Cost-effectiveness of pessary therapy versus surgery for symptomatic pelvic organ prolapse: an economic evaluation alongside a randomised non-inferiority controlled trial.

OBJECTIVE: To evaluate the cost-effectiveness of pessary therapy as an initial treatment option compared with surgery for moderate to severe pelvic organ prolapse (POP) symptoms in secondary care from a healthcare and a societal perspective. DESIGN: Economic evaluation alongside a multicentre randomised controlled non-inferiority trial with a 24-month follow-up. SETTING: 21 hospitals in the Netherlands, recruitment conducted between 2015 and 2022. PARTICIPANTS: 1605 women referred to secondary care with symptomatic prolapse stage ≥2 were requested to participate. Of them, 440 women gave informed consent and were randomised to pessary therapy (n=218) or to surgery (n=222) in a 1:1 ratio stratified by hospital. INTERVENTIONS: Pessary therapy and surgery. PRIMARY AND SECONDARY OUTCOME MEASURES: The Patient Global Impression of Improvement (PGI-I), a 7-point scale dichotomised into successful versus unsuccessful, with a non-inferiority margin of -10%; quality-adjusted life-years (QALYs) measured by the EQ-5D-3L; healthcare and societal costs were based on medical records and the institute for Medical Technology Assessment questionnaires. RESULTS: For the PGI-I, the mean difference between pessary therapy and surgery was -0.05 (95% CI -0.14; 0.03) and -0.03 (95% CI -0.07; 0.002) for QALYs. In total, 54.1% women randomised to pessary therapy crossed over to surgery, and 3.6% underwent recurrent surgery. Healthcare and societal costs were significantly lower in the pessary therapy (mean difference=-€1807, 95% CI -€2172; -€1446 and mean difference=-€1850, 95% CI -€2349; -€1341, respectively). The probability that pessary therapy is cost-effective compared with surgery was 1 at willingness-to-pay thresholds between €0 and €20 000/QALY gained from both perspectives. CONCLUSIONS: Non-inferiority of pessary therapy regarding the PGI-I could not be shown and no statistically significant differences in QALYs between interventions were found. Due to significantly lower costs, pessary therapy is likely to be cost-effective compared with surgery as an initial treatment option for women with symptomatic POP treated in secondary care. TRIAL REGISTRATION NUMBER: NTR4883.

Pelvic organ prolapse: self-management of pessaries can be a good option.

The studyHagen S, Kearney R, Goodman K, et al. Clinical effectiveness of vaginal pessary self-management vs clinic-based care for pelvic organ prolapse (TOPSY): a randomised controlled superiority trial. eClinicalMedicine 2023;66:102326.To read the full NIHR Alert, go to: https://evidence.nihr.ac.uk/alert/pelvic-organ-prolapse-self-management-of-pessaries-can-be-a-good-option/.

Quality of Life after Treatment for Pelvic Organ Prolapse in Real-World Study: Recommendations, Vaginal Pessary, and Surgery.

Background and Objectives: Pelvic organ prolapse (POP) is a common condition in women, with its prevalence increasing with age, and can significantly impact the quality of life (QOL) of many individuals. The objective of this study was to assess the overall improvement, quality of life, and continuation of primary treatment for POP over a 24-month period in a real-world setting. Materials and Methods: This is a prospective, observational, follow-up study of women with symptomatic POP who, as a primary treatment, opted for recommendations (lifestyle changes and pelvic floor muscle training), pessary therapy, or surgery. The primary outcome measure was a subjective improvement at the 24-month follow-up, measured with the Patient Global Impression of Improvement (PGI-I) scale. Secondary outcome measures were the continuation rate of the primary treatment method, reason for discontinuation, and the quality of life evaluated with the P-QoL questionnaire. Results: We included 137 women, with 45 women (32.8%) in the recommendations group, 39 (28.5%) in the pessary group, and 53 women (38.7%) in the surgery group. After 24 months, surgery, in comparison with pessary treatment and recommendations, resulted in significantly more women reporting a subjective improvement: 89.6%, 66.7%, and 22.9% (p < 0.001), respectively. Overall, 52% of women from the recommendations group and 36.4% from the pessary group switched to another treatment or discontinued the primary treatment within 24 months. However, women who continued the primary treatment, pessary use, and surgery showed similar subjective improvements (90.5% and 89.6%, respectively) and quality-of-life improvement. Conclusions: The chance of significant improvement was higher following surgery. However, after 24 months, both vaginal pessaries and surgery showed an important quality-of life improvement and can be proposed as primary treatment methods for pelvic organ prolapse.

