Management of short cervix in twin-to-twin transfusion syndrome: a role for pessary placement following fetoscopic laser surgery?

BACKGROUND: Preterm labor and delivery is a major concern for patients with twin-to-twin transfusion syndrome undergoing fetoscopic laser surgery. A preoperative short cervix is a risk factor for preterm labor. Pessary placement is a short-acting intervention that may be useful to reduce this adverse event. OBJECTIVE: This study aimed to investigate the relationship between pessary placement and preterm delivery in monochorionic twin pregnancies with twin-to-twin transfusion syndrome and a short cervix before fetoscopic laser surgery. STUDY DESIGN: This was a retrospective study in 2 centers, including all pregnancies affected by twin-to-twin transfusion syndrome that underwent fetoscopic laser surgery with the Solomon technique between 2013 and 2022 (center A) and 2014 and 2022 (center B) with a preoperative cervical length below 25 mm. This study explored the correlation between cervical length and fetoscopic laser surgery-to-delivery interval following active or expectant management and compared perinatal outcomes between patients managed expectantly and patients managed with pessary placement, using multivariate analysis to control for potential confounders. Patients with a cervical length below 5 mm were not included in the comparative analysis. RESULTS: Of 685 patients, 134 met the inclusion criteria. Moreover, 21 patients were treated with a cervical cerclage and excluded from the analysis, leaving 113 patients for the final analysis. There was a significant negative correlation between cervical length at fetoscopic laser surgery and the risk of early delivery (adjusted odds ratio, 0.66; 95% confidence interval, 0.49-0.81; P<.001). The use of a pessary correlated with fewer patients delivering before 28 weeks of gestation (adjusted odds ratio, 0.28; 95% confidence interval, 0.09-0.75), fewer double neonatal demise (adjusted odds ratio, 0.2; 95% confidence interval, 0.05-0.75). Posthoc subgroup analysis suggested that these improvements were essentially noticeable for cervical lengths between 5 and 18 mm, where pessary placement was associated with an increased fetoscopic laser surgery-to-delivery interval (+24 days; 95% confidence interval, 0.86-42; P=.042) and later gestational age at delivery (+3.3 weeks; 95% confidence interval, 0.86-42; P=.035). CONCLUSION: Patients with a moderately shortened cervix, between 5 and 18 mm, may benefit from pessary placement after fetoscopic surgery for twin-to-twin transfusion syndrome, resulting in a reduction of adverse neonatal outcomes, double neonatal demise, and severe preterm delivery.

Patient experience of pain during vaginal pessary removal and insertion: a service evaluation study.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse is a common problem affecting women, but there is currently a lack of research focusing on patient experience of pessary changes. This study was aimed at capturing the patient perspective of pessary changes and formally assessing pain during pessary removal and insertion. METHODS: A service evaluation request was granted by South Tees Hospitals NHS Trust. Patients undergoing pessary change (ring, shelf, or Gellhorn) in gynaecology outpatient clinics over a 6-month period were asked to rate their pain scores on a ten-point numerical pain-rating scale. Other associated data were collected. RESULTS: Out of 213 women, 58.2% reported that pessary removal was more painful than insertion, 30.5% reported equal pain, and 10.8% reported that insertion was more painful than removal. Pain scores were significantly higher for removal (mean 4.37, median 4, IQR 4-7) than for insertion (mean 2.66, median 2, IQR 2-4, p <0.001). Ring pessaries were significantly less painful to both remove and insert than shelf and Gellhorn pessaries. Smaller pessaries were more painful to both remove and insert. There was no significant difference in pain scores reported by those with or without diagnosed vulval conditions. CONCLUSIONS: Pessary removal causes most women moderate pain, which should be communicated to patients beforehand. Ring pessaries are significantly less painful to change than other pessary types. Clinicians should consider pain as a factor in their decision-making surrounding pessary choice and when counselling patients. Future research should focus on ways to reduce pain during pessary removal.

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.

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.

Transition to surgery after pessary among female Medicare beneficiaries with pelvic organ prolapse.

