Cross sectional study on assessment of ring pessary cleaning and removal every six months: adverse events and complications.

INTRODUCTION AND HYPOTHESIS: Despite its frequent use, there is little evidence of adequate management of pessaries for treating pelvic organ prolapse (POP). Thus, the aims the study were to assess the rate of complications in women using ring-type pessaries with cleaning and monitoring every 6 months and to correlate the time of use of the pessary with possible complications. METHODS: This is a cross-sectional study including women diagnosed with stage 3 or 4 genital prolapse, who were already in outpatient follow-up and who used a ring pessary. We excluded patients using another type of pessary, with severe comorbidities and with POP-Q ≤ 2 staging. The chi-square test or Fisher exact test was applied for categorical variables, the t-test for continuous variables with normal distribution and Mann-Whitney test for non-parametric variables. RESULTS: A total of 83 women using a ring pessary were assessed. The mean in months of pessary use was 31.8 ± 14.9 months. Vaginal discharge was the most frequent complaint representing 26.5%, followed by foul smell in 13.3%. No significant correlation was found between length of pessary use and clinical variables. However, a significant correlation was found between immediate complications and the length of pessary use (21.3 ± 5.9 months; p < 0.0044). CONCLUSION: There was no increase in complication rate in the continuous use of a ring pessary with cleaning and monitoring every 6 months. Determining a follow-up time that reduces the risk of complications is necessary not only for the organization of the attendance services, allowing a greater number of monitored patients, but also for the access of patients who need regular monitoring.

ESTROgen use for complications in women treating pelvic organ prolapse with vaginal PESSaries (ESTRO-PESS)-a randomized clinical trial.

INTRODUCTION AND HYPOTHESIS: To evaluate the complications of new users' vaginal pessaries (VP), with and without the use of vaginal estrogen after a 6-month follow-up. METHODS: A parallel, single-blinded, randomized, controlled trial. Symptomatic postmenopausal women (n = 98) with pelvic organ prolapse (POP) (stage 3/4) were recruited from August 2018 to October 2019. Patients were randomized into the local estrogen group (promestriene 3 × for a week) and the control group (no estrogen). They were evaluated for their vaginal symptoms at the baseline, after 3 months, and after 6 months, and a physical examination and vaginal sampling for microbiological analysis were done. Data were analyzed according to an intention-to-treat analysis (ITT). A 5% significance level was established for statistical analysis. RESULTS: Twenty women discontinued treatment (20.4%), mainly due to pessary extrusion (n = 15) and 5 for other reasons (lost to follow-up, pain, and surgery). Baseline characteristics were not statistically different between the estrogen and control groups. Regarding the presence of complications, the presence of erosion was 10% in the control group, but there was no significant difference between the groups (p = 0.175) after 6 months. Bacterial vaginosis (BV) was more prevalent in the control group, according to the Nugent (p = 0.007) and Amsel (p = 0.014) criteria. Urinary urgency and increased urinary frequency were significantly improved in the estrogen group after 6 months. CONCLUSION: There was no evident benefit related to complications such as ulcerations, itching, and vaginal discharge/odor from the use of vaginal estrogen in POP women using pessaries.

Factors associated with unsuccessful pessary fitting in women with symptomatic pelvic organ prolapse: Systematic review and metanalysis.

AIMS: To identify the factors associated with unsuccessful pessary fitting and reasons for discontinuation for women with symptomatic pelvic organ prolapse (POP). METHODS: This systematic review is registered at the PROSPERO database. We have included all studies, regardless of the study design whose primary outcomes were factors associated with unsuccessful pessary fitting and discontinuation for symptomatic POP women. Exclusion criteria were case series, literature reviews, other forms of conservative treatment. Data selection/extraction was performed by two investigators. For pessary fitting, a meta-analysis was performed for at least two studies pooled in a forest plot. The risk of bias was classified by the ROBINS-I and ROB-2 classification. RESULTS: From 409 studies retrieved after data search, only twenty-one articles remained for final analysis (18 cohort studies, 1 cross-sectional study, and 2 RCTs). Meta-analysis was performed in nine studies for pessary fitting and the associated factors were: higher body mass index (BMI) (MD = 0.688 [0.233-1.143]; P = .03; i2 = 0%), previous reconstructive surgery (OR = 1.705 [1.016-2.860]; P = .043; i2 = 69%) and advanced POP (OR = 4.2 [2.9-6.1]; P < .05; i2 = 92%). Older age, larger total vaginal length (TVL), and genital hiatus and previous hysterectomy were not associated factors. Regarding discontinuation, thirteen reasons were quoted, and the most frequent were: the desire for surgical treatment (111/3.601), pessary extrusion (385/3.601), and pain/discomfort (163/3.601). CONCLUSION: Obese, previously reconstructive pelvic surgery, advanced prolapse are at risk for unsuccessful pessary fitting. Pain is the most quoted reason for discontinuation. These pooled data may help clinicians to identify patients that may not succeed in their attempt for pessary treatment.

Female pelvic organ prolapse using pessaries: systematic review.

INTRODUCTION AND HYPOTHESIS: The purpose of this systematic review is to assess the impact of pessary use on the quality of life of women with pelvic organ prolapse, and to determine the satisfaction rate and rationale for discontinuation. METHODS: This review is recorded in the PROSPERO database under number CRD42015023384. The criteria for inclusion were observational study; cross section; cohort study; randomized controlled trial; study published in English, Portuguese, and Spanish; and study whose participants are women with female pelvic organ prolapse treated using a pessary. We did not include limitations on the year of publication. The criteria for exclusion included studies that did not include the topic, bibliographic or systematic reviews and articles that did not use validated questionnaires. The MeSH terms were "Pelvic Organ Prolapse AND Pessaries AND Quality of Life" OR "Pessary AND Quality of Life" OR "Pessaries". RESULTS: We found 89 articles. After the final analyses, seven articles were included. All articles associated pessary use with improved quality of life, and all used only validated questionnaires. Over half of the women continued using the pessary during the follow-up with acceptable levels of satisfaction. The main rationales for discontinuation were discomfort, pain in the area, and expulsion of the device. CONCLUSION: This systematic review demonstrates that the pessary can produce a positive effect on women's quality of life and can significantly improve sexual function and body perception.