Vaginal pessary: a culprit for intraperitoneal bladder perforation.

Vaginal pessaries are widely considered to be a safe and effective non-surgical management option for women with pelvic organ prolapse. Complications may occur, and are more frequent with improper care and certain device designs and materials. It is imperative to provide information to patients about potential complications. We present the case of a woman in her 70s who presented to the Emergency Department with increasing groin and abdominal pain following a vaginal pessary insertion 2 days prior for grade 3 vaginal vault prolapse. On presentation, her abdomen was markedly distended with guarding. Laboratory investigations showed a significant acute kidney injury with a metabolic acidosis. An initial non-contrast CT showed fluid and inflammatory changes surrounding the bladder, and bladder perforation was suspected. A subsequent CT cystogram showed extravasation of contrast from the bladder into the peritoneal cavity, in keeping with an intraperitoneal bladder rupture. The patient underwent an emergency bladder repair in theatre.

A randomized clinical trial comparing internal and external pessaries in the treatment of pelvic organ prolapse in postmenopausal women: A pilot study.

INTRODUCTION AND HYPOTHESIS: Internal vaginal pessary is among the leading treatments for pelvic organ prolapse (POP); however, it has a high adverse event rate. An external pessary was recently developed as an alternative. The study's objective was to compare the efficacy of external and internal pessaries in treating POP in postmenopausal women. METHODS: This parallel randomized (1:1 ratio) open-blind study included 40 symptomatic women with stage 2 or 3 POP. They were randomized into two groups: group 1 (internal pessary) and group 2 (external pessary) (n = 20 in each); and evaluated at the start of and 3 months after the treatment. Statistical analysis was performed to compare the results within and between the groups before and after the 3-month treatment. RESULTS: The groups were homogeneous, except for the variables previous pregnancies (p = 0.030) and POP-Q score of apical prolapse (p = 0.023) whose values were higher in group 2. A significant improvement in quality of life was observed in both groups after 3 months of follow-up; however, internal pessaries were found to be more effective (p < 0.001). In group 1 there were differences between the initial and final POP-Q scores of anterior (0.004) and apical prolapse (p = 0.005). The complication rate associated with internal pessary use was high (p = 0.044). CONCLUSIONS: The present data suggested that external pessaries have a similar effect to internal ones for the treatment of POP and improvement of the quality of life of postmenopausal women.

The effect of the COVID-19 lockdown on women presenting with pelvic organ prolapse.

PURPOSE: To determine whether there is a difference in pelvic organ prolapse (POP) stage at time of presentation after lifting coronavirus disease (COVID-19) lockdown restrictions, as compared to before the lockdown. Enhancing our understanding of how healthcare utilization for pelvic floor disorders may be affected by limited accessibility, such as the COVID-19 pandemic, could prove invaluable for similar future circumstances. METHODS: This is a retrospective study of women with POP at their initial visit. Patients were grouped into two cohorts based on their initial presentation time: pre-COVID-19 lockdown (before March 2020) and post-COVID-19 lockdown (after December 2020). The cohorts were compared using demographic, clinical, and surgical variables. A logistic regression controlling for confounders was used to evaluate the influence of the COVID-19 lockdown on prolapse stage. RESULTS: There were 656 (50.3%) patients in the pre-COVID-19 lockdown cohort and 648 (49.7%) in the post-COVID-19 lockdown cohort. All baseline characteristics were similar between both cohorts except for race (p = 0.015). Treatment choices differed with the post-COVID-19 lockdown cohort having a lower proportion (26.5%) opting for surgery and a higher proportion (50.5%) of patients opting for nonsurgical interventions compared to the pre-COVID-19 lockdown cohort (p = 0.0005). A higher proportion of women presented with stages I and II prolapse in the post-COVID-19 lockdown (70.4%) cohort as compared to the pre-COVID-19 lockdown (62.5%) cohort (p = 0.002). CONCLUSIONS: Women in the post-COVID-19 lockdown cohort presented with early stage prolapse with preference for more conservative treatment options.

