Comparing cervical cerclage, pessary and vaginal progesterone for prevention of preterm birth in women with a short cervix (SuPPoRT): A multicentre randomised controlled trial.

BACKGROUND: Cervical cerclage, cervical pessary, and vaginal progesterone have each been shown to reduce preterm birth (PTB) in high-risk women, but to our knowledge, there has been no randomised comparison of the 3 interventions. The SuPPoRT "Stitch, Pessary, or Progesterone Randomised Trial" was designed to compare the rate of PTB <37 weeks between each intervention in women who develop a short cervix in pregnancy. METHODS AND FINDINGS: SuPPoRT was a multicentre, open label 3-arm randomised controlled trial designed to demonstrate equivalence (equivalence margin 20%) conducted from 1 July 2015 to 1 July 2021 in 19 obstetric units in the United Kingdom. Asymptomatic women with singleton pregnancies with transvaginal ultrasound cervical lengths measuring <25 mm between 14+0 and 23+6 weeks' gestation were eligible for randomisation (1:1:1) to receive either vaginal cervical cerclage (n = 128), cervical pessary (n = 126), or vaginal progesterone (n = 132). Minimisation variables were gestation at recruitment, body mass index (BMI), and risk factor for PTB. The primary outcome was PTB <37 weeks' gestation. Secondary outcomes included PTB <34 weeks', <30 weeks', and adverse perinatal outcome. Analysis was by intention to treat. A total of 386 pregnant women between 14+0 and 23+6 weeks' gestation with a cervical length <25 mm were randomised to one of the 3 interventions. Of these women, 67% were of white ethnicity, 18% black ethnicity, and 7.5% Asian ethnicity. Mean BMI was 25.6. Over 85% of women had prior risk factors for PTB; 39.1% had experienced a spontaneous PTB or midtrimester loss (>14 weeks gestation); and 45.8% had prior cervical surgery. Data from 381 women were available for outcome analysis. Using binary regression, randomised therapies (cerclage versus pessary versus vaginal progesterone) were found to have similar effects on the primary outcome PTB <37 weeks (39/127 versus 38/122 versus 32/132, p = 0.4, cerclage versus pessary risk difference (RD) -0.7% [-12.1 to 10.7], cerclage versus progesterone RD 6.2% [-5.0 to 17.0], and progesterone versus pessary RD -6.9% [-17.9 to 4.1]). Similarly, no difference was seen for PTB <34 and 30 weeks, nor adverse perinatal outcome. There were some differences in the mild side effect profile between interventions (vaginal discharge and bleeding) and women randomised to progesterone reported more severe abdominal pain. A small proportion of women did not receive the intervention as per protocol; however, per-protocol and as-treated analyses showed similar results. The main study limitation was that the trial was underpowered for neonatal outcomes and was stopped early due to the COVID-19 pandemic. CONCLUSIONS: In this study, we found that for women who develop a short cervix, cerclage, pessary, and vaginal progesterone were equally efficacious at preventing PTB, as judged with a 20% equivalence margin. Commencing with any of the therapies would be reasonable clinical management. These results can be used as a counselling tool for clinicians when managing women with a short cervix. TRIAL REGISTRATION: EU Clinical Trials register. EudraCT Number: 2015-000456-15, clinicaltrialsregister.eu., ISRCTN Registry: ISRCTN13364447, isrctn.com.

Luteal phase support using micronized vaginal progesterone as pessaries or capsules in artificial cycles: is there any difference?

