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Background: Prediction of pregnancies at risk of preterm birth (PTB) may allow targeted prevention strategies. Objectives: To assess quality of clinical practice guidelines (CPGs) and identify areas of agreement and contention in prediction and prevention of spontaneous PTB. Search Strategy: We searched for CPGs regarding PTB prediction and prevention in asymptomatic singleton pregnancies without language restriction in January 2024. Selection Criteria: CPGs included were published between July 2017 and December 2023 and contained statements intended to direct clinical practice. Data Collection and Analysis: CPG quality was assessed using the AGREE‐II tool. Recommendations were extracted and grouped under domains of prediction and prevention, in general populations and high‐risk groups. Main Results: We included 37 CPGs from 20 organizations; all were of moderate or high quality overall. There was consensus in prediction of PTB by identification of risk factors and cervical length screening in high‐risk pregnancies and prevention of PTB by universal screening and treatment for asymptomatic bacteriuria, screening and treatment for BV in high‐risk pregnancies, and use of preventative progesterone and cerclage. Areas of contention or limited consensus were the role of PTB clinics, universal cervical length measurement, biomarkers and cervical pessaries. Conclusions: This review identified strengths and limitations of current PTB CPGs, and areas for future research. Synopsis: International clinical guidelines agree on several interventions to predict and prevent preterm birth; these are overall of good quality. [ABSTRACT FROM AUTHOR]

Objective Methods Results Conclusion To systematically review and synthesise what is known about the effectiveness of non‐pharmaceutical conservative interventions for the management of urinary incontinence (UI) experienced by women during physical exercise.A systematic search was performed in the following databases in September 2023: the Medical Literature Analysis and Retrieval System Online (MEDLINE), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Excerpta Medica dataBASE (EMBASE), Scientific Electronic Library Online (SciELO), Latin American and Caribbean Health Sciences Literature (LILACS), and Physiotherapy Evidence Database (PEDro). Studies were deemed eligible if population consisted of females who reported symptoms of UI while participating in physical exercise, and the interventions involved any non‐pharmaceutical conservative treatment to manage symptoms during exercise. The primary outcome was severity of UI signs and symptoms. The protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO identifier: CRD42022379138).Of the 3429 abstracts screened, 19 studies were retained. Pelvic floor muscle training (PFMT) and intravaginal devices were the most commonly investigated modalities. Only two randomised controlled trials (RCTs), both among volleyball players, compared PFMT with no PFM exercise, showing a reduction in pad weight gain after the intervention in the experimental groups only. PFMT with and without biofeedback randomised among soldiers demonstrated a reduction in the frequency of urine leakage episodes in both groups, while supervised and unsupervised PFMT randomised among athletes from different sports showed pad weight gain reduction in the supervised group only. Seven single‐arm studies suggested that PFMT alone or combined with other modalities may reduce UI severity in active women based on questionnaires, bladder diaries, and self‐reported symptoms. A single‐arm and a crossover study found pessary use beneficial in reducing urine leakage based on questionnaires and pad weight gain, respectively. When comparing pessary, tampon, and no intervention, two repeated‐measures studies found tampons may reduce leakage more than pessaries in CrossFit exercisers and women performing aerobic exercises. A vaginal sponge also reduced pad weight gain during aerobic exercises. Other modalities (i.e., an intraurethral device, photobiomodulation, and combined therapies) were investigated using case series or single case studies. While all interventions showed some evidence of effectiveness, the results must be interpreted with caution due to methodological limitations and high risk of bias. In particular, despite a high reliance on pad tests as a primary outcome, we identified inconsistencies in how pad tests were administered and interpreted.Only the effectiveness of PFMT to reduce urine leakage during exercise has been evaluated through RCTs, with some evidence of effectiveness. We identified a clear need for higher quality studies, with better reporting on the interventions, and more judicious use and interpretation of outcome measures. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

The article provides modern literature data on terminology, diagnostics and new approaches to the treatment of short cervix syndrome. The term «short cervix» combines the concept of short cervix and isthmic-cervical insufficiency in most of the guiding documents of the world obstetrics and gynecology societies. However, the issues of diagnosis and correction of these conditions remain relevant and debatable: sonographic criteria, the use of progesterone, cerclage, obstetric pessaries, their various combinations, and the question of their effectiveness. It is necessary to measure the cervix length by transvaginal cervicometry in the 20 weeks of pregnancy in the absence of previous reproductive losses and in the period of 14–16 weeks if there were previous reproductive losses. Therapeutic interventions should be started (vaginal micronized progesterone, cerclage, obstetric pessary) when the cervix is shortened to 25 mm or less at 20 weeks. Urgent cerclage should be performed when the umbilical cord is shortened to 20 mm or less. The effectiveness of cerclage, according to most experts, is comparable to the effectiveness of vaginal progesterone, unlike obstetric pessaries, the effectiveness of which is currently considered unproven. For our country today, in addition to the generally recognized risk factors of this pathology, the factors associated with improper conditions for providing medical care and their consequences are especially relevant. Childbirth in inappropriate places without observing the rules of asepsis and antiseptics, often without qualified medical personnel, can lead to undiagnosed and lack of suturing of cervical tears), their infection, subsequent deformation and functional failure of the cervix. There is also a need to support the micronutrient status of pregnant women in wartime conditions in Ukraine (vitamins of group B, vitamin D, magnesium, polyunsaturated fatty acids) in combination with progestins (micronized progesterone Luteinа) and/or cerclage in case of short cervix. [ABSTRACT FROM AUTHOR]

ABSTRACT 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.

Abstract 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.

