A new screening of preterm birth in gestation with short cervix after pessary plus progesterone.

Objective: This study aims to create a new screening for preterm birth < 34 weeks after gestation with a cervical length (CL) ≤ 30 mm, based on clinical, demographic, and sonographic characteristics. Methods: This is a post hoc analysis of a randomized clinical trial (RCT), which included pregnancies, in middle-gestation, screened with transvaginal ultrasound. After observing inclusion criteria, the patient was invited to compare pessary plus progesterone (PP) versus progesterone only (P) (1:1). The objective was to determine which variables were associated with severe preterm birth using logistic regression (LR). The area under the curve (AUC), sensitivity, specificity, and positive predictive value (PPV) and negative predictive value (NPV) were calculated for both groups after applying LR, with a false positive rate (FPR) set at 10%. Results: The RCT included 936 patients, 475 in PP and 461 in P. The LR selected: ethnics white, absence of previous curettage, previous preterm birth, singleton gestation, precocious identification of short cervix, CL < 14.7 mm, CL in curve > 21.0 mm. The AUC (CI95%), sensitivity, specificity, PPV, and PNV, with 10% of FPR, were respectively 0.978 (0.961-0.995), 83.4%, 98.1%, 83.4% and 98.1% for PP < 34 weeks; and 0.765 (0.665-0.864), 38.7%, 92.1%, 26.1% and 95.4%, for P < 28 weeks. Conclusion: Logistic regression can be effective to screen preterm birth < 34 weeks in patients in the PP Group and all pregnancies with CL ≤ 30 mm.

Educational video for adherence to vaginal pessary in pelvic organ prolapse treatment.

OBJECTIVES: to construct and assess an educational video to promote the adherence of women with pelvic organ prolapse to vaginal pessary use. METHODS: this is a methodological study, with a longitudinal design and quantitative analysis. The pre-production (synopsis, argument, script, storyboard), production and post-production stages were covered. Content and technical assessments were carried out by judges from the health and communication areas, respectively, and appearance assessment by the target audience. RESULTS: the video was the first to be developed on the topic on the national scene, considered assessed from the point of view of appearance and content, presenting an overall Content Validity Index of 0.99 and a level of agreement among judges of 91.1% to 100%. Assessment by the target audience reached a percentage of 96% to 100%. CONCLUSIONS: the educational video is an instrument capable of promoting adherence to pessary in women indicated for this therapeutic approach.

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.

Incarcerated Uterine Prolapse: A Result of Neglect.

An 80-year-old lady was brought with the three-month history of irreducible prolapse with infected ulcer at anterior vaginal wall. She initially attempted home remedies for infection with locally available materials. On examination she was ill looking, febrile with stage IV prolapse according to pelvic organ prolapse quantification classification. She was treated initially with antiseptic wash, followed by local estrogen therapy and glycerine. Prolapse was repositioned when edema decreased and held in place with silicon ring pessary with definitive management planned for later date.

Exploring Clinicians' Willingness to Embrace Customizable Pessaries: A Survey Study in the USA.

INTRODUCTION AND HYPOTHESIS: This study surveyed urogynecologists and Advanced Practice Providers (APPs) in the USA to gauge their interest and willingness to embrace customizable pessaries as a viable treatment option. We hypothesize that clinicians might be interested in using customizable pessaries in their practice. METHODS: A cross-sectional survey was conducted among urogynecologists and their APPs who fit pessaries to gain insights into their experiences with standard pessaries and perspectives on the value and feasibility of customizable devices. The survey was distributed through email lists associated with women's health and pelvic floor disorders and gathered data on the difficulty in fitting pessaries and the perceived advantages of integrating customizable options into clinical practice. RESULTS: There were 122 participants, including 76 physicians and 46 APPs. Thirty-five percent of clinicians advocated for pessaries as a first-line therapy for pelvic floor disorders. APPs were more inclined to recommend pessaries as a primary therapy than physicians (p < 0.01). Fifty-three percent of providers reported occasional difficulties, and 12% reported frequent difficulties fitting patients with standard-shaped pessaries. APPs were significantly more likely to encounter fitting issues due to pessary shape (p = 0.023). Clinicians suggested additional practices, such as modifying pessaries to enhance retention in patients with an enlarged genital hiatus, shortened vaginas, or apical narrowing. CONCLUSIONS: This study indicates that clinicians are inclined to incorporate customizable pessaries into their treatment protocols for pelvic floor disorders, emphasizing the need for continued innovation in pessary customization that prioritizes a patient-centric approach to pelvic floor disorder management.

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.