Long-term continuations rate of ring pessary use for symptomatic pelvic organ prolapse.

PURPOSE: To evaluate long-term continuation rates, adverse events of ring pessary use at a minimum of 5 years follow-up, and factors associated with discontinuation in symptomatic pelvic organ prolapse (POP). METHODS: Women with symptomatic POP who were treated with vaginal ring pessary and had successful fittings were included. Adverse events and reasons for discontinuation of pessary use were recorded. Patients who were lost to follow-up were defined as discontinuation. RESULTS: During 12 year-period, 239 of 329 POP patients (72.6%) had successful fittings with ring pessary. The mean age was 67.8 ± 8.9 years (range 27-86) and 70% of patients had advanced stage. The cumulative probability of continued ring pessary use was 84.1%, 64.4%, 49.3%, and 33.5%, at 1, 3, 5, and 10 years, respectively. Most common reason for discontinuation was frequent expulsion (21.6%), followed by vaginal erosion (16.5%), no prolapse improvement (12.4%), and inability or inconvenience to do self-care (9.3%). However, 9 patients (9.3%) had improvement of prolapse and were able to discontinue pessary insertion. Age above 70 years, wide introitus, and incapability of self-care are independent factors associated with long-term discontinuation. Adverse events occurred in 23.4% of patients, 18.8% of them had vaginal erosion, 11.7% vaginal discharge/infection, and 18.4% de novo SUI. However, no statistical significance existed between those who continued and discontinued pessary use due to these adverse events. CONCLUSION: Ring pessary is an effective treatment in symptomatic POP, with acceptable long-term continuation rates and minor adverse events. Self-care of pessary is very important aiming to minimize adverse events. Advanced age, wide introitus and incapability of self-care were associated factors for long-term discontinuation.

Enhancement of Levator Ani Muscle Strength in Postpartum Women: The Impact of Pelvic Floor Muscle Training.

BACKGROUND Levator ani muscle injuries during vaginal childbirth can lead to pelvic organ prolapse (POP). Pelvic floor muscle training (PFMT) is an effective conservative approach to alleviate these symptoms. This study aimed to compare outcomes with and without 3 months of PFMT in 34 women with levator ani muscle injury following vaginal delivery. MATERIAL AND METHODS In a quasi-experimental study, 34 postpartum women were divided into 2 groups: one received PFMT along with home-based materials and regular follow-ups, while the other served as the control. We measured basal tone and maximal levator ani muscle contraction using the Peritron perineometer and assessed changes after 3 months. RESULTS The basal tone and maximal contraction of the levator ani muscle significantly increased following a 3-month intervention period both in PFMT and control group (P=0.0001). The maximal contraction of the levator ani muscle after a 3-month intervention period was significantly higher in PFMT group compared with control group (36.59±1.45 vs 27.76±13.35, P=0.0001), respectively. A significant positive correlation was found between basal tone and maximal contraction (r=0.806, P=0.0001). CONCLUSIONS A 3-month PFMT program effectively increased levator ani muscle strength in postpartum women compared to those who did not undergo PFMT.

Effect of structured pelvic floor muscle training on pelvic floor muscle contraction and treatment of pelvic organ prolapse in postpartum women: ultrasound and clinical evaluations.

OBJECTIVES: The purpose of this study is to examine the impact of structured pelvic floor muscle training (PFMT) on pelvic floor muscle (PFM) contraction and the treatment of pelvic organ prolapse (POP) in postpartum women. METHODS: Sixty patients who volunteered for a PFMT assessment at 6-8 weeks after delivery were included in this retrospective analysis. For 5 weeks, all patients had structured PFMT, which included supervised daily pelvic muscle contractions, biofeedback therapy, and electrical stimulation. The main outcomes were POP stage assessed by POP quantification (POP-Q), pelvic organ position and hiatus area (HA) assessed by transperineal ultrasound, PFM contraction assessed by Modified Oxford scale (MOS), surface electromyography (EMG), and sensation of PFM graded using visual analog scale (VAS). RESULTS: Structured PFMT was associated with better POP-Q scores in Aa, Ba, C, and D (p values were 0.01, 0.001, 0.017, and 0.001 separately). The bladder neck at rest and maximum Valsalva, the cervix position and HA at maximum Valsalva in transperineal ultrasound were significantly better than before (p values were 0.031, < 0.001, 0.043, and < 0.001 separately). PFM contraction assessed by MOS, EMG, and PFM VAS score were significantly improved (all p values were < 0.001). However, no significant improvement was observed in POP-Q stage. CONCLUSIONS: Structured PFMT can increase PFM function in postpartum women but cannot modify the POP-Q stage. Transperineal ultrasonography is a useful method for evaluating therapy efficacy objectively. More randomized controlled trials are needed before definitive conclusions can be drawn about the effect of structured PFMT on POP in postpartum women.