Women with symptomatic pelvic organ prolapse are offered a choice of conservative and surgical treatment options. Two thirds of women choose a vaginal pessary, a support device inserted in the vagina. This article reports the finding of a randomized controlled trial published in 2023 evaluating the cost-effectiveness of self-management of pessary compared to clinic-based care. Women were recruited in 21 centres across the UK and 340 women were randomized to pessary self-management or clinic-based care. The primary outcome measure was prolapse-specific quality of life and secondary outcomes were generic quality of life, pelvic floor symptoms, sexual function, self-efficacy, pessary complications, pessary use and pessary confidence. Participants' health care resource use was measured. The trial showed that at 18 month follow-up self-management was not associated with better or worse quality of life than clinic-based care. Women in the self-management group reported fewer pessary complications and lower healthcare resource use. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Pelvic health physiotherapy is recommended as first-line treatment for those with lower urinary tract symptoms and pelvic floor dysfunction. Pelvic health physiotherapists treat a number of genitourinary conditions conservatively, including stress urinary incontinence, overactive bladder, pelvic organ prolapse and vaginal atrophy. When physiotherapy management alone does not fully resolve symptoms, medication may be required. Independent prescribing enables the physiotherapist to maintain continuity of care, allowing a smoother, more effective patient journey. This offers quicker access to medicines and helps avoid delays in commencing appropriate treatment, reducing waiting times across other services. In this article, the role of the pelvic health physiotherapy independent prescriber is detailed in a case study of a patient referred with symptoms of stress urinary incontinence associated with impaired pelvic floor function and episodic constipation, in addition to perimenopausal vaginal dryness causing dyspareunia. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. Plain language summary 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. Scientific summary Background Pelvic organ prolapse (hereafter prolapse) is the descent of some, or all, of the female pelvic organs from their usual position in the pelvis into the vagina. Prolapse is a common problem, with studies suggesting that up to 65% of women may be affected. Prolapse incidence increases with age. As the population ages, prolapse presents a growing health problem. Women who experience prolapse report bothersome symptoms that negatively affect their quality of life and body image. Symptoms include a feeling of ‘something coming down’ into the vagina; urinary, bowel and sexual symptoms; and pain. Prolapse can be treated conservatively or surgically. Between 10% and 30% of women who have prolapse surgery may need repeat surgery, and the controversy around the use of surgical mesh has brought the focus onto conservative treatment options. One conservative treatment option is vaginal pessary. The pessary is an inexpensive mechanical device that is inserted into the vagina to support the pelvic organs. Pessaries are widely used in the NHS, with two-thirds of women initially choosing a vaginal pessary to treat their prolapse symptoms. The current UK care pathway for women who use a pessary as treatment for prolapse is that the pessary is usually fitted at a gynaecological clinic, or occasionally at a general practitioner surgery, and the woman returns approximately every 6 months to have it removed and replaced with a new one. However, having to return to clinic every 6 months may be inconvenient for women, having a pessary permanently in situ may interfere with sexual intercourse, and the patient may require a review in clinic before 6 months because the pessary has fallen out or because of pessary complications (e.g. vaginal discomfort). An alternative to clinic-based pessary care is pessary self-management, whereby a woman removes and reinserts the pessary herself at home, thus offering her more control over her ability to maintain and improve her own health. Research in other clinical domains suggests that self-management is beneficial because people improve their self-efficacy (confidence) in looking after their own health. To the best of our knowledge, there is no current evidence on the effectiveness of pessary self-management for women with prolapse. The treatment of prolapse with self-care pessary (TOPSY) study aims to fill that evidence gap. Objective The TOPSY trial aimed to evaluate the clinical effectiveness and cost-effectiveness of self-management of a vaginal pessary on the prolapse-specific quality of life of women with pelvic organ prolapse when compared with clinic-based care. Clinic-based care is the standard operating model for many pessary services across the UK. The process evaluation undertaken concurrently with the trial aimed to assess, using a mixed-methods design, intervention acceptability, pathways to effectiveness, adherence to treatment and fidelity. Methods We undertook a parallel-group, multicentre, randomised controlled trial, with individual randomisation, which assessed the superiority of self-management compared with clinic-based pessary care for women who used a pessary for prolapse. Allocation was carried out remotely via a web-based computer system, with minimisation by age (< 65/≥ 65 years), pessary user type (new user/existing user) and centre. A sample size of 330 women (165 per group) was required to provide 90% power to detect a difference of 20 points in the Pelvic Floor Impact Questionnaire-7 score (which measures prolapse-specific quality of life) at 18 months after randomisation, assuming a standard deviation of 50, two-sided alpha of 0.05 and 20% loss to follow-up. Participants were recruited from 21 UK centres where pessary care was routinely provided. Women who were new pessary users (had used a pessary for ≤ 3 months) and existing users (had used a pessary for > 3 months) were identified by centre staff and via patient notes, clinic lists, caseloads and referral letters. Potentially eligible women were sent an invitation letter or approached in clinic by centre staff. Women were eligible for inclusion if they were aged ≥ 18 years, were using a pessary of any material or type (except shelf, Gellhorn or cube pessaries) and had retained the pessary for at least 2 weeks. Women were excluded if they had limited manual dexterity that would affect their ability to remove and replace their pessary; were judged by their healthcare team to have a cognitive deficit such that it was not possible for them to provide informed consent or to self-manage; were pregnant; or had insufficient understanding of the English language (the self-management intervention was only available in English). The primary outcome of effectiveness was prolapse-specific quality of life, measured using the Pelvic Floor Impact Questionnaire-7, and of cost-effectiveness was incremental cost per quality-adjusted life-year at 18 months post randomisation. Interim follow-ups were undertaken at 6 and 12 months. Secondary outcome measures included generic quality of life [measured using the EuroQol-5 Dimensions, five-level (EQ-5D-5L)]; pelvic floor symptoms (measured using the Pelvic Floor Distress Inventory-20); sexual function (measured using the prolapse/incontinence sexual questionnaire-IUGA-Revised); self-efficacy (measured using the General Self-efficacy Scale); pessary complications; pessary use; and pessary confidence. Resource use data were collected using a specifically developed health Resource Use Questionnaire. Study centres received a training visit during which the principles of self-management were explained and the intervention delivery staff were trained in the components of the intervention. Each centre also received a training manual that provided written guidance on the intervention. Women randomised to self-management received: a 30-minute self-management teaching appointment where they were taught to, and given the opportunity to try to, remove, clean and reinsert their own pessary a self-management information leaflet that provided written and diagrammatic information on pessary self-management a 2-week follow-up telephone call to assess if they had been able to remove, clean and reinsert their pessary since the teaching appointment and to assess any difficulties they experienced a telephone helpline number for their local clinical centre. Women in the clinic-based care group received routine appointments at which their pessary was removed and cleaned, or changed for a new one, and replaced by a healthcare professional. The interval between the appointments was determined by the usual practice of the centre. A concurrent mixed-methods process evaluation was undertaken to assess intervention acceptability, pathways to effectiveness, adherence to treatment and fidelity. Recruiting staff at centres were asked to audio-record a sample of their recruitment discussions. Staff delivering the intervention were asked to record a sample of self-management teaching appointments and 2-week follow-up telephone calls and to complete a checklist for every self-management teaching session undertaken to allow assessment of fidelity to the intervention. A subsample of women who were randomised in the trial and consented to take part in an additional interview study were interviewed at baseline and 18 months. Eligible women who declined to be randomised but were willing to take part in an interview study were also interviewed at baseline and 18 months. The Pessary Use Questionnaire included an open question about women’s experiences of their trial group. The interviews and open questions aimed to assess acceptability, adherence and pathways to effectiveness. Finally, recruiting centre staff and healthcare professionals who delivered the intervention were invited to take part in an interview to increase understanding of pathways to effectiveness and fidelity. A within-trial economic evaluation was conducted to compare the costs and benefits, measured in quality-adjusted life-years, of self-management with clinic-based care over the 18 months post randomisation. In addition, a decision-analytic model was developed using the trial data to extend the analysis over a 5-year period. Healthcare resource use data were collected from the clinic visit and telephone support case report forms and from the participant-completed Resource Use Questionnaire. Costs were attached to resource use from published sources. Health state utility values were elicited from responses to the EQ-5D-5L to estimate the difference in quality-adjusted life-years between the trial groups. The trial analysis followed the intention to treat principle, and the analyses of all study elements were documented in prespecified analysis plans. The qualitative analysis for the process evaluation followed framework analysis methods and, where appropriate, case study analytic methods. Results Key results: trial Three hundred and forty women were randomised: 169 to the self-management group and 171 to the clinic-based care group. At 18 months post randomisation, 291 questionnaires with valid primary outcome data were available: 139 (82.2%) in the self-management group and 152 (88.9%) in the clinic-based care group. There was no evidence of a difference between the groups in prolapse-specific quality of life (measured using the Pelvic Floor Impact Questionnaire-7) at 18 months (adjusted mean difference −0.03, 95% confidence interval −9.32 to 9.25). Sensitivity analysis of the primary outcome showed no significant difference between the groups under a range of different assumptions and prespecified sensitivity analyses. A subgroup analysis of the primary outcome showed no significant effect of trial group by subgroup interactions (subgroups were age < 65 vs. ≥ 65 years, new vs. existing pessary user and hysterectomy vs. no hysterectomy at baseline). At the 18-month follow-up, a greater proportion of pessary complications were reported in the clinic-based care group than in the self-management group (adjusted mean difference 3.83, 95% confidence interval 0.81 to 6.86). There was no difference between the groups in general self-efficacy, but women in the self-management group were more confident in their ability to manage pessary-related problems and to insert and remove their pessary. An analysis adjusting for clinic-based care appointments cancelled due to the COVID-19 pandemic did not alter the findings. Key results: process evaluation Self-management was reported to be an acceptable intervention to women and to healthcare professionals. Women (whether they received self-management or not) and healthcare professionals reported benefits from pessary self-management to women and the NHS and valued the possibilities provided to women who could self-manage their pessary, such as flexibility and independence in using the pessary as needed. There was fidelity to self-management intervention delivery and there was minimal variance in the delivery of clinic-based care across the study centres. Self-management delivery can be integrated within existing service structures. Interview data demonstrated that women’s adherence to their allocated group ranged from not adherent at all to completely adherent in all aspects, and this was the case in both groups. The COVID-19 pandemic did have an impact on adherence, especially among those in the clinic-based care group when clinic appointments were suspended, which led some women to remove their own pessary. Although the pandemic might have had some effect on adherence, multiple other contextual factors influenced adherence, such as good general health, which influenced it in both groups. Multiple contextual factors impacted on pathways to effectiveness for both trial groups. There was variance in women’s quality of life in both groups across the 18 months’ follow-up. The pessary itself influenced women’s quality of life, regardless of trial group. There was at least the potential for self-management to further enhance that quality of life over and above the influence of the pessary itself. Women in the self-management group had different self-efficacy from those in the clinic-based group. Women in the self-management group felt more confident in addressing common problems with their pessary, such as discharge or slippage, on their own without the need for additional clinic appointments. Key results: economic evaluation The within-trial economic analysis indicated that clinic-based care was dominated by self-management. There was no significant difference in the mean number of quality-adjusted life-years gained between self-management and clinic-based care (0.021), but the mean cost was lower for self-management than for clinic-based care (£578 vs. £728). The incremental net benefit estimated at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year gained was £564, with an 80.8% probability of cost-effectiveness. The modelling results are consistent with the trial analysis. The incremental net benefit at 5 years was estimated as £4221 and the probability that self-management is a cost-effective intervention was estimated as 69.7%. Key results: synthesis There was no evidence that self-management improved prolapse-specific or general quality of life more than clinic-based care. Although qualitative findings suggested that quality of life had the potential to be improved more in the self-management group, this did not translate beyond participant-level data. The proposed mechanism of action for the intervention was self-efficacy. General self-efficacy did not differ between the groups at 18 months. Women who self-managed were more confident in their abilities to insert and remove their pessary and to manage problems experienced with their pessary than women in the clinic-based care group. There was fidelity to the self-management and clinic-based care intervention delivery, with the groups receiving different interventions, confirming that the trial was a true test. There was variance in adherence to trial group by the women; approximately 40% of the clinic-based care group removed the pessary themselves at least once at some point during follow-up, and 34 women in the self-management group crossed over to clinic-based care. Women in the self-management group reported fewer complications than women in the clinic-based care group. Experience of complications led to a greater likelihood of women discontinuing pessary use. Conclusions Implications for health care Healthcare professionals and policy-makers can be confident that in offering self-management as an option to women who use a vaginal pessary to manage pelvic organ prolapse they are offering an acceptable intervention that will not make women’s quality of life better or worse than clinic-based care. Self-management will, however, reduce the pessary-related complications that women experience and will cost the NHS less to deliver than standard clinic-based care models. Self-management of vaginal pessaries should be offered as part of NHS services from the outset of pessary care and as part of routine, ongoing care. In offering self-management to women, healthcare professionals should explain the lower complication rates experienced by women who self-manage and the possible mechanisms that may lead to that reduction (such as women’s confidence in removing the pessary when experiencing discomfort). Healthcare professionals who deliver self-management training may wish to add further information about options for pessary removal into that training, as women found pessary removal more difficult than pessary insertion. Recommendations for research (in priority order) Future research is needed to identify constructs that are important to women in measuring their prolapse-specific quality of life. This may necessitate the generation of a new measure that has greater sensitivity to quality-of-life constructs beyond the symptomatic changes linked to the pessary itself. Future trials of self-management should test the effectiveness of self-management with a wide range of ethnic groups and with women of different abilities to assess its effectiveness in these populations. This may include the testing of devices that support pessary removal or insertion. Future research is needed that focuses on self-management follow-up. For example, can follow-up be women-initiated, or does it need to be planned at specific intervals? Future research on pessary self-management is needed to look at possible links between pessary continuation and complications, including which specific complications are more likely to lead to discontinuation. 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.