BACKGROUND: The American College of Obstetricians and Gynecologists recommends offering a vaginal pessary to women seeking treatment of pelvic organ prolapse. However, single-institution series have suggested that a sizable proportion of women fitted with a pessary will transition to surgery within the first year. OBJECTIVE: This study aimed to estimate the proportion of female US Medicare beneficiaries with pelvic organ prolapse who undergo surgery after pessary fitting, to describe the median time to surgery from pessary fitting, and to identify factors associated with the transition from pessary to surgery. STUDY DESIGN: The Medicare 5% Limited Data Set was queried from 2011 to 2016 for women aged ≥65 years with a diagnosis of prolapse who underwent pessary fitting. Cases with at least 3 years of follow-up in the Medicare Data Set were followed longitudinally for the primary outcome of surgery for prolapse. The cumulative incidence of prolapse surgery following index pessary fitting was calculated. Characteristics of women who underwent surgery and those who did not were compared using time-varying Cox regression analysis. RESULTS: Among 2032 women fitted with a pessary, 608 underwent surgery within 7 years. The median time to surgery was 496 days (interquartile range, 187-1089 days). The cumulative incidence of prolapse surgery was 12.2% at 1 year and 30.9% at 7 years. After adjusting for covariates, factors significantly associated with the transition to surgery included previous prolapse surgery (adjusted hazard ratio, 1.50; 1.09-2.07) and a diagnosis of urinary incontinence at the time of pessary fitting (adjusted hazard ratio, 1.20; 0.62-0.99). Factors associated with a lower hazard of surgery included age (adjusted hazard ratio, 0.96 per year; 95% confidence interval, 0.95-0.97), dual Medicare/Medicaid eligibility (adjusted hazard ratio, 0.75; 95% confidence interval, 0.56-1.00), and pessary fitting by a nongynecologist (adjusted hazard ratio, 0.78; 95% confidence interval, 0.62-0.99). CONCLUSION: In this population of Medicare beneficiaries, within 7 years of pessary fitting, almost one-third of women aged >65 years underwent surgery for prolapse. These results add to our current understanding of the demographics of pessary use in an older population and may aid in counseling older patients presenting for treatment of symptomatic pelvic organ prolapse.

Self-management of vaginal cube pessaries may be a game changer for pelvic organ prolapse treatment: a long-term follow-up study.

INTRODUCTION AND HYPOTHESIS: Loss of anatomical support for the pelvic organs results in pelvic organ prolapse (POP). We hypothesized that daily self-management of a cube pessary might be a safe, feasible long-term treatment in women with symptomatic POP. METHODS: A cohort of 214 symptomatic POP patients (stage 2+) were enrolled prospectively (January to December 2015). Each patient was size-fitted with a space-filling cube pessary and completed a questionnaire online or by phone ≥5 years after her initial fitting. Change in quality of life (QoL) was measured with the Patient Global Impression of Improvement (PGI-I). RESULTS: Of 185 women included in our analyses, 174 (94%) were continuing to use their pessary 4 weeks post-insertion. Among those, 143 (82.2%) used the pessary successfully for ≥5 years. A large majority of these patients (88.8% [127 out of 143]) described their condition as much or very much improved compared with their pretreatment status (PGI-I). Adverse secondary effects (ASEs) were infrequent [15.4% (22 out of 143)]; when they did occur, they were mild, including smelly vaginal discharge (15 out of 22) and slight vaginal bleeding caused by the fitting procedure (6 out of 22). CONCLUSIONS: Daily self-management of cube pessaries was found to be a safe and effective treatment for improving POP-related symptoms and QoL in the long term.

Are older patients with prolapse likely to continue pessary use? A retrospective observational study.

INTRODUCTION AND HYPOTHESIS: To review the outcomes and complications of vaginal prolapse management with pessaries in women aged 75 years or older, to ascertain whether pessaries are providing satisfactory long-term outcomes for older women. METHODS: A retrospective observational study was performed on women aged 75 years or older presenting to a tertiary Urogynaecology service with vaginal prolapse who opted for management with a vaginal pessary. Demographic and clinical data were collected by reviewing clinical files. The primary outcome was the proportion of women who opted for pessary management who later required prolapse surgery. Secondary outcomes included pessary complications and risk factors for failure. Kaplan-Meier survival estimates were performed to analyse pessary failure. RESULTS: Of the 218 women who presented with prolapse, 78% opted for pessary management, and pessary fitting was successful in 84%. Sixty-nine percent of women who opted for initial pessary management underwent surgery later, with a mean time from pessary insertion to surgery of 21.6 months. Vaginal erosions were reported in 42% of pessary users. Risk factors for pessary failure were younger age and previous history of hysterectomy or prolapse surgery. CONCLUSIONS: Although vaginal pessary use was the preferred first-line management choice for vaginal prolapse in most older women, surgery for prolapse was ultimately required in two-thirds of those conservatively managed. As three-quarters of older women presenting with prolapse had surgery as either a primary or secondary procedure; patients need to be advised of the high chance of requiring surgery at a later stage if they opt for pessary management.