Outcomes of pessary fitting trials for patients with stage IV pelvic organ prolapse: a prospective study.

INTRODUCTION AND HYPOTHESIS: The objective was to evaluate the efficacy of pessaries in the treatment of stage IV pelvic organ prolapse (POP) and identify the influencing factors. METHODS: One hundred and fifty-seven patients with stage IV symptomatic POP were admitted to the hospital for pessary fitting. A successful pessary fitting was defined as a patient fitted with a pessary at the initial fitting in whom use continued 2 weeks later. The rates of successful pessary fitting, patient satisfaction, remission of prolapse and urinary symptoms, and the occurrence of factors associated with successful pessary fitting were calculated and predictors of appropriate pessary type selection were analyzed. RESULTS: A total of 130 patients with stage IV POP had a successful pessary fitting (82.8%). The satisfaction rate associated with the two types of pessaries was more than 90%. The success rate among patients undergoing a ring pessary fitting trial was 44.6%, and 84.3% of the patients were self-managed. Prolapse symptoms significantly improved in 90% of cases, and urinary symptoms improved in 58-93% of cases from baseline. The number of vaginal deliveries, history of hysterectomy and vaginal introitus/total vaginal length (TVL) ratio were independent risk factors associated with unsuccessful pessary fitting. CONCLUSION: For patients with stage IV POP, the successful fitting rate is as high as 80% or more. More vaginal deliveries, a history of hysterectomy, and a larger vaginal introitus/TVL ratio (ratio >0.6) were predictors of unsuccessful pessary fitting.

Analysis of questions by patients with pelvic organ prolapse about vaginal pessaries resulting in a checklist for their physicians.

OBJECTIVE: International guidelines recommend vaginal pessaries as a first-choice treatment of symptomatic pelvic organ prolapse (POP). Gynecologists rarely receive systematic training or just do not take the time to communicate with their patients. We hypothesized that we could identify key deficits and limitations of counseling before or during pessary therapy from questions directed to manufacturers with the aim to improve and promote health literacy of women with POP. METHODS: We approached five manufacturers to provide anonymized inquiries related to pessary use. After exclusion of duplicates and questions about obstetric pessaries, 174 data sets from 145 patients remained. RESULTS: In 19/145 patients (13.1%), a 2nd degree, and in 94/145 (64.8%), a 3rd-4th degree of POP was identified. Four patients had additional urinary incontinence. In 32/145 (22.1%), the severity of POP could not be identified. The age of patients ranged from 27 to 98 (mean = 63.7) years. Most inquiries were related to the selected pessary models or sizes (40/174; 22.9%), self-management (20/174; 11.5%), and technical aspects such as shelf life or appropriate cleaning (26/174; 14.9%). Pain or voiding dysfunction was present in 17/174 remarks (9.7%). Lifestyle questions related to the use of pessaries during sport, menstruation, or mechanical anticonception. The cube pessary was in the focus of interest followed by the sieve bowl, urethra, ring, and Gellhorn device. The list of questions was summarized as a checklist stratified according to priorities. CONCLUSION: The checklist should help improve counseling and self-management of patients to optimize the benefit/risk ratio of conservative treatment of pelvic floor diseases.

Adherence to support pessary in the treatment of pelvic organ prolapse: a retrospective study conducted among 1,371 women.

