The Use of Vaginal Pessary for Pelvic Organ Prolapse’s Treatment

Pelvic organ prolapse (POP) is the descent of the anterior and/or posterior vaginal wall or vagina apex (uterus or vaginal apex after a hysterectomy) and has negative effects on woman’s daily activities and reduces her quality of life. One of the treatments of POP is pessary that has limited evidence but still commonly used for treatment of genital prolapse and considered as the first line treatment by the American Urogynecologic Society (AUGS). This evidence-based case report (EBCR) is made to critically analyze from the current studies whether the use of pessary improves the symptoms of pelvic organ prolapse or not. A search of literature was performed in two databases, MEDLINE and Cochrane. Eligible articles were observational studies, clinical trials, systematic reviews, or meta-analyses that published within the last 5 years. All studies showed symptoms improvement with four studies using Pelvic Organ Prolapse Distress Inventory (POPDI) score and one study using International Consultation on Incontinence Questionnaire – Vaginal Symptoms (ICIQ-VS).


Introduction
Pelvic organ prolapse is an important and common medical condition. The International Continence Society (ICS) defines female pelvic organ prolapse as the descent of the anterior and or posterior vaginal wall or vagina apex (uterus or vaginal apex in women after a hysterectomy). 1 randomized, multicenter trial evaluated the 6-month success rate of sacral neuromodulation (SNM The prevalence of pelvic organ prolapse is uncertain due to the large number of women who do not seek medical care. 2 It is estimated that 50% of parous women lose pelvic floor support; as a result, develop prolapse but only 20-30% of these women are symptomatic. 3 Symptomatic prolapse has been shown to have a negative impact on woman's daily activities and her quality of life. 2 Currently, treatment modalities include pelvic floor muscle training, vaginal pessaries, and surgery. Surgical treatment features high recurrence rates and reoperation is required in 30-56% of cases in certain populations, making it a costly procedure. 4,5 In addition, surgery is also contraindicated for older women and those with comorbidities such as cardiac problems and uncontrolled high blood pressure. As an alternative, conservative treatment such as vaginal pessary is still commonly used and indicated for all pelvic prolapse stages. 6 there has been a renewed interest in pessaries as a conservative alternative to surgical repair for pelvic organ prolapse (POP The pessaries are intravaginal devices made of hypoallergenic plastic or silicone that is introduced into the vagina for the purpose of supporting the pelvic organs. 6 there has been a renewed interest in pessaries as a conservative alternative to surgical repair for pelvic organ prolapse (POP Several studies reported significant improvements in vaginal, urinary, bowel, and sexual symptoms. [7][8][9] health-related quality of life in women with pelvic organ prolapse. After a Medline search using the Mesh term 'pessary' and critical appraisal, 41 articles were selected and used in this review. Pessaries are widely used to treat pelvic organ prolapse. It is minimally invasive and appears to be safe. Although there is evidence that the use of pessaries in the treatment of pelvic organ prolapse is effective in alleviating symptoms and that patient satisfaction is high, the follow-up in many published papers is short, and the use of validated urogynaecological questionnaires is limited. Comparison with surgical treatment of pelvic organ prolapse is rare and not assessed in a randomised controlled trial.","author":[{"dropping-particle":The objective of the study was to compare pelvic floor symptom changes in patients who continue vs discontinue pessary use, and determine whether changes predict pessary continuation. Study Design: Women fitted with pessaries completed the Pelvic Floor Distress Inventory-20 (PFDI-20 However, there is still a lack of comparing trial in the setting of vaginal pessary as an intervention. Despite its limited evidence, the pessary is still commonly used in the treatment of genital prolapse and considered as the first line treatment by the American Urogynecologic Society (AUGS). 6,10 there has been a renewed interest in pessaries as a conservative alternative to surgical repair for pelvic organ prolapse (POP The aim of this evidencebased case report (EBCR) is to critically analyzed using newer studies whether the use of pessary improves the symptoms of pelvic organ prolapse compared to not using one.

Case Illustration
A 62-year old woman came to the gynecologic clinic with complaint of feeling a bulge in her vagina. It has happened in the last 6 months and sometimes she could saw something coming out from her vagina, especially when she was coughing. She was a housewife with 6 children with no cesarean history. No history of contraception and she had her menopause around 7 years before. The patient was diagnosed with uterine prolapse stage II and had pelvic exercise as the therapy from her doctor. As she felt very uncomfortable with the bulging sensation, the doctor also suggested the additional use of vaginal pessary.
As the doctor explaining how the pessary worked, she was afraid of the thought of inserting a foreign object into her body. She was wondering how effective it was compared to not using one as she already thought that maybe diet and exercise would be sufficient enough for herself. In woman who newly diagnosed uterine prolapse, does the pessary intervention improve the symptoms?

Formulation of Research
How is the effectiveness of pessary for improving the symptoms of pelvic organ prolapse?

Evidence Research Strategy
A search of literature was performed on May, 2019 in two databases namely MEDLINE and Cochrane. The keywords were "pessary", "pelvic organ prolapse", and "uterine prolapse" with their synonyms and related terms (Table 1). Eligible articles were observational studies, clinical trials, systematic reviews, or meta-analyses that published within the last 5 years. The search strategy, results, and the inclusion-exclusion criteria are shown in Figure 1. After literature selection, critical appraisal was done by consensus of all authors using several aspects based on Center of Evidence-Based Medicine, University of Oxford for therapy study.