Objective: The aim of our study is to systematically review the literature about available devices facilitating perineal support during defecation in patients with obstructive defecation syndrome (ODS) and posterior pelvic organ prolapse (POP). Methods: We searched for the terms "defecat/ion or ODS" and" pessar/ies or device/aid/tool/perineal/perianal/prolapse and support" in MEDLINE, PubMed and Web of Science. Data abstraction was performed according to PRISMA (Preferred Reporting Items for Systematic reviews and Meta-analysis) guidelines. A two-stage inclusion was performed, selecting first on title and abstract and secondly the full text. For variables with sufficient data, a meta-analysis was performed using a random-effects model. Other variables were descriptively reported. Results: Ten studies out of 1332 were included for systematic review. The devices could be categorized into three groups: pessaries (n = 8), vaginal stent (n = 1) and external support device (n = 1). Methodology and data reporting is heterogeneous. Meta-analysis could be performed for the Colorectal-Anal Distress Inventory (CRADI-8) and Impact Questionnaire (CRAI-Q-7) in three pessary studies which showed a significant mean change. Significant improvement of stool evacuation was seen in two other pessary studies. The vaginal stent significantly decreases ODS. Subjective perception of constipation improved significantly using the posterior perineal support device. Conclusion: All reviewed devices seem to improve ODS in patients with POP. There are no data on their efficacy with regard to perineal descent-associated ODS. There is a lack of comparative studies between devices. Studies are difficult to compare due to different inclusion criteria and evaluation tools. [ABSTRACT FROM AUTHOR]

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Copyright of Die Gynäkologie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Catamenial products like menstrual tampons for managing menses and vaginal pessaries for managing urinary incontinence and uterine prolapse are products that can be inserted and removed from the vagina repeatedly over a woman's lifetime. In the United States (US), these products are considered to be medical devices and are regulated by the Center for Devices & Radiological Health (CDRH) of the Food and Drug Administration (FDA). As such, they are subject to both premarket and postmarket regulatory controls. Both tampons and pessaries have a long history of safe and effective use, and FDA applies a risk-based approach to both premarket entry as well as continued postmarket regulatory controls. Practicing clinicians are often the initial source of ideas for medical device improvements. This article is intended to help such clinicians to understand the regulatory challenges faced by development teams who seek to introduce these kinds of products to the US market. It explains FDA's risk-based classification of medical devices and the 510(k) premarket notification as the primary regulatory mechanism for market entry. It also highlights key FDA guidance documents and encourages early engagement with FDA when appropriate. [ABSTRACT FROM AUTHOR]

Ethylene vinyl acetate (EVA) with a vinyl acetate (VA) content of 28 wt.% (EVA28) is frequently used in vaginal inserts and subcutaneous implants due to its biocompatibility and drug‐releasing properties. Traditionally being processed via hot melt extrusion, its processibility via filament‐based 3D‐printing was reported to be impossible. Consequently, no applicable customization concepts for vaginal inserts exist. For the first time, the fabrication of 3D‐printed vaginal inserts (urethra pessaries) of EVA28 is demonstrated by optimizing its viscosity, employing 3D‐printer adaptations, and carefully selecting printing parameters. The infill pattern of fully filled mono‐material pessaries (determining the number and orientation of weld lines) significantly affects the in vitro release of the model drug progesterone (P4), while other critical parameters (the pessary's mechanical properties and appearance) remain unaffected. Weld lines act as diffusion barriers for dissolved P4 molecules. Hence, a high number of weld lines to be crossed reduces the overall P4 diffusivity in EVA28, decreasing the P4 release rate. To further control the P4 release, innovative multi‐material pessary designs (additionally comprising EVA with a VA content of 9 wt.% that is also used in vaginal inserts) allow to tailor the in vitro drug release and the mechanics individually. Thereby, this work highly improves the mechanistic understanding on drug release modifications from 3D‐printed non‐biodegradable devices. The findings build the basis for the first application of customized vaginal inserts, as they are based on polymers used in corresponding marketed products for more than 20 years. [ABSTRACT FROM AUTHOR]