INTRODUCTION AND HYPOTHESIS: The objective was to investigate the adherence to pessary treatment in women with pelvic organ prolapse (POP) who were found eligible for this treatment by the urogynecologist, at the first visit at the Department of Gynecology and Obstetrics, Odense University Hospital. METHODS: Data were extracted from the women's medical records. Frequency tabulations were performed to describe the women's reasons for pessary discontinuation by age group. Binominal logistic regression analysis was conducted to investigate how women's age, POP characteristics, urogynecological history, and their pessary experience and management were associated with continued pessary use. RESULTS: This study included 1,371 women treated with support pessary. Of these, 850 women continued pessary treatment and 521 women underwent surgical treatment. A history of hysterectomy (OR: 0.68, 95% CI: 0.51-0.90, p = 0.008), urinary incontinence (OR: 0.71, 95% CI: 0.56-0.89, p = 0.003), and previous pessary use (OR: 0.75, 95% CI: 0.56-0.99, p = 0.047) were significant factors associated with discontinuation. Further, women aged 81-99 years were significantly more likely to continue pessary treatment (OR: 1.77, 95% CI: 1.15-2.74, p = 0.009). "POP surgery," "prolapse stage," and "prolapse predominant compartment" were not associated with discontinuation. Approximately 38% of women aged 26-54 years discontinued owing to personal preference. CONCLUSIONS: Hysterectomy, incontinence, and previous pessary use are significant predictors of pessary discontinuation. Increasing age is significantly associated with pessary continuation.

Vaginal microflora following the use of a disposable home-use vaginal device and a commercially available ring pessary for pelvic organ prolapse management: a randomized controlled trial.

PURPOSE: To investigate whether ProVate, a novel, disposable, self-inserted vaginal device for pelvic organ prolapse management, clinically affects the vaginal microflora, as compared with a commercially available ring pessary, to assess its microbiological safety. METHODS: This interventional, prospective, multi-center, open-label, randomized, controlled, statistically powered (noninferiority), home-use, crossover study was conducted at seven sites. Participants were randomized into either group A (using ProVate and then a new reusable commercially available ring pessary [control]) or B (using control device and then ProVate) with a 1:1 ratio. Noninferiority of ProVate over the control was evaluated for the primary endpoint, which was based on meeting one of the failure criteria: significant change in Lactobacillus spp., Gardnerella vaginalis, Candida morphotypes, or Staphylococcus aureus levels compared to the baseline (significant change: Nugent score ≥ 7 or > 1 scale unit increase in S. aureus or Candida morphotype), bothersome vaginal infection symptoms, or symptoms requiring treatment for infection. RESULTS: The study included 58 participants (mean age: 64.5 years, 91.4% postmenopausal). There were no significant microfloral changes in terms of the four microorganisms mentioned above, the rate of Nugent score ≥ 7 after use was low and comparable between the two devices, and the rate of patients with a > 1 unit-scale change (increase or decrease) from the baseline to the end-of-use phase in any studied microorganism was comparable between the devices. The failure rate was 15.5% for ProVate and 15.5% for control while using 383 ProVate devices over 1647 days or one control device throughout the study. Two patients had bothersome vaginal complaints and one had overt vaginal infection in the control group, but no such cases were observed in the ProVate group. CONCLUSION: The primary endpoint of possible vaginal microbial changes, bothersome vaginal symptoms, or treatment-requiring vaginal complaints while using ProVate was successfully met. Our findings show that the vaginal microflora is comparable when using either ProVate or commercially available ring pessary (control) with a relatively low rate of vaginal infections. Trial registration details: ClinicalTrials.gov; URL: https://www. CLINICALTRIALS: gov/ct2/show/NCT03345121?term=NCT03345121&draw=2&rank=1 ; No. NCT03345121; Registration date, November 17, 2017; initial enrollment started on August 20, 2017.

Pessaries for pelvic organ prolapse: evaluation of vaginal discharge and pain during pessary cleaning in an outpatient setting.