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Objective: To study and compare the clinical effects of cervical pessary and progesterone for preventing preterm birth in singleton pregnant women with a short cervical length (CL). Methods: This study was a prospective cohort study. A total of 148 pregnant women with CL≤25 mm, as determined by ultrasound examination performed before 28 weeks of pregnancy, were included in the study. All subjects were admitted to West China Second Hospital, Sichuan University between August 2020 and December 2022. According to their treatment plans, the pregnant women were divided into a cervical pessary group (n=55) and a progesterone group (n=93). Spontaneous preterm birth before 37 weeks of pregnancy was defined as the main outcome index. Preterm birth (abortion) or spontaneous preterm birth (abortion) before 37, 34, 32, 30, and 28 weeks of pregnancy, mean extended gestational age, neonatal morbidity, and neonatal mortality were the secondary outcome indicators. The pregnancy outcomes and the neonatal outcomes of the two groups were compared and statistically analyzed. Results: There was no statistically significant difference in the incidence of preterm birth (including iatrogenic preterm birth, spontaneous preterm birth, and abortion) before 37, 34, 32, 30, and 28 weeks between the cervical pessary group and the progesterone group. When iatrogenic preterm birth was excluded, the incidence of spontaneous preterm birth before 37 weeks was lower in the cervical pessary group (23.6%) than that in the progesterone group (41.9%), with the difference between the two groups being statistically significant (P=0.024). There was no statistically significant difference in the incidence of spontaneous preterm birth (including miscarriage) before 34, 32, 30, and 28 weeks. There was no statistically significant difference in the incidence of neonatal morbidity, the rate of transfer to the neonatal care unit after birth, and the neonatal mortality rate between the two groups. Multivariate logistic analysis showed that treatment with cervical pessary was a protective factor for spontaneous preterm birth before 37 weeks compared to progesterone therapy. Conclusion: Using cervical pessary to prevent spontaneous preterm birth in singleton pregnant women with a short cervical length in the second trimester can significantly reduce the incidence of spontaneous preterm birth before 37 weeks.

Hyperelastic material models for simulating deformation of silicone ring pessaries.

Pessaries are removable gynecological prosthetic devices that provide mechanical support for temporary or long-term symptom relief of pelvic floor disorders, such as pelvic organ prolapse and stress urinary incontinence. To date, limited mechanical tests have been performed on physical pessary designs to characterize their behaviour under load; however, custom pessary manufacturing is expensive and time consuming. As an alternative, finite element (FE) modeling can provide detailed numerical insight into the response of a pessary design under load but to date has seen limited application, with little data available for pessary silicone materials. This study aimed to identify hyperelastic material models for two silicone materials used in custom pessary cocoon moulded manufacturing towards FE analysis of ring with support (RWS) pessaries. It was hypothesized that hyperelastic material models could be identified to capture the force and deformation response of multiple RWS sizes under different boundary conditions and silicone materials (Shore 60A and 40A). To understand the material characteristics of pessary silicone, uniaxial tension and compression tests were performed then the experimental data was fit with Mooney-Rivlin (MR) material models. To ensure the material models characterize the pessary behaviour, data from mechanical tests representing the RWS pessary folding and modified 3-point bending were compared to FE recreations (FEBio) of the same tests with the MR materials applied to the pessaries. The FE model results demonstrated good agreement in the force-displacement response for the fold and 3-point bending models for different pessary sizes and silicone stiffnesses. This work demonstrates the hyperelastic material models' efficacy and will enable future studies to improve biomechanical analysis of silicone pessary designs.

Use of Myo-Inositol Vaginal Pessary in the Treatment of Subfertility.

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Risk of pelvic organ prolapse after hysterectomy for benign conditions: A nationwide cohort study.

OBJECTIVE: To assess the risk of pelvic organ prolapse (POP) after hysterectomy for benign conditions. STUDY DESIGN: This nationwide retrospective cohort study, utilizing data from the Korean National Health Insurance Service database, compared women aged 40 to 59 who underwent benign hysterectomy between 2002 and 2011 (hysterectomy group) with those who had national medical examinations during the same period (nonhysterectomy group). The analysis used a 1:1 propensity score matching method adjusted for variables. MAIN OUTCOME MEASURE: Incident POP. RESULTS: The final sample of 32,984 participants (16,492 in each group) had a median age of 47 years [45-50] (p-value 0.305) and a median follow-up of 11.4 years [10-13.3] (p-value 0.189). The incidence of POP was 0.5 % in the nonhysterectomy group and 0.6 % in the hysterectomy group. Hysterectomy was associated with an increased risk of POP that required surgery or pessary use (hazard ratio [HR] 1.403, 95 % confidence interval [CI] 1.026-1.919). Subtotal hysterectomy was not associated with an increased risk of POP (HR 1.868, 95 % CI, 0.624-5.593), while total hysterectomy was associated with an increased risk (HR 1.633, 95 % CI, 1.083-2.46). Laparoscopic surgery was not associated with an increased risk of POP (HR 0.611, 95 % CI 0.311-1.202). CONCLUSIONS: The study found that, overall, hysterectomy is linked to a higher risk of POP, but subtotal hysterectomy and laparoscopy are not associated with increased risk, while total hysterectomy is associated with a higher risk.