Introduction and hypothesis: The objective was to compare the location and motion of pessaries between women with pelvic organ prolapse (POP) with a successful (fitting) and unsuccessful (non-fitting) pessary treatment on dynamic magnetic resonance imaging (dMRI). Methods: A cross-sectional exploratory study of 15 women who underwent a mid-sagittal dMRI of the pelvic floor at rest, during contraction and during Valsalva with three different types of pessaries. The coordinates of the pessaries cross section, inferior pubic point (IPP) and sacrococcygeal junction (SCJ) were obtained and the location (position, orientation) and the motion (translation and rotation) were calculated. Differences between the groups and between the pessaries within the groups were compared. Results: Nine women with a fitting pessary and 6 women with a non-fitting pessary were selected. In the non-fitting group, the pessaries were positioned more caudally and rotated more in clockwise direction and descended more, but not significantly, during Valsalva compared with the fitting group. The Falk pessary was positioned more anteriorly in the fitting group and more cranially in the non-fitting group compared with the ring and ring with support pessary. Conclusions: A non-fitting pessary was positioned more caudally at rest; on Valsalva, it rotated more clockwise and moved more caudally, suggesting that the dynamic characteristics of the pessary might play an important role in its effectiveness. Findings of this study serve as a basis for the development of new pessary designs. [ABSTRACT FROM AUTHOR]

Preterm birth is a major global health problem. Every year about 15 million babies are born prematurely in the world, of which 1 million newborns die. Spontaneous preterm birth (SPB) accounts for 40–45% of all preterm births. Cervical insufficiency (CI) is a significant risk factor for SPB. The studies have established the influence of the vaginal microbiome on cervical length during pregnancy and the importance of the bacterial composition of the vagina as a factor determining the risk of preterm birth. The objective: to study the vaginal microbiome of pregnant women with CI and various treatment methods (progesterone therapy, cervical suture or obstetric pessary). Materials and methods. During 2020–2023, an observational longitudinal study was conducted in the municipal non-profit enterprise “Perinatal Center of Kyiv”, in which 94 pregnant women participated. Among them 64 women were diagnosed CI (progesterone therapy group – n=22, cervical suture group – n=23 and obstetric pessary group – n=19). The control group included 30 pregnant women without CI. Results. Vaginal progesterone therapy and the use of a cervical suture have less effect on the microbiome than the use of a pessary. Conditionally pathogenic and pathogenic microflora was detected in 27.27% of patients in the progesterone group, 47.82% of patients in the cervical suture group, and 57.89% – in the pessary group. Inflammatory smear grade 3–4 was found in 31.81% of patients in the progesterone group, 47.82% – the cervical suture group, and 57.89% – the pessary group; complaints of discomfort and discharge – in 22.72%, 39.13% and 57.89% of patients, respectively. Compared with the control group, the use of a pessary is associated with an increase in the frequency of identification of opportunistic pathogenic microflora (16.67% vs. 52.63%; p<0.05), unsatisfactory results of bacterioscopic examination (20.00% vs. 57.89%; p<0.05), as well as an increase in complaints of discomfort and significant vaginal discharge (16.67% vs. 57.89%; p<0.05). Conclusions. It has been established that regardless of the type of therapy, inflammatory changes (presence of opportunistic pathogenic and pathogenic microflora, inflammatory type of smear, complaints of discharge and discomfort) of the birth canal are observed in pregnant women with CI. There is a connection between different methods of treatment and unsatisfactory results: bacteriological analysis – the presence of opportunistic pathogenic and pathogenic microflora (p<0.05), bacterioscopic analysis – inflammatory type of smear of the 3-4 grade of purity (p<0.05) and anamnestic analysis – the presence of complaints in female patients (p<0.05). [ABSTRACT FROM AUTHOR]

Set in the early twentieth century, this article maps the parallel histories of two popular contraceptive pessaries: 'Wife's Friend' in Britain and 'Lady's Friend' in China. Despite their limited efficacy, both products became commercially successful in their respective markets. Drawing on news articles and opinion columns, this article investigates how these two similar products were marketed to different demographics and adapted to meet the needs of local consumers, highlighting the ways in which medicines take on new meanings in different social and historical contexts. At the same time, the case of 'Wife's Friend' and 'Lady's Friend' pessaries also exposes the blurriness between the categories of Western and Traditional Chinese Medicine and the shortcomings of both types of medicine in the early twentieth century. Ultimately, this research shows that interrogating medicine from a comparative transnational perspective can yield new insights into the relationship between commercialisation, modernity and perceptions of health. [ABSTRACT FROM AUTHOR]

Background: Forty percent of women will experience prolapse in their lifetime. Vaginal pessaries are considered the first line of treatment in selected patients. Major complications of vaginal pessaries rarely occur. Methods: PubMed and Embase were searched from 1961 to 2022 for major complications of vaginal pessaries using Medical Subject Headings (MeSH) and free-text terms. The keywords were pessary or pessaries and: vaginal discharge, incontinence, entrapment, urinary infections, fistula, complications, and vaginal infection. The exclusion criteria were other languages than English, pregnancy, complications without a prior history of pessary placement, pessaries unregistered for clinical practice (herbal pessaries), or male patients. The extracted data included symptoms, findings upon examination, infection, type of complication, extragenital symptoms, and treatment. Results: We identified 1874 abstracts and full text articles; 54 were assessed for eligibility and 49 met the inclusion criteria. These 49 studies included data from 66 patients with pessary complications amenable to surgical correction. Clavien–Dindo classification was used to grade the complications. Most patients presented with vaginal symptoms such as bleeding, discharge, or ulceration. The most frequent complications were pessary incarceration and fistulas. Surgical treatment included removal of the pessary under local or general anesthesia, fistula repair, hysterectomy and vaginal repair, and the management of bleeding. Conclusions: Pessaries are a reasonable and durable treatment for pelvic organ prolapse. Complications are rare. Routine follow-ups are necessary. The ideal patient candidate must be able to remove and reintroduce their pessary on a regular basis; if not, this must be performed by a healthcare worker at regular intervals. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Purpose: This clinical study sought to evaluate the possible clinical effectiveness and practicality of URINO, an innovative, incisionless, and disposable intravaginal device, designed for patients suffering from stress urinary incontinence. Methods: A prospective, multicenter, single-arm clinical trial was carried out, involving women diagnosed with stress urinary incontinence who used a self-inserted, disposable intravaginal pessary device. Comparisons were made between the results of the 20-minute pad-weight gain (PWG) test at baseline and visit 3, where the device was applied. After 1 week of device usage, compliance, satisfaction, the sensation of a foreign body, and adverse events were assessed. Results: Out of 45 participants, 39 completed the trial and expressed satisfaction within the modified intention-to-treat group. The average 20-minute PWG of participants was 17.2±33.6 g at baseline and significantly dropped to 5.3±16.2 g at visit 3 with device application. A total of 87.2% of participants exhibited a reduction ratio of PWG by 50% or more, surpassing the clinical trial success benchmark of 76%. The mean compliance was recorded as 76.6%±26.6%, the average visual analogue scale score for patient satisfaction was 6.4±2.6, and the sensation of a foreign body, measured on a 5-point Likert scale, was 3.1±1.2 after 1 week of device use. No serious adverse events were reported; there was 1 instance of microscopic hematuria and 2 cases of pyuria, all of which recovered. Conclusions: The investigated device demonstrated significant clinical effectiveness and safety for patients with stress urinary incontinence. It was easy to use, showing favorable patient compliance. We propose that these disposable intravaginal pessaries could potentially be an alternative treatment for patients with stress urinary incontinence who are seeking nonsurgical options or are unable to undergo surgery. [ABSTRACT FROM AUTHOR]