Adverse events associated with pessary use over one year among women attending a pessary care clinic.

INTRODUCTION AND HYPOTHESIS: The primary objective was to determine the adverse event rate associated with pessary use. Secondary objectives were to determine discontinuation, patient satisfaction, and factors associated with adverse events. METHODS: A retrospective observational study included patients attending a nurse-led pessary clinic with ≥ 1 year follow-up. Patients were fitted with a pessary by a urogynecologist and pessary care by a nurse was performed every 3-4 months. Demographic characteristics, pessary fitting, adverse events, their management and discontinuation were recorded. Pearson Chi-square and Fisher exact tests assessed the association between predetermined risk factors and pessary complications or discontinuation. Relative risk and 95% confidence intervals were computed. RESULTS: 215 women were followed for a mean (standard deviation) of 4.4 (1.9) years. Mean age was 73.8 (8.7) years. Adverse event rate was 83.7%; most commonly vaginal discharge, vaginal bleeding and erosions. Women with cardiovascular risk factors were less likely to develop pessary-related adverse events (79.7% vs. 91.9%, p = 0.03). Gellhorn and donut pessaries were more commonly associated with pessary erosions than ring with support pessaries or incontinence rings (RR 2.37 [1.67; 3.38]). Thirty-five (16.3%) women discontinued pessary use at a mean of 3.3 (1.7) years after initial fitting. Having a pessary erosion was not associated with discontinuation (p = 0.698), but recurrent erosions were (p = 0.012). CONCLUSION: Adverse events were common among women continuing to use pessaries past 1 year, but adherence and satisfaction rates remained high after 4.4 years. Pessary type and absence of cardiovascular factors were associated with pessary-related adverse events.

The impact on complication rates of delayed routine pessary reviews during the COVID-19 pandemic.

INTRODUCTION AND HYPOTHESIS: During the COVID-19 pandemic, guidance was issued in the United Kingdom advising a delay in routine pessary reviews. The impact of this has not been fully explored. The null hypothesis for this study is that delayed routine pessary reviews during the COVID-19 pandemic did not result in a statistically significant increase in complication rate. METHODS: A retrospective comparative cohort study was conducted in NHS Tayside, Scotland, involving 150 patients pre-pandemic and 150 patients during the COVID-19 pandemic (before exclusions). Their notes were reviewed identifying age, care provider, pessary type, length of pessary usage, review date, time elapsed since the previous review, bleeding/infection/ulceration, removal issues, pessary replacement and outcome. Patients excluded were those with no pessary in situ at review, reviews at ≤4 months and >8 months (pre-pandemic) and reviews at ≤8 months (COVID-19 pandemic). RESULTS: The pre-pandemic group (n=106) had average review times of 10.1,6.2 and 6.2 months for cubes, rings and all others. Overall rates of bleeding/infection/ulceration; reported removal issues; and pessary subsequently not replaced were 9.4%, 11.3% and 5.7% respectively. The COVID-19 pandemic group (n=125) had average review times of 14.7, 10.8 and 11.4 months for cubes, rings and all others. Overall rates of bleeding/infection/ulceration; reported removal issues; and pessary subsequently not replaced were 21.6%, 16.0%, and 12.0% respectively. CONCLUSIONS: Overall, there was a significant increase in rates of bleeding/ulceration/infection (p=0.01). When individual pessaries were considered, this only remained true for rings (p=0.02). Our data would suggest that routine ring pessary reviews should not be extended beyond 6 months or risk bleeding/ulceration/infection.

Evaluating compliance and applicability of postpartum pessary use for preventing and treating pelvic floor dysfunction: a prospective multicenter study.