Research progress in female pelvic floor rehabilitation aids. / å¥³æ€§ç›†åº•åº·å¤è¾ åŠ©å™¨å ·çš„ç ”ç©¶è¿›å±•.

Pelvic floor dysfunction (PFD) is a common clinical problem that can lead to bladder and bowel dysfunction such as urinary incontinence, urinary retention, fecal incontinence, pelvic organ prolapse, and sexual dysfunction. Pelvic floor rehabilitation aids are essential tools in the treatment of PFD. However, there is limited understanding of the efficacy and mechanisms of these aids, and there is a lack of standardized guidelines for selecting appropriate aids for different types of PFD. To assist patients in choosing suitable pelvic floor rehabilitation aids to their needs, it is necessary to summarize the existing types, mechanisms, and applications of these aids. Based on their mechanisms and target functions, pelvic floor rehabilitation aids can be mainly categorized into 3 main types. The first type includes aids that improve pelvic floor function, such as vaginal dumbbells, vaginal tampons, and vaginal dilators, which aim to strengthen pelvic floor muscles and enhance the contractility of the urethral, vaginal, and anal sphincters, thereby improving incontinence symptoms. The second type consists of aids that mechanically block the outlet, such as pessaries, urethral plugs, incontinence pads, incontinence pants, anal plugs, and vaginal bowel control systems, which directly or indirectly prevent incontinence leakage. The third type includes aids that assist in outlet drainage, such as catheters and anal excreta collection devices, which help patients effectively expel urine, feces, and other waste materials, preventing incontinence leakage. By summarizing the existing pelvic floor rehabilitation aids, personalized guidance can be provided to patients with PFD, helping them select the appropriate aids for their rehabilitation needs.

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.

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.

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.

Value of pelvic examination in women with pelvic organ prolapse: A systematic review.

BACKGROUND: Recent recommendations from the French High Authority of Health on pelvic organ prolapse (POP) management underline the value of a pelvic examination. OBJECTIVES: The aim of this paper was to analyze the literature and identify the best evidence available regarding pelvic examination for women presenting prolapse-associated symptoms in terms of diagnosis and predictability of treatment success. SEARCH STRATEGY: The databases were queried similarly using Medical Subject Headings (MeSH) and non-MeSH terms broadly related to pelvic examination and POP management. SELECTION CRITERIA: We included studies assessing the diagnostic contribution of pelvic examination (correlation with symptoms) and its value for assessing the risk of pessary failure or recurrence after reconstructive surgery. DATA COLLECTION AND ANALYSIS: We assessed peer-reviewed articles on PubMed, Embase, and Cochrane database up to May 2023. The methodological quality of all the included studies was assessed using the ROBINS-E or RoB2 tools. MAIN RESULTS: In all, 67 studies were retained for the review. Prolapse-associated symptoms are poorly correlated with POP diagnosis. The symptom that is best correlated with the POP stage is the presence of a vaginal bulge (moderate to good correlation). The factors most strongly associated with the risk of recurrence after surgery or pessary failure are clinical: essentially a higher POP stage before surgery, levator ani muscle avulsion, and vaginal and genital measurements. CONCLUSIONS: In women complaining of prolapse-associated symptoms, a pelvic examination (vaginal speculum and digital vaginal examination) can confirm the presence of POP and identify risk factors for treatment failure or recurrence after surgical management or pessary placement. A higher stage of POP and levator ani muscle avulsion-discernible on pelvic examination-are major risk factors for POP recurrence or treatment failure. These features must be taken into account in the treatment choice and discussed with the patient.

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.

A multimodality review of gynecologic devices in the pelvis.

There are a wide variety of gynecologic devices encountered on pelvic imaging which may not be the focus or primary reason for imaging. Such devices include pessaries, menstrual products, radiation therapy devices, tubal occlusion devices, and contraceptive devices, including intrauterine devices and intravaginal rings. This manuscript offers a comprehensive review of multimodality imaging appearances of gynecologic devices encountered on pelvic imaging and discusses device indications, positioning, and complications.

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.

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).

Clinical and cost-effectiveness of pessary self-management versus clinic-based care for pelvic organ prolapse in women: the TOPSY RCT with process evaluation.