This study extends observations on the effects of intra-vaginal progesterone treatment on the relationships between the time of luteolysis, emergence of the ovulatory follicle, timing of estrus and ewe fertility. Observations were made in progesterone - treated ewes in autumn, the spring equinox and late spring (Experiment 1, Data set 1) and in progesterone – treated ewes and naturally cycling ewes in autumn and the spring equinox (Experiment 1, Data set 2). In Data set 1, the day of emergence of both the first and second ovulatory follicle was positively related to the day luteal regression within each season. In turn, the day of emergence influenced the timing of estrus by means of a season by day of luteal regression interaction (P < 0.001) indicating that the relationship was positive in autumn and the spring equinox but negative in late spring. In autumn, older ovulatory follicles were associated with an earlier onset of estrus compared with younger ovulatory follicles. In late spring, this relationship was reversed and was influenced by whether or not ewes were cycling at the time of pessary insertion. In Data set 2, the relationship between the day of follicle emergence and luteal regression was influenced by a treatment by day of regression interaction indicating the relationship was positive in treated ewes and negative in naturally cycling ewes. Timing of estrus was positively related (P < 0.001) to both the day of luteal regression and the day of follicle emergence (P < 0.05), with both relationships being stronger in naturally cycling ewes than in treated ewes. In Experiment 2, pregnancy rate following artificial insemination in autumn was highest (90.2%) when luteolysis occurred during Days 7–9 of the pessary period compared with Days 1–6 (77.8%, P = 0.16), 10 to 12 (68.8%, P < 0.05) or Days ≥13 (71.2%, P < 0.05). Timing of estrus was not affected. The mean diameter of ovulatory follicles that emerged during Days 7–9 was larger on Day 12 (5.8 ± 0.13 mm) compared with other periods (range 4.7 ± 0.05 to 5.6 ± 0.14 mm). This study provides two potential strategies to improve the success of AI programs. Firstly, appropriately timed treatment with PGF2α to control the time of emergence of ovulatory follicles and, secondly, earlier treatment with eCG to improve the development of ovulatory follicles that emerge late in the pessary period. Each is likely to be influenced by season and the cyclical status of the ewe. • Timing of luteolysis and emergence of ovulatory follicles are associated. • Age of the ovulatory follicle influences timing of estrus. • These effects are influenced by season. • Time of luteolysis during pessary treatment influences pregnancy rate. • Two new strategies for synchrony of estrus are suggested. [ABSTRACT FROM AUTHOR]

Background: The therapeutic significance of the cervical pessary has been confirmed by several studies. However, the underlying mechanism by which pessaries reduce the risk of a preterm birth remains elusive. The aim of this study is to investigate the hypothesis whether the application of a cervical pessary may stabilize the ectocervical stiffness in order to achieve a cervical arrest. Methods: This is a prospective, controlled, non-interventional, post-market, monocentric, longitudinal, cohort study in a tertiary maternity hospital to determine ectocervical stiffness and its changes measured before and after placement of a pessary in singleton pregnancies with cervical shortening in the mid trimester. In order to assess reference values for cervical stiffness, we measured also singleton pregnancies with normal cervical length in the same gestational week spectrum. The cervical stiffness measured with the Pregnolia System as the Cervical Stiffness Index (CSI, in mbar) shall be the primary endpoint, whilst patient delivery data (gestational age, mode of delivery and complications) will be the secondary endpoint. In this pilot study, up to 142 subjects will be enrolled to have a total of 120 subjects (estimated dropout rate of 15%) to complete the study; pessary cohort: 60 (up to 71 recruited), control group: 60 (up to 71 recruited). Discussion: Our hypothesis is that patients with cervical shortening will present with lower CSI values and that pessary placement will be able to stabilize the CSI values through further prevention of cervical remodelling. The measurement of controls with normal cervical length shall serve as a reference. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Aims: To evaluate the effect of vaginal bleeding on the efficacy of controlled‐release dinoprostone delivery system (PROPESS) for cervical ripening and the factors affecting the PROPESS efficacy in a Japanese clinical setting. Methods: A total of 100 term pregnant women in whom PROPESS was used due to an unfavorable cervix (Bishop score ≤ 6) were enrolled. We retrospectively investigated which factors, including vaginal bleeding, were associated with the success of cervical ripening using logistic regression analysis. Moreover, the effect of vaginal bleeding on vaginal acidity was examined in 24 selected cases (control, 11; rupture of membrane, 4; and vaginal bleeding, 8). Results: A 25 women successfully ripened the cervix (effective group), and 75 were unsuccessful (noneffective group). Bishop score at insertion (adjusted odds ratio: 1.87; 95% confidence interval: 1.23–2.86; p = 0.004), and vaginal bleeding at PROPESS insertion (adjusted odds ratio 6.63; 95% confidence interval 1.21–36.36; p = 0.029) affected cervical ripening success. The cases with vaginal bleeding showed a significantly higher vaginal pH than the control cases (median value: 6.75 and 5.0, respectively). We identified no obvious adverse outcomes, such as tachysystole, fetal heart rate abnormality, or low Apgar/pH, associated with vaginal bleeding at insertion. Conclusions: Our findings suggest that the PROPESS efficacy depends on Bishop score at insertion and that vaginal bleeding at PROPESS insertion might have a significantly positive effect on cervical ripening in term pregnant women. [ABSTRACT FROM AUTHOR]

Introduction and hypothesis: Vaginal pessaries are used as a conservative treatment for POP in women who do not want or are not candidates for surgery, or as a preliminary step to surgery. Our goals are: evaluate the evolution of patients with advanced POP and repeated expulsion of the pessary, who underwent perineal suture to try to maintain the device. Describe the epidemiological characteristics of patients treated with pessaries in our environment, with or without perineal closure. Methods: Observational, descriptive and prospective study (October 2016-March 2021) that includes 352 women with advanced-stage POP treated with a pessary, of which 55, after repeated expulsion of the pessary, were treated with a pessary and perineal suture. Results: After pessary insertion associated with perineal closure, 26 patients (47.2%) expelled the pessary and underwent surgery, and 29 (52.8%) kept the device, avoiding surgery. Regarding the women who required perineal suture: The mean age was higher than in the group of patients who did not need this intervention (75.3 vs. 68.3 years), 94.5% had POP ≥ grade III and 100% had a perineal width > 2.5 cm. Conclusions: Treatment with pessary and perineal closure avoids surgery in women with advanced age and repeated expulsion. Although age should not be an independent factor that limits surgical treatment or the type of intervention, it would be useful to have scales to quantify the frailty of patients, being able to standardize perineal closure in elderly and/or frail women, and in those who do not want or have contraindications for surgery. [ABSTRACT FROM AUTHOR]

Pelvic organ prolapse (POP) is a common condition and is thought to affect approximately 40% of women over the age of 40, with prevalence increasing with age. Although POP is not usually associated with mortality, it can significantly impact quality of life. Management of POP includes, the option of no treatment, conservative and lifestyle management, pessary management or surgery. Options for management should take into consideration the woman's preference, the site of prolapse, lifestyle factors, comorbidities, age, desire for childbearing, previous surgery and whether the patient is sexually active. The risks and benefits of each option should be discussed, and women should be included in decision making. Vaginal pessaries are intravaginal devices that aim to restore prolapsed vaginal compartments to a normal position with aim to relieve symptoms. There are a wide variety of pessaries and these are usually made of plastic or silicone. The most commonly used pessaries in the UK are discussed in this article. [ABSTRACT FROM AUTHOR]