PURPOSE: Pelvic floor disorders are common and associated with pregnancy and childbirth. For restitution of pelvic floor connective tissue and thereby therapy of postpartum pelvic organ prolapse and stress urinary incontinence, the Restifem® pessary is approved. It supports the anterior vaginal wall behind the symphysis, the lateral sulci and the sacro-uterine ligaments and stabilises the connective tissue. We evaluated the compliance and applicability of Restifem® use in women postpartum in a preventive and therapeutic approach. METHODS: Restifem® pessary was handed out to 857 women. Six weeks after birth, they started the pessary use. After 8 weeks, 3 and 6 months postpartum, women received a questionnaire via online survey for evaluation of pessary applicability and efficacy. RESULTS: After 8 weeks, 209 women answered the questionnaire. 119 women used the pessary. Common problems were discomfort, pain and the pessary use was to circuitous. Vaginal infections were rare. After 3 months, 85 women and after 6 months, 38 women still used the pessary. 3 months postpartum, 94% of women with POP, 72% of women with UI and 66% of women with OAB stated to have an improvement of their symptoms using the pessary. 88% women without any disorder felt an improvement of stability. CONCLUSIONS: Use of the Restifem® pessary in the postpartum period is feasible and accompanied with less complications. It reduces POP and UI and leads to an increased sense of stability. So, Restifem® pessary can be offered to women postpartum to improve pelvic floor dysfunction.

Patient-reported goal achievements after pelvic floor muscle training versus pessary in women with pelvic organ prolapse. A randomised controlled trial.

The aim was to assess the achievement by self-determined goals in pelvic organ prolapse (POP) participants receiving pelvic floor muscle training (PFMT) compared to vaginal pessary. Forty participants with POP stage II to III were randomly allocated to pessary or PFMT. Participants were asked to list up 3 goals they expected from treatment. Thai version of Prolapse Quality of Life Questionnaire (P-QOL) and Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) were completed at 0 and 6-week period. At 6-week post-treatment, they were asked if their goals had been achieved. The totally achieved goals in the vaginal pessary group were 70% (14/20) significantly higher than PFMT group at 30% (6/20) (p = 0.01). The mean ± SD of the post-treatment P-QOL score in the vaginal pessary group was significantly lower than the PFMT group (13.90 ± 10.83 vs 22.04 ± 5.93, p = 0.01), but not different in all PISQ-IR subscales. Pessary treatment for POP yielded better total goal achievements and better quality of life than PFMT for POP treatment at a 6-week follow-up.Impact statementWhat is already known on this subject? Pelvic organ prolapse (POP) can severely affect the quality of life, causing physical, social, psychological, occupational, and/or sexual dysfunction. Individual patient goal setting and goal achievement scaling (GAS) offers a new method of patient-reported outcome measurement (PRO) in therapeutic success such as pessary or surgery in patient with POP. But there is no randomised controlled trial comparing pessary vs pelvic floor muscle training (PFMT) using GAS as the outcome measurement.What do the results of this study add? The results showed that women with POP stage II to III who received vaginal pessary had higher totally goal achievements and better quality of life than the women received the PFMT at 6-week follow up.What are the implications of these findings for clinical practice and/or further research? The information about the better goal achievements by using pessary can be used as the tools for counselling for patients with POP for selecting the choices for the treatment in the clinical setting.

POP stage II to III patients treatedwith vaginal pessary had higher totally goal achievements and better quality of life than treated by PFMT.

Arabin pessary to prevent adverse perinatal outcomes in twin pregnancies with a short cervix: a multicenter randomized controlled trial (PESSARONE).

BACKGROUND: The number of twin pregnancies continues to increase worldwide as both the number of pregnancies obtained by medically assisted reproduction and age at first pregnancy keep rising. Preterm delivery is the major complication associated with twin pregnancies. The effectiveness of preventive treatments such as progesterone or cervical cerclage for women with a short cervix is doubtful in twin pregnancies. The effectivity of cervical pessaries in preventing preterm birth and its associated morbidity and mortality is also controversial. OBJECTIVE: We sought to investigate if the Arabin pessary reduces adverse neonatal outcomes in twin pregnancies with a short cervix. STUDY DESIGN: This open-label, multicenter, randomized controlled trial on twin pregnancies with a cervical length of <35 mm compared pessary placement at 16+0 to 24+0 weeks' gestation with standard care alone. The primary endpoint was a composite of adverse neonatal outcomes, namely peripartum or neonatal death or significant neonatal morbidity before hospital discharge, defined as at least 1 of the following complications: bronchopulmonary dysplasia, intraventricular hemorrhage grade III to IV, periventricular leukomalacia, necrotizing enterocolitis grade II or higher, culture-proven sepsis, and retinopathy requiring treatment. A sample size of 308 pregnancies was planned to ensure 80% power to compare the proportions of women with at least 1 infant with an adverse neonatal outcome. The intention-to-treat analysis after multiple imputation of missing data, was supplemented with a secondary analysis that controlled for gestational age and cervical length, both at inclusion. The primary endpoint was also compared between randomization groups in the per-protocol population, which excluded patients with prespecified major protocol violations (mostly cervical cerclage and/or progesterone after inclusion). Secondary endpoints included preterm birth, spontaneous preterm birth, and pessary side effects. RESULTS: In total, 315 women were randomized to either receive a pessary (n=157) or standard management (n=158). Overall, 10.8% (34 women) of participants had a missing value for the primary endpoint, mostly (79%) because of the lack of paternal consent for neonatal data collection. In the intention-to-treat analysis, the adverse neonatal outcome occurred in 16.8% of the pessary group vs in 22.5% of the control group (risk ratio, 0.69; 95% confidence interval, 0.39-1.23; P=.210). The per-protocol analysis did not show any significant difference between groups (risk ratio, 0.78; 95% confidence interval, 0.47-1.28; P=.320). The occurrence of preterm birth or spontaneous preterm birth did not differ significantly between groups. No serious side effects were associated with pessary use. CONCLUSION: Pessary use in our study did not significantly reduce adverse neonatal outcomes in twin pregnancies with a short cervix.