RESEARCH QUESTION: Is there a difference between the proportion of patients with serum progesterone <8.8 ng/ml on the day of embryo transfer when micronized vaginal progesterone (MVP) for luteal phase support (LPS) is given as pessaries versus capsules? DESIGN: This retrospective, matched-cohort, single-centre study compared pessaries (Cyclogest) versus capsules (Utrogestan, Progeffik) for LPS in hormone replacement treatment-embryo transfer (HRT-ET) cycles. Patients under 50 years old with a triple-layer endometrial thickness of ≥6.5 mm underwent transfer of one or two blastocysts. Serum progesterone concentrations were measured on the day of transfer; patients with concentrations <8.8 ng/ml received a single 'rescue' dose of additional progesterone by subcutaneous injection. RESULTS: In total 2665 HRT-ET cycles were analysed; 663 (24.9%) used pessaries for LPS and 2002 (75.1%) used capsules. Mean serum progesterone concentrations with standard deviations on the day of embryo transfer were significantly higher in the group using MVP pessaries compared with those using capsules (14.5 ± 5.1 versus 13.0 ± 4.8 ng/ml; P = 0.000). The percentage of participants with suboptimal serum progesterone concentrations on the day of embryo transfer (<8.8 ng/ml) was significantly lower in the pessary group than the capsule group (10.3%, 95% confidence interval [CI] 7.9-12.6% versus 17.9%, 95% CI 16.2-19.6%; adjusted odds ratio 0.426, 95% CI 0.290-0.625; P = 0.000). No differences in pregnancy outcome were observed between the groups. CONCLUSIONS: Using MVP pessaries rather than capsules for LPS resulted in significantly fewer patients having suboptimal serum progesterone concentrations on the day of embryo transfer. Consequently, almost 50% fewer patients in the pessary group needed rescue treatment.

Effectiveness and safety of a novel, collapsible pessary for management of pelvic organ prolapse.

BACKGROUND: Pessaries are an effective treatment for pelvic organ prolapse, yet currently available pessaries can cause discomfort during removal and insertion. An early feasibility trial of an investigational, collapsible pessary previously demonstrated mechanical feasibility during a brief 15-minute office trial. Longer-term, patient-centered safety and efficacy data are needed. OBJECTIVE: This study aimed to assess the effectiveness and safety of the investigational vaginal pessary for pelvic organ prolapse at 3 months. STUDY DESIGN: This was a prospective, 7-center, open-label equivalence study with participants serving as their own controls. Subjects were current users of a Gellhorn or ring pessary with ≥stage 2 prolapse. Subjective and objective data were collected at baseline for 1 month while subjects used their current pessary. Data were then collected throughout a 3-month treatment phase with the study pessary. The primary outcome was change in Pelvic Floor Distress Inventory-20 score. Secondary outcome measures included objective assessment of prolapse support, changes in the Pelvic Floor Impact Questionnaire-7, and pain with insertion and removal, measured using a visual analog scale. Data from subjects fitted with the study pessary were analyzed using an intention-to-treat approach, and those who dropped out were assigned scores at the upper limit of the predefined equivalence limits. Secondary per protocol analyses included subjects who completed treatment. The study was powered to 80% with a minimal important change equivalence limit of 18.3 points on the Pelvic Floor Distress Inventory-20 scale. Square root transformations were used for nonparametric data, and P values were adjusted for multiple comparisons. RESULTS: A total of 78 subjects were enrolled, however, 16 withdrew before study pessary placement. The study pessary was fitted in 62 subjects (50 ring and 12 Gellhorn pessary users), and 48 (62%) completed the 3-month intervention. The change in Pelvic Floor Distress Inventory-20 scores at 3 months demonstrated equivalence when compared with the subjects' baseline scores (mean difference, -3.96 [improvement]; 90% confidence interval, -11.99 to 4.08; P=.002). Among those completing study, the Pelvic Floor Distress Inventory-20 scores, equivalence was not demonstrated and scores favored the study pessary (mean difference, -10.45; 90% confidence interval, -20.35 to 0.54; P=.095). Secondary outcomes included objective measures of support, which were similar (mean difference: Ba, 0.54 cm; Bp, 0.04 cm, favoring study pessary; improvement in mean Pelvic Floor Impact Questionnaire-7 scores for those who completed the trial: before, 32.23; after, 16.86; P=.019), and pain with insertion and removal, which was lower with the study pessary than with the subject's own pessary (mean difference visual analog scale score insertion, 9.91 mm; P=.019; removal, 11.23 mm; P=.019). No serious adverse events related to the pessary were reported. CONCLUSION: Equivalence was demonstrated in the primary outcome of the study pessary when compared with current, noncollapsible pessaries in terms of change in severity and bother of pelvic floor symptoms. Among participants who completed the trial, the Pelvic Floor Impact Questionnaire-7 improved with study pessary use and change in Pelvic Floor Distress Inventory-20 scores were nonequivalent, favoring the study pessary. Subjects reported significantly lower pain scores with both pessary insertion and removal with the novel collapsible pessary when compared with their standard pessary.