INTRODUCTION AND HYPOTHESIS: Pessary treatment for pelvic organ prolapse (POP) is effective and safe, but long-term continuation is low. Pain and vaginal discharge may play a role. This study was aimed at evaluating vaginal discharge and pain during pessary cleaning in an outpatient setting and in continuous pessary use. METHODS: Women with POP who attended the outpatient clinic for pessary cleaning between January and October 2021 were included. Primary outcome was pain during removal and reinsertion of the pessary, measured by an 11-point numeric rating scale (NRS). Secondary outcome was vaginal discharge, measured by the NRS and Patient Global Impression of Change scale (PGI-C). Multiple linear regression analysis was used to identify associated variables for pain and discharge. RESULTS: A total of 150 women were included. Mean NRS during pessary removal was 4.3 (± 2.7), with 25% of women scoring a 7 or higher. Mean NRS during reinsertion was 1.8 (± 2.0). A smaller genital hiatus and presence of vaginal atrophy or vulvar skin disease were associated with pain during pessary removal. Mean NRS for vaginal discharge was 2.5 (± 2.3). Twenty-five percent of women reported that their vaginal discharge was "(very) much worse" than before they used a pessary. Presence of vaginal erosions was associated with vaginal discharge in this study population. CONCLUSIONS: Removing a pessary in an outpatient setting is a painful procedure for many women who use a pessary continuously. Moreover, 25% of these women experience an increase in vaginal discharge while using a pessary. Future research should focus on reducing these disadvantages.

Pelvic organ prolapse: Women's experiences of Accessing Care & Recommendations for improvement.

Up to 50% of women will develop pelvic organ prolapse (POP) over their lifetime. Symptoms include pain, bulge, urinary, bowel and sexual symptoms affecting all aspects of a woman's life.Many women with POP symptoms present initially to primary care settings. Research has shown these interactions are often unsatisfactory, with women reporting their health care professional (HCP) trivialized their symptoms or appeared to have poor knowledge about pelvic floor dysfunction (PFD).Aim The aim of this qualitative study was to explore experiences of younger women seeking treatment for POP and their recommendations for improvements.Methods Ethics approval was obtained (LS-21-01-Carroll-Ful). Women with POP were recruited from an online support group (n = 930 members). Inclusion criteria: adult women, diagnosed with POP and aware of their POP stage. Following informed consent, a demographic questionnaire, interview questions and the Central Sensitization Inventory (CSI) were forwarded. Semi-structured zoom audio-recorded interviews were conducted. Thematic analysis was undertaken; transcripts coded, and themes identified.Results Fourteen women aged 32-41, parity 1-3, with POP Grade 1-3 participated. Many women reported HCPs as dismissive or not appreciative of the impact of their condition. Others described interactions with HCPs who they felt listened, understood the impact of their POP, gave simple explanations, a positive prognosis and outlined a realistic treatment plan.Current antenatal education, post-partum care and primary HCP screening for PFD were identified by women as deficient. Many highlighted delays in accessing specialist care for POP. Women made several recommendations for improvements to the current model of care.Conclusions Increased focus on person-centred care, particularly emotional support, information and education may improve younger women's experiences when seeking care for POP.

The usage of Gellhorn pessary in pelvic organ prolapse and in regards to success, continuity of use and effect on symptoms: a retrospective study of 2 years.

INTRODUCTION: Pelvic organ prolapse (POP) is a condition involving weakened pelvic floor muscles causing organs to protrude. Conservative POP treatment comprises pelvic floor exercises and vaginal pessaries. Besides conservative care, surgery is offered. However, surgery is invasive, risky and unsuitable for those with serious medical conditions. This study aims to assess the acceptance, success and outcomes of the Gellhorn pessary for POP treatment, especially in advanced cases. MATERIALS AND METHODS: The present study is a retrospective cohort study using hospital medical records (patient files) from October 2019 to November 2021 (for 2 years). This study was performed in Malaysian women (n=53) suffering from advanced stages of POP, in which Gellhorn pessaries of diameter (44-76mm) were inserted by trained personnel. Pelvic Floor Distress Inventory-20 (PFDI-20) and Pelvic Floor Impact Questionnaire-7 (PFIQ-7) were used to measure patients' symptoms and quality of life before and after Gellhorn pessary fitting. Patients were reassessed every three months for two years and their satisfaction scores were recorded. RESULTS: We observed a significant difference in pre-test (pre-fitting) and post-test (three months post-fitting) scores on all three subscales and the PFIQ-7 total score. Twentyeight (52.83%) patients continued the use of Gellhorn pessary for at least 24 months, whereas 25 (47.20%) patients discontinued during this period. A retrospective analysis of the patients who discontinued Gellhorn pessary showed that 13 (24.52%) patients gave up the use of pessary for definitive surgery. It is noteworthy to mention here that only one out of the 13 patients who were awaiting surgery, chose surgery and the remaining 12 changed their mind after being fitted with the Gellhorn pessary. Seven (13.20%) patients declined reinsertion due to discomfort and voiding difficulties and refused further intervention, whereas three (5.66%) patients requested a ring pessary. Two (3.77%) patients, requested the removal of pessary due to vesicovaginal fistula and rectovaginal fistula (caused by an impacted pessary). The rate of continued use was 79.24% (42 patients) after 1st year and 52.83% (28 patients) at the end of two years. CONCLUSION: In the current study, the Gellhorn pessary was used to treat stage 3 and 4 POP with significant symptom reduction post-fitting. More than half of the patients continued to use the pessary after 24 months of fitting. Therefore, the Gellhorn pessary can be used as a treatment strategy for stage 3 and 4 POP with reasonable acceptance in the Malaysian population.