Cervical pessary for preventing preterm birth in singleton pregnancies.

BACKGROUND: Preterm birth (PTB), defined as birth prior to 37 weeks of gestation, occurs in ten percent of all pregnancies. PTB is responsible for more than half of neonatal and infant mortalities and morbidities. Because cervical insufficiency is a common cause of PTB, one possible preventive strategy involves insertion of a cervical pessary to support the cervix. Several published studies have compared the use of pessary with different management options and obtained questionable results. This highlights the need for an up-to-date systematic review of the evidence. OBJECTIVES: To evaluate the benefits and harms of cervical pessary for preventing preterm birth in women with singleton pregnancies and risk factors for cervical insufficiency compared to no treatment, vaginal progesterone, cervical cerclage or bedrest. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform to 22 September 2021. We also searched the reference lists of included studies for additional records. SELECTION CRITERIA: We included published and unpublished randomised controlled trials (RCTs) comparing cervical pessary with no treatment, vaginal progesterone, cervical cerclage or bedrest for preventing PTB. We excluded quasi-randomised trials. Our primary outcome was delivery before 34 weeks' gestation. Our secondary outcomes were 1. delivery before 37 weeks' gestation, 2. maternal mortality, 3. maternal infection or inflammation, 4. preterm prelabour rupture of membranes, 5. harm to woman from the intervention, 6. maternal medications, 7. discontinuation of the intervention, 8. maternal satisfaction, 9. neonatal/paediatric care unit admission, 10. fetal/infant mortality, 11. neonatal sepsis, 12. gestational age at birth, 13. harm to offspring from the intervention 14. birthweight, 15. early neurodevelopmental morbidity, 15. late neurodevelopmental morbidity, 16. gastrointestinal morbidity and 17. respiratory morbidity. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for eligibility and risk of bias, evaluated trustworthiness based on criteria developed by the Cochrane Pregnancy and Childbirth Review Group, extracted data, checked for accuracy and assessed certainty of evidence using the GRADE approach. MAIN RESULTS: We included eight RCTs (2983 participants). We included five RCTs (1830 women) in the comparison cervical pessary versus no treatment, three RCTs (1126 pregnant women) in the comparison cervical pessary versus vaginal progesterone, and one study (13 participants) in the comparison cervical pessary versus cervical cerclage. Overall, the certainty of evidence was low to moderate due to inconsistency (statistical heterogeneity), imprecision (few events and wide 95% confidence intervals (CIs) consistent with possible benefit and harm), and risk of performance and detection bias. Cervical pessary versus no treatment Cervical pessary compared with no treatment may reduce the risk of delivery before 34 weeks (risk ratio (RR) 0.72, 95% CI 0.33 to 1.55; 5 studies, 1830 women; low-certainty evidence) or before 37 weeks (RR 0.68, 95% CI 0.44 to 1.05; 5 studies, 1830 women; low-certainty evidence). However, these results should be viewed with caution because the 95% CIs cross the line of no effect. Cervical pessary compared with no treatment probably has little or no effect on the risk of maternal infection or inflammation (RR 1.04, 95% CI 0.87 to 1.26; 2 studies, 1032 women; moderate-certainty evidence). It is unclear if cervical pessary compared with no treatment has an effect on neonatal/paediatric care unit admission (RR 0.96, 95% CI 0.58 to 1.59; 3 studies, 1332 infants; low-certainty evidence) or fetal/neonatal mortality (RR 0.93, 95% CI 0.58 to 1.48; 5 studies, 1830 infants; low-certainty evidence) because the 95% CIs are compatible with a wide range of effects that encompass both appreciable benefit and harm. Cervical pessary versus vaginal progesterone Cervical pessary may reduce the risk of delivery before 34 weeks (RR 0.72, 95% CI 0.52 to 1.02; 3 studies, 1126 women; moderate-certainty evidence) or before 37 weeks (RR 0.89, 95% CI 0.73 to 1.09; 3 studies, 1126 women; moderate-certainty evidence), but we are uncertain of the results because the 95% CI crosses the line of no effect. The intervention probably has little or no effect on maternal infection or inflammation (RR 0.95, 95% CI 0.81 to 1.12; 2 studies, 265 women; moderate-certainty evidence). It is unclear if cervical pessary compared with vaginal progesterone has an effect on the risk of neonatal/paediatric care unit admission (RR 0.98, 95% CI 0.49 to 1.98; low-certainty evidence) or fetal/neonatal mortality (RR 1.97, 95% CI 0.50 to 7.70; 2 studies; 265 infants; low-certainty evidence) because the 95% CIs are compatible with a wide range of effects that encompass both appreciable benefit and harm. Cervical pessary versus cervical cerclage Only one very small study of 13 pregnant women contributed data to this comparison; the results were unclear. AUTHORS' CONCLUSIONS: In women with a singleton pregnancy, cervical pessary compared with no treatment or vaginal progesterone may reduce the risk of delivery before 34 weeks or 37 weeks, although these results should be viewed with caution due to uncertainty around the effect estimates. There is insufficient evidence with regard to the effect of cervical pessary compared with cervical cerclage on PTB. Due to low certainty-evidence in many of the prespecified outcomes and non-reporting of several other outcomes of interest for this review, there is a need for further robust RCTs that use standardised terminology for maternal and offspring outcomes. Future trials should take place in a range of settings to improve generalisability of the evidence. Further research should concentrate on comparisons of cervical pessary versus cervical cerclage and bed rest. Investigation of different phenotypes of PTB may be relevant.