SMFM Consult Series #70: Management of short cervix in individuals without a history of spontaneous preterm birth.

Most deliveries before 34 weeks of gestation occur in individuals with no previous history of preterm birth. Midtrimester cervical length assessment using transvaginal ultrasound is one of the best clinical predictors of spontaneous preterm birth. This Consult provides guidance for the diagnosis and management of a short cervix in an individual without a history of preterm birth. The following are Society for Maternal-Fetal Medicine recommendations: (1) we recommend that all cervical length measurements used to guide therapeutic recommendations be performed using a transvaginal approach and in accordance with standardized procedures as described by organizations such as the Perinatal Quality Foundation or the Fetal Medicine Foundation (GRADE 1C); (2) we recommend using a midtrimester cervical length of ≤25 mm to diagnose a short cervix in individuals with a singleton gestation and no previous history of spontaneous preterm birth (GRADE 1C); (3) we recommend that asymptomatic individuals with a singleton gestation and a transvaginal cervical length of ≤20 mm diagnosed before 24 weeks of gestation be prescribed vaginal progesterone to reduce the risk of preterm birth (GRADE 1A); (4) we recommend that treatment with vaginal progesterone be considered at a cervical length of 21 to 25 mm based on shared decision-making (GRADE 1B); (5) we recommend that 17-alpha hydroxyprogesterone caproate, including compounded formulations, not be prescribed for the treatment of a short cervix (GRADE 1B); (6) in individuals without a history of preterm birth who have a sonographic short cervix (10-25 mm), we recommend against cerclage placement in the absence of cervical dilation (GRADE 1B); (7) we recommend that cervical pessary not be placed for the prevention of preterm birth in individuals with a singleton gestation and a short cervix (GRADE 1B); and (8) we recommend against routine use of progesterone, pessary, or cerclage for the treatment of cervical shortening in twin gestations outside the context of a clinical trial (GRADE 1B).

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.

Cost-Effectiveness of 2 Models of Pessary Care for Pelvic Organ Prolapse: Findings From the TOPSY Randomized Controlled Trial.

OBJECTIVES: Pelvic organ prolapse is the descent of one or more reproductive organs from their normal position, causing associated negative symptoms. One conservative treatment option is pessary management. This study aimed to to investigate the cost-effectiveness of pessary self-management (SM) when compared with clinic-based care (CBC). A decision analytic model was developed to extend the economic evaluation. METHODS: A randomized controlled trial with health economic evaluation. The SM group received a 30-minute SM teaching session, information leaflet, 2-week follow-up call, and a local helpline number. The CBC group received routine outpatient pessary appointments, determined by usual practice. The primary outcome for the cost-effectiveness analysis was incremental cost per quality-adjusted life year (QALY), 18 months post-randomization. Uncertainty was handled using nonparametric bootstrap analysis. In addition, a simple decision analytic model was developed using the trial data to extend the analysis over a 5-year period. RESULTS: There was no significant difference in the mean number of QALYs gained between SM and CBC (1.241 vs 1.221), but mean cost was lower for SM (£578 vs £728). The incremental net benefit estimated at a willingness to pay of £20 000 per QALY gained was £564, with an 80.8% probability of cost-effectiveness. The modeling results were consistent with the trial analysis: the incremental net benefit was estimated as £4221, and the probability of SM being cost-effective at 5 years was 69.7%. CONCLUSIONS: Results suggest that pessary SM is likely to be cost-effective. The decision analytic model suggests that this result is likely to persist over longer durations.