Results
Following the search strategy, five original articles were eligible for this EBCR. 11,12 The design and summary of result is available on Table 2. The critical appraisal is shown on Table 3. Two articles were randomized controlled trial with level of evidence 1c and three observational cohort studies with level of evidence 2b.  Only 42% continued the treatment until the endpoint. The overall POPDI score was reduced to 45% of the baseline score. The overall POPIQ score was reduced to 44% of the baseline score. Two clinical trial studies had similar validity. 11,12 The groups were randomized and similar. Owing to the nature of the intervention, it was not possible to blind patients in these studies. Hence, only the investigators that were unaware of the treatment allocation (i.e. single-blinded). All studies had more than 20% number of loss to follow-up and/or dropout, based on initial randomization. Cheung et al 11 had equal treatment as all of its patients had pelvic exercises with no additional treatment except for the pessary in the intervention group. Both studies were using intention-to-treat analysis. Three observational studies were prospective cohort with no comparison or control group. [13][14][15] Thus, no validity criteria could be fulfilled.
From the aspect of importance, all studies showed symptoms improvement with four studies using pelvic organ prolapse distress inventory (POPDI) score and one study using International Consultation on Incontinence Questionnaire -Vaginal Symptoms (ICIQ-VS). Study from Cheung et al 11 and Panman et al 12 had better symptoms score in the pessary group compared to the control. The cohort studies also gave similar score but only Equal treatment + -n/a n/a n/a Intention-to-treat analysis Mean score pessary vs control data presented as median, higher score indicates more distress c data presented as mean, higher score indicates more distress d 95% CI could not be calculated e data presented as mean, higher score indicates more distress able to compare before and after the use of pessary. Confidence interval (CI) was used to assess the clinical significance of the results with Coelho et al 13 and Mao et al 14 showing good 95% CI. Cheung et al 11 provided us with the data of mean difference but not enough data for calculating the 95% CI, while Shayo et al 15 presented the data as median with no possibility to calculate the CI manually.

Discussions
All studies reported a tendency of symptoms improvement with the use of pessary. POPDI score was used as a validated score to assess the symptoms related to the pelvic organ prolapse. The score consisted of 16 questions for the long version or 6 questions for the short versions, both with similar reliability and overall responsiveness. 16,17 The questionnaire is widely referred to in the literature. 9,18,19 Another validated score, ICIQ-VS, was also used for the assessment of pelvic symptoms related to pelvic organ dysfunction. 20 Based on the validity components, the use of pessary as the intervention made it not possible to create a double-blind trial. Therefore, the risk of response bias could not be omitted from the results.
No study had small number of loss to follow-up and/ or drop-out. This was due to quite a large number of unsuccessful pessary fitting and failure of pessary continuation for the given time. There are many shapes and sizes of pessaries available to suit the needs of patients, with ring and gellhorn pessaries as the most widely used in the selected studies. Three studies from Coelho et al, 13 Mao et al 14 11 For the application in our case, the study from Cheung et al, 11 Panman et al 12 and Maoet al, 14 had the better similarity compared with the other two based on the mean patients' age. The mean age was too old in Coelho et al 13 and too young in Shayo et al. 15 All of the studies used the ring and gellhorn pessaries. Both pessaries are also widely available for our patient situation.
Pessary can be divided as support type and space-occupying type. 6 Several studies have evaluated the success of pessary fitting, with success rates ranging from 41% to 74%. 9,21,22 The definition of successful fitting is also varied considerably with variable lengths of follow-up, from a week to 36 months. Most protocols for pessary fitting were similar, with initial fitting using a ring pessary and transition to a space-occupying type if the ring failed. On average, 2 to 3 fittings were required until the appropriate pessary was found. 9,23,24 In addition, a lot of factors associated with unsuccessful fitting such as short vagina, wide introitus, young age, sexual activity, and symptom of incontinence. 6,21,23 This situation leads to a difficult standardized model of pessary.
Despite its internal use, it does not present serious adverse effect, proving to be safe. 6,7,11 However, high rate of discontinuation for lengthy usage still become the major challenge for applying pessary as the preferable treatment of pelvic organ prolapse. Common side effects include vaginal discharge and odor. Serious complications like fistula and erosion have all been reported but rare. 6 These limitations have made it difficult to run a high-quality clinical trial with small number of dropout. There is also still lack of studies comparing the effectiveness of pessary with other conservative treatment whose main outcomes would be the symptoms improvement, quality of life, and the satisfaction with the device usage.

Conclusions
Pessarium is one of the tool that can be used for conservative treatment for pelvic organ prolapse. Based on the several studies, the goal of pessarium use were to reduce symptoms that can be caused from pelvic organ prolapse. From these studies, pessarium was an effective and efficient way for pelvic organ prolapse. In one study, it was reported that over 90% patients were comfortable with the treatment and continued treatment until 6-12 months. After 24 months treatment, it was also stated that the use of pessarium correlates with the improvement of the symptoms in pelvic organ prolapse. The most common complaints from the therapy was vaginal discomfort, pain, and bleeding. To answer our patient, we should explain that there is a tendency that pessary usage improves the symptoms of uterine prolapse compared to not using it based on the research publications.