Background: Pelvic organ prolapse is common, causes unpleasant symptoms and negatively affects women's quality of life. In the UK, most women with pelvic organ prolapse attend clinics for pessary care. Objectives: To determine the clinical effectiveness and cost-effectiveness of vaginal pessary self-management on prolapse-specific quality of life for women with prolapse compared with clinic-based care; and to assess intervention acceptability and contextual influences on effectiveness, adherence and fidelity. Design: A multicentre, parallel-group, superiority randomised controlled trial with a mixed-methods process evaluation. Participants: Women attending UK NHS outpatient pessary services, aged ≥ 18 years, using a pessary of any type/material (except shelf, Gellhorn or Cube) for at least 2 weeks. Exclusions: women with limited manual dexterity, with cognitive deficit (prohibiting consent or self-management), pregnant or non-English-speaking. Intervention: The self-management intervention involved a 30-minute teaching appointment, an information leaflet, a 2-week follow-up telephone call and a local clinic telephone helpline number. Clinic-based care involved routine appointments determined by centres' usual practice. Allocation: Remote web-based application; minimisation was by age, pessary user type and centre. Blinding: Participants, those delivering the intervention and researchers were not blinded to group allocation. Outcomes: The patient-reported primary outcome (measured using the Pelvic Floor Impact Questionnaire-7) was prolapse-specific quality of life, and the cost-effectiveness outcome was incremental cost per quality-adjusted life-year (a specifically developed health Resource Use Questionnaire was used) at 18 months post randomisation. Secondary outcome measures included self-efficacy and complications. Process evaluation data were collected by interview, audio-recording and checklist. Analysis was by intention to treat. Results: Three hundred and forty women were randomised (self-management, n = 169; clinic-based care, n = 171). At 18 months post randomisation, 291 questionnaires with valid primary outcome data were available (self-management, n = 139; clinic-based care, n = 152). Baseline economic analysis was based on 264 participants (self-management, n = 125; clinic-based care, n = 139) with valid quality of life and resource use data. Self-management was an acceptable intervention. There was no group difference in prolapse-specific quality of life at 18 months (adjusted mean difference -0.03, 95% confidence interval -9.32 to 9.25). There was fidelity to intervention delivery. Self-management was cost-effective at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year gained, with an estimated incremental net benefit of £564.32 and an 80.81% probability of cost-effectiveness. At 18 months, more pessary complications were reported in the clinic-based care group (adjusted mean difference 3.83, 95% confidence interval 0.81 to 6.86). There was no group difference in general self-efficacy, but self-managing women were more confident in pessary self-management activities. In both groups, contextual factors impacted on adherence and effectiveness. There were no reported serious unexpected serious adverse reactions. There were 32 serious adverse events (self-management, n = 17; clinic-based care, n = 14), all unrelated to the intervention. Skew in the baseline data for the Pelvic Floor Impact Questionnaire-7, the influence of the global COVID-19 pandemic, the potential effects of crossover and the lack of ethnic diversity in the recruited sample were possible limitations. Conclusions: Self-management was acceptable and cost-effective, led to fewer complications and did not improve or worsen quality of life for women with prolapse compared with clinic-based care. Future research is needed to develop a quality-of-life measure that is sensitive to the changes women desire from treatment. Study registration: This study is registered as ISRCTN62510577. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/82/01) and is published in full in Health Technology Assessment; Vol. 28, No. 23. See the NIHR Funding and Awards website for further award information.

Pelvic organ prolapse is a common and distressing condition experienced by large numbers of women. Prolapse is when the organs that are usually in the pelvis drop down into the vagina. Women experience a feeling of something coming down into the vagina, along with bowel, bladder and sexual problems. One possible treatment is a vaginal pessary. The pessary is a device that is inserted into the vagina and holds the pelvic organs back in their usual place. Women who use a vaginal pessary usually come back to clinic every 6 months to have their pessary removed and replaced; this is called clinic-based care. However, it is possible for a woman to look after the pessary herself; this is called self-management. This study compared self-management with clinic-based care. Three hundred and forty women with prolapse took part; 171 received clinic-based care and 169 undertook self-management. Each woman had an equal chance of being in either group. Women in the self-management group received a 30-minute teaching appointment, an information leaflet, a 2-week follow-up telephone call and a telephone number for their local centre. Women in the clinic-based care group returned to clinic as advised by the treating healthcare professional. Self-management was found to be acceptable. Women self-managed their pessary in ways that suited their lifestyle. After 18 months, there was no difference between the groups in women's quality of life. Women in the self-management group experienced fewer pessary complications than women who received clinic-based care. Self-management costs less to deliver than clinic-based care. In summary, self-management did not improve women's quality of life more than clinic-based care, but it did lead to women experiencing fewer complications and cost less to deliver in the NHS. The findings support self-management as a treatment pathway for women using a pessary for prolapse.