Awareness of pelvic organ prolapse and attitude towards its treatment among Malaysian women.

INTRODUCTION: The aim of this study is to determine the level of awareness of pelvic organ prolapse (POP) and factors that influence the attitude towards the treatment of POP among Malaysian women. MATERIALS AND METHODS: This was a cross-sectional study of 400 women from registered non-government organisations (NGOs) in Malaysia who voluntarily answered questionnaires distributed through Google form via emails. Data were analysed using descriptive statistics, independent t-test and one-way ANOVA test. RESULTS: Four hundred respondents participated in this study. The mean age was 40.42 years old (SD=12.566). The mean score for the studied population was 4.96 (SEM 0.124). Only 58 (14.5%) respondents obtained a score of eight or more, and 235 (58.8%) respondents scored between 4 and 7. The rest of 107 (26.7%) respondents scored 3 and less. There were statistically significant differences in the mean score for level of awareness between marital statuses, menopausal status, number of children and occupation. There were only 273 (68%) respondents who will seek treatment if they experience symptoms of POP. The most frequent reasons for not seeking treatment were unawareness of the availability of medical treatment for POP (69 %). CONCLUSION: Majority of the respondents have an inadequate level of awareness on POP. Although more than half of the respondents will seek treatment if they experience symptoms of POP, concerns raised by those who chose not to seek treatment should be addressed by a more effective public awareness programme. This includes the unawareness of the availability of medical treatment and the embarrassment to see medical practitioners.

Effectiveness of exercise interventions on urinary incontinence and pelvic organ prolapse in pregnant and postpartum women: umbrella review and clinical guideline development.

INTRODUCTION AND AIMS: Dysfunction related to pelvic floor muscles (PFM) is common among pregnant and postpartum women and can cause symptoms such as urinary incontinence or pelvic organ prolapse (POP). As part of developing a nationwide clinical practice guideline for nursing in Finland, the aim of this umbrella review is to summarize the existing evidence about the effectiveness of exercise interventions on urinary incontinence and POP in pregnant and postpartum women. To promote knowledge translation, recommendations for health care professionals are presented. METHODS: We conducted an umbrella review to summarize the existing evidence. The JBI methodology for umbrella reviews was used to guide the review. The level of evidence was evaluated using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach, and recommendations based on the evidence were formulated by a clinical guideline working group. RESULTS: Altogether, 9 systematic reviews, reporting findings from 89 original studies, were included. The methodological quality of the reviews was evaluated using JBI's checklist. The highest level of evidence was found for preventing the symptoms of postpartum urinary incontinence through exercise and pelvic floor muscle training (PFMT) during pregnancy. Moderate-level evidence showed that exercise and PFMT are likely to reduce the symptoms and severity of urinary incontinence, but the level of evidence was low on PFMT reducing the symptoms of POP. CONCLUSION: We recommend encouraging and guiding pregnant and postpartum women to exercise and train PFM. We also recommend identifying pregnant and postpartum women with symptoms of PFM dysfunction and directing them to a physiotherapist or other health care professional specializing in pelvic floor function.

Microbiome alterations in women with pelvic organ prolapse and after anatomical restorative interventions.