Parameters associated with unsuccessful pessary fitting for pelvic organ prolapse up to three months follow-up: a systematic review and meta-analysis.

OBJECTIVES: To clarify which parameters are associated with unsuccessful pessary fitting for pelvic organ prolapse (POP) at up to 3 months follow-up. METHODS: Embase, PubMed and Cochrane CENTRAL library were searched in May 2020. Inclusion criteria were: (1) pessary fitting attempted in women with symptomatic POP; (2) pessary fitting success among the study outcomes with a maximal follow-up of 3 months; (3) baseline parameters compared between successful and unsuccessful group. A meta-analysis was performed using the random effects model. MAIN RESULTS: Twenty-four studies were included in the meta-analysis. Parameters associated with unsuccessful pessary fitting were: age (OR 0.70, 95% CI 0.56-0.86); BMI (OR 1.35, 95% CI 1.08-1.70); menopause (OR 0.65 95% CI 0.47-0.88); de novo stress urinary incontinence (OR 5.59, 95% CI 2.24-13.99); prior surgery, i.e. hysterectomy (OR 1.88, 95% CI 1.48-2.40), POP surgery (OR 2.13, 95% CI 1.34-3.38), pelvic surgery (OR 1.81, 05% CI 1.01-3.26) and incontinence surgery (OR 1.87, 95% CI 1.08-3.25); Colorectal-Anal Distress Inventory-8 scores (OR 1.92, 95% CI 1.22-3.02); solitary predominant posterior compartment POP (OR 1.59, 95% CI 1.08-2.35); total vaginal length (OR 0.56, 95% CI 0.32-0.97); wide introitus (OR 4.85, 95% CI 1.60-14.68); levator ani avulsion (OR 2.47, 95% CI 1.35-4.53) and hiatal area on maximum Valsalva (OR 1.89, 95% CI 1.27-2.80). CONCLUSION: During counselling for pessary treatment a higher risk of failure due to the aforementioned parameters should be discussed and modifiable parameters should be addressed. More research is needed on the association between anatomical parameters and specific reasons for unsuccessful pessary fitting.

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.

