more patients seeking treatment in that age group compared to younger patients. Furthermore, these patients may also be more likely to opt for non-surgical management of POP due to either a self-perceived or clinically assessed non-fitness for surgery due to co-morbidities. These may themselves also increase their risk of complications from pessary use due to reduce mobility, poor healing or reduced immunity. These factors may have led to a large proportion of older patients to be on pessaries while younger and medically fit patients may have opted for surgical management. Lastly, there may have been an increased duration of risk exposure for older patients who have been on the pessary for a longer period of time who are then more likely to experience complications as reported in this review as well as previous reviews.
The importance of regular follow-up was emphasized through this review given the association of neglect with complications (60%) however closer follow-up may not necessarily dictate better outcomes. Therefore, even with appropriate fitting and regular review, complications may still occur emphasizing the need for realistic patient counselling. However, with this study reporting 45 of out the 75 cases having neglect, this factor cannot be ignored where compliance to follow-up should also be included during counselling of patients for vaginal pessaries to reduce complication risk.
The strength of this study was that it comprehensively retrieved and analyzed all known publications from a large number of databases on fistulations caused by vaginal pessary use up until January 2024 with its findings positioned to be an authoritative source of information.
The limitations of this review are that firstly it relied on published literature which may not capture the true prevalence of complications from vaginal pessaries due to underreporting, misdiagnosis and exclusion of articles not in the English language. Secondly, recall bias may be present given a higher probability of recalling negative experiences post-diagnosis that may affect data on initial presentation of symptoms and duration of pessary use. Lastly, given the large scope spanning decades and inclusion of articles from different databases, heterogeneity of publications was unavoidable with different definitions utilised in terms of diagnosis and timelines as well as missing information that was required for greater insight. While best attempts were made to standardize information and exclude non-contributory data, data integrity may still have been affected which supports the call for a universal standard on literature concerning fistulas caused by vaginal pessaries.
Concluding message
POP affects a substantial percentage of women, necessitating effective and safe treatment options. Vaginal pessaries have emerged as a non-surgical alternative, mitigating the financial and health burdens associated with POP surgery. While generally considered low-risk, pessaries are not without complications, ranging from minor side effects to severe outcomes such as erosions and fistulations therefore their associated complications demand ongoing scrutiny. Healthcare providers must balance the benefits and risks judiciously, considering patient-specific factors. The study calls for enhanced awareness, standardized reporting, and future research to establish a more robust understanding of the true risks associated with pessary use, ensuring optimal patient safety and informed decision-making in clinical practice.