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.

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.

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.

The Role of Self-Management in Pessary Therapy for Pelvic Organ Prolapse-A retrospective cohort study.

INTRODUCTION AND HYPOTHESIS: This study investigated pessary self-management (PSM). The primary outcome was how often PSM was taught to patients with pelvic organ prolapse (POP). Secondary outcomes were associations of PSM with treatment continuation, side effects, changing to surgery, and number of doctor consultations in the first year after treatment initiation compared with clinical management (CM). METHODS: A retrospective cohort study was conducted in 300 patients visiting three Dutch medical centres in 2019, and receiving a pessary for POP. The t test, Chi-squared test and logistic regression were performed to compare PSM with CM and to identify factors associated with treatment continuation. RESULTS: A total of 35% of patients received PSM instructions, of which 92% were able to perform PSM successfully. Treatment was continued by 83% of patients practicing PSM and 75% of patients having CM (p = 0.16), side effects occurred in 26% and 39% respectively (p = 0.18). Pain or discomfort was associated with treatment discontinuation (p < 0.01). In a subgroup analysis of patients who had a pessary suitable for PSM, treatment continuation was significantly higher in the PSM group (97%) than in the CM group (74%; p < 0.01). CONCLUSIONS: Pessary self-management was only taught to 35% of patients who received a pessary, although the ability to perform PSM was high (92%). Treatment discontinuation was significantly lower in the PSM subgroup, when assessing the subgroup of patients using a pessary suitable for PSM. The large number of patients using a pessary suitable for PSM in the CM group implies that there is a lot to gain by promoting PSM.

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 Compliance of Self-Care Pessary in Symptomatic Pelvic Organ Prolapse.

INTRODUCTION AND HYPOTHESIS: Continuation of using a pessary for the treatment of pelvic organ prolapse (POP) is important for improving symptoms but the data on long-term compliance is very limited. Therefore, we conducted this study aimed at evaluating the compliance of patients in the long-term use of a pessary. METHODS: The medical records of women with symptomatic POP were retrospectively reviewed to recruit cases opting for pessary use. The inclusion criteria were women who had a successful pessary fitting and completed at least 5 years of follow-up. Exclusion criteria were pregnancy, death during the follow-up period, and loss to follow-up. Demographic data, pelvic organ prolapse stage, associated symptoms, type and size of pessary, and reason for discontinuation were reviewed. RESULTS: A total of 261 patients opted for pessary use. Of them, 88.9% (231 out of 261) were successful in initial pessary fitting and 54 were excluded for various reasons. The remaining 178 patients were available for analysis. The continuation rate of self-care pessary at the 5-year follow-up was 53.93% (96). The discontinuation rate was 46.07% (82). The main reasons for discontinuation were desire for surgery (39.1%) and discomfort (31.7%). The highest rate of discontinuation (46.63%) was found in the 1st year of follow-up. The significant risk factors of discontinuation included digitation symptoms on univariate analysis and prior hysterectomy on multivariate analysis, with an odds ratio (95% CI) of 5.98 (1.56-22.88). CONCLUSIONS: Among Thai women, the adherence to self-care pessary in symptomatic pelvic organ prolapse at the 5-year follow-up was 53.93%. The main reason for discontinuation was a prior hysterectomy.

Understanding Factors That Affect Willingness to Self-Manage a Pessary for Pelvic Organ Prolapse: A Questionnaire-Based Cross-Sectional Study of Pessary-Using Women in the UK.