Do vaginal pessaries used to treat pelvic organ prolapse impact on sexual function? A systematic review and meta-analysis.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse (POP) is common and associated with sexual dysfunction. Vaginal pessaries are an effective treatment for POP, but their impact on sexual function is not well established. The aim of this systematic review and meta-analysis was to establish the impact of vaginal pessaries used for POP on female sexual function. METHODS: Systematic review of the literature following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and checklist. A comprehensive search was conducted across Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews, EMBASE, MEDLINE, CINAHL, ClinicalTrials.gov , The WHO International Clinical Trials Registry Platform, ProQuest Dissertations & Theses, Open Grey and Scopus Citation Database. Randomised controlled trials and cohort studies that assessed sexual function in women pre- and post-pessary treatment for POP were included, assessed for risk of bias and their results synthesised. RESULTS: A total of 1,945 titles and abstracts were screened, 104 full-text articles were assessed for eligibility, 14 studies were included in the narrative analysis and 7 studies were included in the meta-analysis. The results suggest that, in sexually active women, there is no evidence of a deterioration in sexual function and some evidence of an improvement. DISCUSSION: This review offers reassurance that in sexually active women who successfully use a pessary for treatment of their prolapse, there is no deterioration in sexual function. There is some evidence of an improvement in sexual function, but given the clinical heterogeneity in the studies included, caution should be taken in generalising these findings.

Host inflammatory response in women with vaginal epithelial abnormalities after pessary use.

BACKGROUND: Vaginal epithelial abnormalities (VEA) are a common complication associated with pessary use. The objective of this study was to determine if there is a host pro-inflammatory response associated with pessary use and VEA. METHODS: Patients wearing pessaries for at least two weeks for the management of pelvic organ prolapse and/or urinary incontinence were screened for eligibility. Vaginal swabs were collected from women with VEA (cases) and without VEA (controls). Cases were matched to controls in a 1:3 ratio. Cytokine analysis of the collected samples was performed using multiplex analysis to determine the concentrations of interleukin (IL)6, interferon alpha 2 (IFNα2), tumor necrosis factor alpha (TNFα) and IL1ß. A cross-sectional analysis was performed, comparing vaginal cytokine concentrations in women with and without VEA. RESULTS: We enrolled 211 patients in this analysis: 50 cases and 161 controls. The median concentrations (pg/mL) of the four cytokines for cases and controls respectively were; IL6: 6.7 (IQR <2.9 [the lower limit of detection, LLD]-14.2) and < 2.9 (LLD) (IQR <2.9 [LLD]-5.5), IFNα2: 8.2 (IQR 6.1-13.9) and 7.9 (IQR 3.9-13.6), TNFα: 15.2 (IQR 6.1-30.4) and 4.68 (IQR <2.3 [LLD]-16.3), IL1ß 195.7 (IQR 54.5-388.6) and 38.5 (IQR 6.7-154.9). The differences in median cytokine levels were statistically higher in cases for IL6, TNFα, and IL1ß (all p < 0.001) compared to controls. Older age (OR: 1.062, 95% CI, 1.015-1.112), lower BMI (OR: 0.910, 95% CI, 0.839-0.986) and presence of VEA at last check (OR: 5.377, 95% CI, 2.049-14.108) were associated with higher odds of having VEA on multivariate analysis. CONCLUSION: Pro-inflammatory cytokines, specifically IL6, TNFα, and IL1ß, are elevated in pessary-wearing patients who have VEA. Additional prospective studies are needed to assess baseline vaginal inflammatory profiles before and after pessary placement to understand VEA formation in pessary patients.

Effect of vaginal estrogen in postmenopausal women using vaginal pessary for pelvic organ prolapse treatment: a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: Evidence and recommendations for the use of intravaginal estrogen for prevention of bacterial vaginosis and pessary-related complications are limited and controversial. We hypothesized that adding intravaginal estrogen to pessary use would decrease the incidence of bacterial vaginosis and other pessary-related complications. METHODS: A single-center, open-label, randomized, parallel study was conducted between April 2018 and August 2020. Participants were randomized to either receive intravaginal estriol 0.03 mg plus Lactobacillus acidophilus 100 million viable cell vaginal tablets or have no treatment. The Amsel criteria, normal flora index, visual analog scale, Thai version of the ICIQ-VS (International Consultation on Incontinence Questionnaire-Vaginal symptoms) questionnaire, vaginal abrasions and vaginal bleeding were evaluated at entry and at 2- and 14-week follow-up. RESULTS: Seventy-eight women were included and randomized to two groups (39 women per group). At 2-week follow-up, one participant in the intervention group and two participants in the control group were diagnosed with bacterial vaginosis (2.7% vs. 5.7%, p = 0.609). At 14-week follow-up, two participants in the intervention group and two participants in the control group were diagnosed with bacterial vaginosis (5.7% vs. 6.2%, p = 0.926). Normal flora index was significantly different at 2-week follow-up [8 (6.3) vs. 5 (6.0), p = 0.032]. There was no significant difference in the visual analog scale, Thai version of the ICIQ-VS, vaginal abrasions and vaginal bleeding between the 2- and 14-week follow-ups. CONCLUSIONS: This study shows no benefit of intravaginal estrogen in reducing bacterial vaginosis, vaginal abrasions, vaginal bleeding and pain in postmenopausal women using a vaginal pessary for pelvic organ prolapse treatment.