Pelvic organ prolapse (POP) is a benign gynecological disease in which the pelvic organ descends into the vagina and causes voiding, and defecatory dysfunction, mainly occurs in older women. This study aimed to investigate the vaginal microbiome of POP and associated changes after anatomical restorative pessary or reconstructive pelvic operation. We analyzed the vaginal microbiome using 16S ribosomal RNA gene sequencing and compared the results among patient groups with POP, pessary, and postoperation. We also measured 10 inflammation-related cytokines in vaginal swab samples using multiplex immunoassay. In pelvic organ prolapse, vaginal community status type IV was the most prevalent, which showed a low abundance of Lactobacillus with increased diversity and abundance of anaerobic species. The alpha diversity of species richness was highest in the POP group. The beta diversity distance differed significantly between the three groups (p = 0.001). While human intestinal taxa-associated bacteria were reduced after pessary or operation, vaginitis-associated bacterial composition was altered but vaginal microbiome homeostasis was not improved. IFN-γ, IL-10, IL-12p70, IL-1ß, IL-4 and TNF-α levels increased in the pessary group. Therefore, in addition to anatomical restorative treatment, supplementary treatment focusing on the recovery of the vaginal microbiome may be needed to maintain the health of gynecological organs in old age.

Long-term adherence to pessary use in women with pelvic organ prolapse: A retrospective cohort study.

PURPOSE OF THE RESEARCH: Vaginal pessary use is an established, non-surgical treatment option for pelvic organ prolapse. While satisfaction rates are initially high, they seem to decline over time. We aimed to determine the median duration of pessary use among our patients and to evaluate reasons for discontinuation. METHODS: All patients who were treated with a vaginal pessary for pelvic organ prolapse between 2007 and 2022 at our institution (a maximum observation period of 15 years) were included in this retrospective cohort study. Data were collected from the in-house electronic databases and the date of pelvic floor surgery was defined as the primary endpoint. In case of no documented surgery, the date of the last follow-up visit (for patients lost to follow-up or who discontinued pessary use without subsequent surgery) or the date of final data collection (for those with presumed continued pessary use) was used as the primary endpoint. Duration of pessary use is represented by Kaplan-Meier curves. Effects of possible confounders were investigated by Cox regression models. A Cox regression model was evaluated for patients with the three most common types of pessary: ring, cube and shell. A chi-square test was performed to compare therapy adherence according to pessary type. PRINCIPAL RESULTS: Data of 779 patients could be included in the statistical analysis. The estimated median duration of pessary use was 173 weeks (95 % CI 104-473) - approximately 3.3 years. Overall, 30 % of patients opted for surgical therapy and the majority of them did so within 4 months of initiation of pessary use (median time: 19 weeks, 95 % CI 16-26). In 5 % of cases a discontinuation of pessary use without subsequent surgery was documented and 18 % were lost to follow-up before a planned visit, thus leaving 47 % of our patients with presumed continued pessary use. Possible confounding factors for discontinuation of pessary use were tested but were found to be non-significant (body mass index, Pelvic Organ Prolapse - Quantification score, pelvic floor training, age, parity, menopausal status, nicotine consumption, incontinence or size of pessary). Reasons for discontinuation of pessary use were documented in 51 % of patients: unspecified patient wish (23 %), pessary use tiredness (10 %), general dissatisfaction with pessary therapy (7 %), unspecified reasons (5 %), pessary self-change not possible (1 %), erosion, bleeding, pain (2 %); none of the pessary types fitted (2 %). CONCLUSIONS: According to our data, almost half of our patients with pelvic organ prolapse and pessary therapy continued pessary use until a maximum follow-up time of 15 years, whereas about one-third of patients finally opted for surgical repair (a majority of these within 4 months after pessary therapy initiation). The remaining patients were either lost to follow-up or discontinued pessary use without subsequent surgery. The stated reasons for discontinuation of pessary use were mostly non-specific, but only 1 % reported that pessary self-change was not possible. Erosion bleeding or pain was documented in only 2 % of cases as reason for discontinuation. This information helps clinicians to inform their patients with pelvic organ prolapse about expected pessary therapy success and strengthens individual counselling. Furthermore, our data indicates vaginal pessary use for pelvic organ prolapse is feasible and safe for all women and that therapy adherence can extend beyond 5 years.