Progesterone treatment for synchrony of estrus is standard in sheep artificial insemination (AI) programs but can be associated with poor outcomes. Potential for improvement exists through a better understanding of the interactions between follicle development, luteal regression, emergence of the ovulatory follicle and timing of estrus. These interactions were examined by comparing progesterone-treated (Day 1 = day of pessary insertion) and naturally cycling ewes (Day 1 = day after estrus) at three times of the year (Autumn, Spring equinox and late Spring). Observations were made from Day 1 until the day of ovulation. Compared with the natural cycle, progesterone treatment (300 mg intra-vaginal pessary for 14 d) reduced the number of follicle waves (2.2 ± 0.18 versus 2.8 ± 0.12; P < 0.05) and increased the length of the ovulatory wave (8.6 ± 0.45 versus 6.6 ± 0.42 d; P < 0.05). The number of follicles per wave, the inter-wave interval and ovulation rate were not affected. However, progesterone treatment induced (P < 0.05) an earlier luteolysis (9.7 ± 0.51 versus 15.4 ± 0.49 d after Day 1), an earlier emergence of the ovulatory follicle (7.5 ± 0.48 versus 11.4 ± 0.46 d after Day 1) and an earlier onset of estrus (26.1 ± 2.95 versus 53.3 ± 2.84 h after Day 14). Time of year also influenced the response to progesterone treatment. In Autumn compared with the Spring equinox and late Spring, there was a reduction (P < 0.05) in follicle wave number (2.4 ± 0.21 versus 2.5 ± 0.29 versus 3.0 ± 0.20 respectively), follicles per wave (2.6 ± 0.27 versus 3.5 ± 0.25 versus 3.2 ± 0.20 respectively), ovulation rate (1.6 ± 0.12 versus 1.9 ± 0.12 versus 2.0 ± 0.10 respectively) and the inter-wave interval was longer (5.3 ± 0.40 versus 4.0 ± 0.32 versus 3.8 ± 0.27 d respectively; P < 0.05). Time of year also influenced (P < 0.05) the time of luteolysis (earliest in late Spring), emergence of the ovulatory follicle (earliest in Autumn) and onset of estrus (earliest in Autumn). It is concluded that (1) the effects of progesterone treatment on follicle waves are relatively minor, (2) the effects of treatment on timing of luteolysis, emergence of the ovulatory follicle and onset of estrus are all significant although the effects on AI outcomes remain to be determined and (3) time of year has a minimal effect on follicle waves but a more significant effect on other parameters of the estrous cycle. A better understanding of these complexities will assist in the development of improved protocols for synchrony of estrus. • Progesterone treatment reduced the number but increased length of follicle waves. • These effects are unlikely to influence synchrony of estrus or AI outcomes. • Season influenced follicle waves with potential to affect estrus and AI outcomes. • Treatment and season influenced luteolysis, ovulatory follicle emergence and estrus. [ABSTRACT FROM AUTHOR]

Women were individually interviewed using narrative inquiry and a semi-structured interview guide to explore their experiences using vaginal pessaries. Women shared personal experiences that demonstrated emotional aspects of using a vaginal pessary and the need for health care professionals to support women's decisions to use a pessary. [ABSTRACT FROM AUTHOR]

Background: Cervical pessary placement as an intervention for preterm birth prevention in women with a short cervix is a simple, painless procedure with few complications and a reasonable cost. Its efficacy depends on the expertise of the obstetrician performing the procedure. Therefore, it is reasonable to assume that untrained obstetricians with no expertise in pessary placement are more likely to insert the pessary incorrectly, thereby reducing its efficacy. Nevertheless, the impact of pessary placement expertise and training, as well as the accuracy of cervival length measurements, has never been evaluated.Objective: To evaluate the impact of providing training for pessary placement to obstetricians with no expertise in this intervention. To this end, the percentage of correct pessary placements and accuracy of cervical length measurements after pessary placement achieved by obstetricians who received such training was compared with the results achieved by obstetricians who did not receive any training.Methods: This prospective, double-blind, randomized clinical trial included 91 pregnant women requiring a cervical pessary due to a short cervix. Patients were assigned at random to a group treated by untrained obstetricians with no expertise in pessary placement (untrained group, n = 45) or to a group treated by trained obstetricians with no expertise in pessary placement (trained group, n = 46). The primary outcomes were the quality of pessary placement and the accuracy of cervical length measurements after pessary placement.Results: Obstetricians in the trained group achieved a significantly higher percentage of correct pessary placements than obstetricians in the untrained group (97.8 % and 65.2 %, respectively; p < 0.001). No significant differences were observed between groups in terms of the accuracy of cervical length measurements after pessary placement (p = 0.661), and both groups showed moderate to good agreement with the expert's measurements (intraclass correlation coefficient 0.840 and 0.749, respectively). No differences in pregnancy outcomes were observed between groups.Conclusion: This study showed that providing training in pessary placement to obstetricians with no expertise in this procedure increases the quality of pessary placement. Furthermore, the inconsistent results found in pessary studies may be explained, in part, by a lack of training in pessary placement. [ABSTRACT FROM AUTHOR]

Resumen: Introducción: El prolapso de órganos pélvicos (POP) presenta una incidencia general de >10% en la población femenina del mundo occidental. El pesario es un dispositivo que se introduce en la vagina para proveer soporte a los órganos pélvicos. Se utiliza como tratamiento conservador para mejorar los síntomas del prolapso. Objetivos: Evaluar las micciones entre las mujeres con pesario y las mujeres sin pesario. Evaluar la calidad de vida de las mujeres con POP cuando utilizan el pesario. Material y métodos: Estudio transversal, descriptivo, prospectivo y comparativo, de carácter analítico. Consistirá en analizar los resultados de tratamiento mediante pesarios vaginales en mujeres con POP. Un total de 60 mujeres fueron elegidas como muestra del estudio, al 50% se les colocó el pesario. Se utilizó el test de impresión global de mejoría del paciente (PGI por sus siglas en inglés) y la uroflujometría. Resultados: Las mujeres que utilizaron el pesario mejoran su dinámica miccional conforme van avanzando los meses, encontrándose diferencias significativas a partir de los 3 meses. Existe una correlación estadísticamente significativa entre la calidad de vida de las mujeres y la dinámica miccional. Conclusiones: El tratamiento conservador con el uso de pesario en anillo durante seis meses en mujeres con POP presentó mejoras significativas en los dominios de calidad de vida y dinámicas miccionales. Existe correlación entre la mejora de la calidad de vida y la mejora de las dinámicas miccionales de las mujeres con POP en tratamiento con pesario. Abstract: Introduction: Pelvic organ prolapse (POP) has a general incidence of > 10% in the female population of the Western world. A pessary is a device that is inserted into the vagina to provide support for the pelvic organs. It is used as a conservative treatment to improve prolapse symptoms. Objectives: To evaluate urination among women with pessary and women without pessary. Assess the quality of life of women with POP when using a pessary. Materials and methods: Cross-sectional, descriptive, prospective and comparative study, of an analytical nature. It will consist of analyzing the results of treatment with vaginal pessaries in women with POP. A total of 60 women were chosen as the study sample, 50% were assigned a pessary. The Patient Global Impression (PGI) scale and flujometry were used to assess results. Results: Women who used pessary improved their urination dynamics as the months went by, significant differences are found from 3 months. There is a statistically significant correlation between women's quality of life and mictional dynamics. Conclusions: Conservative treatment with the use of a ring pessary for six months in women with POP presented significant improvements in the domains of quality of life and mictional dynamics. Correlation exists between the improvement of the quality of life and the improvement of urinary dynamics of women with POP in pessary treatment.