INTRODUCTION AND HYPOTHESIS: Pessary self-management offers benefits to women with no increased risk of complications. However, many are unwilling to self-manage, preferring clinician-led care. This study is aimed at exploring factors associated with willingness to self-manage a pessary. METHODS: Women attending pessary clinic at a UK hospital were asked to complete a questionnaire providing responses on pessary use, comorbidities, female genital self-image, self-management experience and willingness (or not) to learn self-management. Based upon statistical advice we aimed to recruit 90 women. Data were analysed using the non-parametric Kruskal-Wallis test and Chi-squared test. Free text data were analysed thematically. RESULTS: A total of 89 women completed the questionnaire. Thirty-three women (38%) had previously been taught pessary self-management. Of the remaining women, 12 (21%) were willing to learn, 28 (50%) were not willing and 16 (29%) were unsure. There was no correlation between female genital self-image and willingness to self-manage a pessary. Younger women were more willing to learn self-management (p = < 0.001). Willing women were motivated by reduced follow-up visits. Self-managing women reported benefits including increased autonomy, cleanliness and giving their body "a break". Reasons discouraging women from self-managing were a lack of confidence; feeling physically unable; wanting clinician-led care; fear of problems or previous problems with their pessary. CONCLUSIONS: Most women were either unsure about pessary self-management or unwilling to self-manage. Age was the only factor we found that had a significant relationship with willingness to self-manage a pessary. With robust self-management teaching, support and follow-up, it is likely that many of the barriers women report can be overcome.

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.

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.

Self-care of vaginal pessary for pelvic organ prolapse: a systematic review and meta-analysis.

INTRODUCTION: There is no evidence about the efficacy of self-care of vaginal pessary in women with symptomatic pelvic organ prolapse (POP). The aim of this systematic review and meta-analysis is to assess the adherence to pessary treatment among women who engage in self-management of their pessary. METHODS: We performed a systematic review and meta-analysis, according to PRISMA 2020 guidelines, and selected seven publications for inclusion in the analysis. RESULTS: Pooled continuation rate of self-cared vaginal pessary was the 76% (95%CI: 66-85%) with a I2-test of 93.3% (p < 0.001). Pooled conversion to POP surgery was the 12% (95%CI: 1-23%) with a I2-test of 96% (p < 0.001). Continuation rate was not statistically different between women who were treated by self-care and non-self-care management of vaginal pessary (RR 1.11, 95%CI 0.96-1.27; p = 0.15), with a related I2-test of 37% (p = 0.21). CONCLUSION: Self-care vaginal pessary management presented a high continuation rate in women affected by pelvic organ prolapse at a long follow-up. The rate of conversion to surgical management of POP was low. No significant difference in continuation rate were highlighted between women who adopted the self-care or the clinical-based management of pessary.

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.

The influence of decisional conflict on treatment decision in pelvic organ prolapse-data from the SHADE-POP trial.

PURPOSE: Women with symptomatic pelvic organ prolapse are facing the choice between several treatment options and a potentially difficult decision. The aim of this study was to examine the effect of decisional conflict, patient characteristics and other decision-related factors on treatment decision in women with pelvic organ prolapse. METHODS: Data from the SHADE-POP trial were used. Women with symptomatic pelvic organ prolapse who visited their gynaecologist for (new) treatment options were included. In all participants, demographical characteristics and validated questionnaires concerning decisional conflict (DCS), shared decision making (SDM-Q-9), information provision (SCIP-B), anxiety and depression (HADS) and satisfaction with care (PSQ-18) were collected 2 weeks after the visit. Analyses were performed using univariate and multivariate linear and logistic regression analyses. RESULTS: Ninety six women with pelvic organ prolapse facing a treatment decision were included. An increase in decisional conflict as experienced by patients was related to the choice of more conservative treatment, such as pelvic floor muscle training or pessary, instead of surgery (p = 0.02). Shared decision making, better information provision and satisfaction with care were related to lower levels of decisional conflict (p = 0.001). CONCLUSION: Decisional conflict in women with pelvic organ prolapse favours conservative treatment instead of surgery. Gaining knowledge on the effect of decisional conflict, patient characteristics and other decision-related factors on treatment decision in pelvic organ prolapse will be a step towards a better-guided treatment decision and better patient-reported outcomes for this group of patients. NL 55737.028.15, 30-10-2016.