Effect of estrogen on vaginal complications of pessary use: a systematic review and meta-analysis.

OBJECTIVE: We aimed to systematically review the impact of local estrogen use in combination with a pessary on vaginal complications in postmenopausal women with pelvic organ prolapse (POP). METHODS: We searched databases including Medline, Embase, PubMed, Clinical Trials and the Cochrane Central Register of Controlled Trials for relevant literature published in English from inception to 31 May 2021. Only randomized controlled trials (RCTs) and cohort studies were included. RESULTS: In total, five studies were included (three RCTs, one prospective study and one retrospective cohort study). The meta-analysis was performed with subgroups. Our results indicated a significantly lower incidence of bacterial vaginosis (BV) among postmenopausal women who used estrogen than among controls, with a total pooled odds ratio (OR) of 0.29 (95% confidence interval [CI]: 0.11-0.72; I2 = 38%; p = 0.008). The summary ORs of the estrogen use group were 0.98 (95% CI: 0.59-1.63; I2 = 41%; p = 0.95) for vaginal ulceration, 0.80 (95% CI: 0.42-1.54; I2 = 29%; p = 0.50) for vaginal bleeding and 0.74 (95% CI: 0.35-1.58; I2 = 35%; p = 0.44) for vaginal discharge. CONCLUSIONS: Local estrogen in combination with a pessary could decrease the BV rate among postmenopausal women with POP. However, consensus regarding the value of estrogen use for decreasing other pessary complications has not yet been reached. Additional multicenter RCTs with large sample sizes should be conducted to better understand the effect of estrogen use on reducing pessary-related complications.

Novel, disposable, self-inserted, vaginal device for the non-surgical management of pelvic organ prolapse: efficacy, safety, and quality of life.

BACKGROUND: We evaluated a novel disposable, collapsible, ring-shaped vaginal device that is self-inserted within an applicator and removed with a string. The device was developed to overcome the drawbacks of existing ring pessaries for non-surgical pelvic organ prolapse management (POP). METHODS: The primary objective efficacy endpoint of this prospective, interventional, multicenter, self-controlled, and home-use study was the proportion of subjects with improved staging on the Pelvic Organ Prolapse Quantification (POP-Q) scale. Subjective efficacy was assessed using the POP symptoms alleviation score. Safety was evaluated by recording the rate and incidence of adverse events (AEs) in a daily diary, and quality of life (QoL) was evaluated using the modified Pelvic Floor Impact (PFIQ-7) and Pelvic Floor Disability Index (PFDI-20) questionnaires. RESULTS: A total of 94 usage cycles were observed in a group of 52 participants (mean age 60.2 ± 10.5 years, 81.1% postmenopausal) who used the device for 3558 days. Of these, 24 participants completed one usage cycle, 14 completed two usage cycles, and 14 completed three usage cycles with 28-45 days of ProVate use in each usage cycle. All patients experienced greater than two POP-Q stage reductions. The descent was completely reduced to POP-Q stage 0 in 97.8% of participants. The POP symptom alleviation questionnaire showed significant subjective efficacy (P < 0.0001). The modified PFDI-20 and PFIQ-7 scores also improved substantially (P < 0.0001 for both). There were 91 nonserious device-related AEs: 98.9% were mild and 87.9% anticipated, with no vaginal infection, and one case of urinary tract infection. CONCLUSION: The novel device substantially reduces prolapse and provides significant subjective POP symptom relief and QoL improvement, with minimal AEs. The device may enable women to self-manage their prolapse with a small, disposable device that minimizes self-touching and frequent dependency on the clinic. TRIAL REGISTRATION: Clinical. TRIALS: gov , NCT02239133 , posted September 12, 2014 (retrospectively registered).