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. [Display omitted] • Finite element models could improve understanding of how pessaries respond to load. • Material models of pessary manufacturing silicone are required for modeling. • Material and mechanical tests are used to generate and calibrate material models. • The identified models demonstrate accurate prediction of pessary response. • These models could be used to expedite pessary iteration and improvement. [ABSTRACT FROM AUTHOR]

Investigations were carried out in a commercial farm from Beba Veche, western Romania, on a number of 80 yearling ewes of 17-18 months of age from the native Tsigai. First group (V1), numbering 40 ewes received during out of season breeding (30.05.2011) a dose of 18 mg subcutaneous melatonin implants (Melovin®), while the second group (V2) consisting out of 40 ewes were treated with subcutaneous melatonin implants + 30 mg FGA (Syncro-Part pessaries) + 500 IU PMSG. Control group was represented by 40 intact females. Ewes were put to ram in 7th of July 2011. Researches shown that in ewes treated with melatonin, 30 mg FGA + 500 IU PMSG (V2) the conception rate was of 82.1%, with a prolificacy of 150%, and a weaning rate of 1.2 lamb/ewe. In V1 group, the weaning rate was of 0.9 lambs/ treated ewe, with significantly lower production costs. Ewes from the control group produced a lamb crop of 0.42 lambs/ewe, significantly less (p≤0.05) comparing to V1 and V2 experimental groups. It was concluded that in Tsigai breed, although the V2 group performed better (producing 48 lambs) compared to V1 group (36 lambs), the difference of 12 lambs does cover additional production costs, therefore the use of melatonin implants alone should be recommended.

Objective To identify the factors associated with unsuccessful pessary fitting and reasons for pessary discontinuation in Korean women with pelvic organ prolapse (POP). Methods The medical records of 234 patients who underwent pessary fitting for the management of symptomatic POP were retrospectively reviewed. A ring pessary with or without support was used. Successful pessary fitting was defined as the ability to wear a pessary for 2 weeks without any discomfort. Factors associated with unsuccessful pessary fitting were determined using a multivariable logistic regression analysis. A Kaplan-Meier survival curve was obtained to examine the probability of continuing pessary use over the follow-up period. The reasons for the discontinuation of pessary were identified. Results Two-hundred-and-twenty-five women were included in the analysis. The rate of unsuccessful pessary fitting was 40%. Prior hysterectomy (odds ratio [OR], 4.13; 95% confidence interval [CI], 1.81–9.42) and POP quantification stage III–IV (OR, 2.49; 95% CI, 1.28–4.85) were independent risk factors for unsuccessful pessary fitting. Among the patients with successful pessary fitting, the median time to discontinuation of pessary use was 4 years. The most common causes of discontinued use were vaginal erosion (45.3%) and urinary incontinence (26.5%). Conclusion Patients with a history of hysterectomy and advanced-stage POP are at risk for an unsuccessful fitting of the ring pessary. Vaginal erosion is the main reason for discontinued use among patients with successful pessary fitting.

Vaginal pessaries are commonly used for uterine prolapse. Long forgotten pessaries get incarcerated in the vagina and may erode in the bladder and rectum. We present a unique case of a 60-year-old female patient who presented with dysuria and urge incontinence. In remote areas, bangles are still used as a pessary, which may present with atypical symptoms due to bladder perforation, encrustation, and Vesicovaginal fistula (VVF). VVF with a long curved tract can heal with prolonged catheterization. To our knowledge, this is the first case of glass bangle pessary being reported. [ABSTRACT FROM AUTHOR]

Over the past 50 years, pessary use has increased in popularity and has become an essential pelvic organ prolapse (POP) management tool. However, evidence is lacking to define care standardization, including pessary fitting, routine maintenance, and management of pessary-related complications. This clinical consensus statement (CCS) on vaginal pessary use and management for POP reflects statements drafted by content experts from the American Urogynecologic Society and Society of Urologic Nurses and Associates. The purpose of this CCS is to identify areas of expert consensus and non-consensus regarding pessary fitting, follow-up, and management of pessary complications to improve the safety and quality of care where evidence is currently limited. The American Urogynecologic Society and Society of Urologic Nurses and Associates' vaginal pessary for POP writing group used a modified Delphi process to assess statements that were evaluated for consensus after a structured literature search. A total of 31 statements were assessed and divided into 3 categories: (1) fitting and follow-up, (2) complications, and 3) quality of life. Of the 31 statements that were assessed, all statements reached consensus after 2 rounds of the Delphi survey. This CCS document hopefully serves as a first step toward standardization of pessary care, but the writing group acknowledges that improved research will grow the base of knowledge and evidence providing clinicians a foundation to manage pessary care effectively and confidently. [ABSTRACT FROM AUTHOR]

Collagen is the predominant structural protein within connective tissues. Pelvic organ prolapse (POP) is characterized by weakening of the pelvic floor connective tissues and loss of support for pelvic organs. In this study, we examined the multiscale structure, molecular composition and biomechanics of native collagen fibrils in connective tissues of the posterior vaginal fornix collected from healthy women and POP patients, and established the correlation of these properties with clinical POP quantification (POP-Q) scores. The collagen characteristics, including collagen amount, ratio of Collagen I and Collagen III, collagen fibril d -period, alignment and stiffness, were found to change progressively with the increase of the clinical measurement of Point C, a measure of uterine descent and apical prolapse. The results imply that a severe prolapse is associated with stiffer collagen fibrils, reduced collagen d -period, increased fibril alignment and imbalanced collagen synthesis, degradation and deposition. Additionally, prolapse progression appears to be synchronized with deterioration of the collagen matrix, suggesting that a POP-Q score obtained via a non-invasive clinical test can be potentially used to quantitatively assess collagen abnormality of a patient's local tissue. Abnormal collagen metabolism and deposition are known to associate with connective tissue disorders, such as pelvic organ prolapse. Quantitative correlation of the biochemical and biophysical characteristics of collagen in a prolapse patient's tissue with the clinical diagnostic measurements is unexplored and unestablished. This study fills the knowledge gap between clinical prolapse quantification and the individual's cellular and molecular disorders leading to connective tissue failure, thus, provides the basis for clinicians to employ personalized treatment that can best manage the patient's condition and to alert pre-symptomatic patients for early management to avoid unwanted surgery. [Display omitted] [ABSTRACT FROM AUTHOR]