Prediction of Preterm Birth with the Uterocervical Angle in Singleton Pregnancies Treated with a Cervical Pessary.

BACKGROUND: Cervical pessaries are an established therapy option for patients at risk for spontaneous preterm birth (sPTB). The uterocervical angle (UCA) remains a promising sPTB predictor. However, its clinical significance has yet to be described in patients treated with a pessary. METHODS: This study analyzed data of patients treated with a pessary because of cervical shortening in singleton pregnancies. The patients were divided into 2 groups according to transvaginal ultrasound findings: the funneling group (n = 68) and the no-funneling group (n = 42). Moreover, we analyzed patients within these prespecified groups according to the UCA < 95° and ≥ 95°. RESULTS: Delivery occurred significantly earlier in patients treated with a pessary and with a high UCA ≥ 95°(p = 0.006). The median gestational age at delivery in patients treated with a pessary and with no funneling and a UCA < 95° vs. ≥ 95° were 39.00 and 36.14 weeks, respectively (p = 0.005). In cases with funneling and a UCA < 95° vs. ≥ 95° the mean gestational age at delivery was 38.14 and 38.07 weeks respectively (p=1,00). There was a significant negative linear correlation between UCA and the gestational age at delivery in all patients (p = 0.04), which was even profound in the group without funneling (p = 0.0002). However, we found no significant correlation between cervical length and gestational age at delivery in all patients (p = 0.42) as well as in the group without funneling (p = 0.28). CONCLUSION: In spite of pessary treatment, patients with UCA ≥ 95° presented with a higher risk of sPTB compared to patients with UCA < 95°. This suggests that the UCA seems to be a better predictor of sPTB than the cervical length in patients receiving pessary treatment.

A Multidisciplinary Approach for Treating Women with Pelvic Organ Prolapse in Pregnancy: A Series of Eight Women.

BACKGROUND: Pelvic organ prolapse in pregnancy is rare. Consequent complications include cervical infection, spontaneous abortion, and premature birth. Conservative management by means of a pessary have been described as improving maternal symptomatology and minimizing gestational risk. The delivery mode is controversial. OBJECTIVES: To describe the clinical courses of patients diagnosed with pelvic organ prolapse during pregnancy, and to present our multidisciplinary approach. METHODS: In this retrospective case series, we summarized the obstetrical outcomes of women diagnosed with pelvic organ prolapse during pregnancy in a single university-affiliated hospital. RESULTS: We identified eight women with advanced uterine prolapse at a mean age of 30.3 years. Seven were diagnosed with advanced uterine prolapse (Pelvic Organ Prolapse Quantification [POPQ] stage ≥ 3). All were treated by pessary placement, which was tolerable and provided symptomatic relief. The pessary type was chosen according to the prolapse stage. In women with cervical prolapse POPQ stage > 2 and cervical edema, a support pessary was less beneficial. However, the prolapse was well-controlled with a space-filling Gellhorn pessary. Low complication rates were associated with vaginal deliveries. The few complications that were reported included minor cervical laceration, postpartum hemorrhage, and retained placenta. CONCLUSIONS: Treatment of pelvic organ prolapse during pregnancy must be individualized and requires a multidisciplinary approach of urogynecologists, obstetricians, dietitians, pelvic floor physiotherapists, and social workers. Conservative management, consisting of insertion of a vaginal pessary when prolapse symptoms appeared, provided adequate support for the pelvic floor, improved symptomatology, and minimized pregnancy complications. Vaginal delivery was feasible for most of the women.