To evaluate neonatal outcomes after the use of a cervical pessary in Japanese women with short cervical length (CL) less than 25 mm. This multicenter study involved women with singleton pregnancies between 20 and 29+6 gestational weeks and a CL of less than 25 mm. The primary outcome was preterm birth (PTB) before 34 weeks of gestation. This study was registered in the Japan Registry of Clinical Trials (JRCT: jRCTs042180102). Two hundred pregnant women were enrolled; 114 in the pessary group and 86 in the expectant management group as controls. In the pessary group, all 114 neonates were investigated for perinatal outcomes, and 112 pregnant women were investigated for primary, and secondary outcomes. In the control group, 86 pregnant women were investigated for primary and secondary outcomes and 86 neonates were investigated for neonatal outcomes. There were no significant differences in PTB in ≤34, ≤37, and ≤28 weeks of gestation or in preterm rupture of membranes (PROM) ≤34 weeks between the groups. The gestational weeks at birth and birth weight were significantly higher in the pessary group. Regression analysis demonstrated that the CL decreased without a pessary, whereas the shortening rate was suppressed during the intervention. No significant differences were observed in adverse neonatal outcomes, chorioamnionitis, or preterm PROM. The cervical pessary effectively reduced CL shortening during pregnancy resulting in an average increased gestational age, however, did not reduced the rates of preterm birth. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the existing evidence on the efficacy of pessaries in improving quality of life when used for the treatment of pelvic organ prolapse (POP).Data Sources: We searched for the terms "pelvic organ prolapse" and "pessar/y/ies/ium or vaginal support device," and "safety or safe or outcome or complication or efficacy or effective or effectiveness" in PubMed, EMBASE, and CINAHL on March 16, 2020. A search was also performed on ClinicalTrials.gov , with no studies fitting our strict inclusion and exclusion criteria.Methods Of Study Selection: Studies that reported pretreatment and posttreatment mean scores and SDs after pessary treatment for standardized questionnaires were included. Studies performed in pediatric populations, pregnancy, and use of pessaries not for prolapse were excluded. Three reviewers independently screened studies.Tabulation, Integration, and Results: Data abstraction was performed according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Data were pooled for meta-analysis when reported by at least three studies. The primary study outcome was change in mean pretreatment and posttreatment questionnaire scores, which included those for the PFDI-20 (Pelvic Floor Distress Inventory- Short Form 20), PFIQ-7 (Pelvic Floor Impact Questionnaire - Short Form 7), and subscale POPIQ (Pelvic Organ Prolapse Impact Questionnaire Long Form). A random-effects model was used to combine estimates and capture between-study heterogeneity using the I 2 -statistic. Eight studies including 627 patients were included for systematic review. The mean (SD) age was 63.0±12.2 years, and the majority of patients had stage III prolapse (48.1%) followed by stage II prolapse (43.2%) when reported. Although variable, the majority of studies conducted 3-month follow-up. A negative change in pretreatment and posttreatment scores was noted, signifying improvement after pessary use: PFDI-20 mean change -46.1 (95% CI -65.4 to -26.8); PFIQ-7 mean change -36.0 (95% CI -46.0 to -26.0); POPIQ-7 (Pelvic Organ Prolapse Impact Questionnaire-7) mean change -16.3 (95% CI -26.8 to -5.7). No significant heterogeneity was found.Conclusion: Based on improvements in standardized questionnaire scores, pessaries are effective treatment options for POP.Systematic Review Registration: PROSPERO, CRD42020172618. [ABSTRACT FROM AUTHOR]

The aim. to study the therapeutic influence of new pessaries Melanizol based on metronidazole and tea tree oil on the background of model of "chemical" vaginitis in female rats. Materials and methods. The therapeutic effect of pessaries Melanizol was studied in female rats on the model of "chemical" vaginitis with using argentum nitrate, which provokes vaginitis not burdened by infection. Against the background of vaginitis, the general condition of animals, the dynamics of body weight, the morphological composition of peripheral blood and the erythrocyte sedimentation rate (ESR), pH, biochemical parameters (total protein, ALT and glucose), temperature in the vagina of rats, macroscopically assessed changes in the vaginal mucosa (VM) were studied. Results and discussion. Against the background of pathology in the animals, a shift in the studied indicators was observed. Pessaries Melanizol at the dose of 21 mg/kg make a therapeutic effect on the model of experimental "chemical" vaginitis, caused by argentum nitrate, as indicated by the restoration of the VM state, reduced the number of leukocytes, restored the percentage composition of the leukocyte formula, reduced the amount of total protein and the cytolytic enzyme ALT in blood serum and vaginal contents, which indicates the anti-inflammatory and cytoprotective effect of the studied agent. The recovery of vaginal temperature, pH and the amount of glucose in the vaginal contents was also observed, which indicates the normalization of homeostasis in the vagina of experimental animals. According to these effects, the studied pessaries Melanizol were superior to the reference drug "Gravagin" at the dose of 30 mg/kg and were not inferior to the reference drug Hippophaes oleum pessaries (HOP) at the dose of 17.64 mg/kg. Conclusions. The therapeutic effect of new pessaries Melanizol based on metronidazole and tea tree oil on the model of "chemical" vaginitis in female rats has been proven. The investigated pessaries Melanizol are a promising drug for the treatment of non-specific vaginitis and require further research in this direction [ABSTRACT FROM AUTHOR]

Background: Pelvic organ prolapse (POP) is a common condition in women, where the downward descent of pelvic organs into the vagina causes symptoms which impacts quality of life. Vaginal pessaries offer an effective alternative to surgery for the management of POP. However, the need for regular follow-up can be burdensome for women and requires significant healthcare resources. The TOPSY study is a randomised controlled trial which aims to determine the clinical and cost-effectiveness of self-management of vaginal pessaries. This paper describes the theoretical and practical development of the self-management intervention.Methods: The intervention was developed using the MRC complex intervention framework, normalisation process theory (NPT) and self-management theory. The intervention aims to boost perceived self-efficacy in accordance with Bandura's social cognitive theory and is guided by the tasks and skills Lorig and Hollman describe as necessary to self-manage a health condition.Results: The TOPSY intervention was designed to support women to undertake the medical management, role management and emotional management of their pessary. The six self-management skills described by Lorig and Hollman: problem-solving, decision-making, resource utilisation, formation of a patient-provider partnership role, action planning and self-tailoring, are discussed in detail, including how women were supported to achieve each task within the context of pessary self-management. The TOPSY intervention includes a self-management support session with a pessary practitioner trained in intervention delivery, a follow-up phone call 2 weeks later and ongoing telephone or face-to-face support as required by the woman initiated by contacting a member of the research team.Conclusions: The TOPSY study intervention was developed utilising the findings from a prior service development project, intervention development and self-efficacy theory, relevant literature, clinician experience and feedback from pessary using women and members of the public. In 2022, the findings of the TOPSY study will provide further evidence to inform this important aspect of pessary management.Trial Registration: ISRCTN Registry ISRCTN62510577 . Registered on June 10, 2017. [ABSTRACT FROM AUTHOR]

Objectives: The ability to predict spontaneous PTB (sPTB) has improved greatly, allowing women at risk to be managed with prophylactic interventions such as cervical cerclage and the Arabin pessary. Cervicovaginal fetal fibronectin (qfFN) concentration and ultrasound measurement of cervical length (CL) are the two most established tools to predict sPTB. There is however limited data regarding the predictive value of qfFN and CL tests following insertion of an Arabin pessary. Our aim was therefore to determine the clinical use of qfFN and CL measurements to predict sPTB in women fitted with an Arabin pessary.Study Design: This study is a secondary analysis on the SUPPORT trial data. Data were prospectively collected from women attending high-risk preterm surveillance clinics in 3 London centres between July 2015 and April 2020. The matched control group was pregnant women attending the same high-risk preterm surveillance clinics who had not received an Arabin pessary. Receiver operating characteristic (ROC) curves for prediction of birth by 34 and by 37 weeks' gestation were generated for qfFN and CL measurements combined for both study groups. A formal comparison of area under the curve before 34 weeks' gestation (AUC < 34 weeks) was made between the two study groups.Results: At our primary endpoint of sPTB < 34 weeks' gestation, qfFN was a good predictor of sPTB in cases with an Arabin pessary in situ (AUC, 0.79, 95% CI: 0.62-0.90) and no worse than the control group who did not have an Arabin pessary, (AUC 0.74, 95% CI: 0.48-0.96). CL had good prediction for sPTB < 34 weeks' gestation in the control group (AUC 0.76, 95% CI: 0.63-0.88) but was lower and non-significant in the Arabin pessary case group (AUC 0.60, 95% CI: 0.43-0.76).Conclusions: This study showed that cervicovaginal qfFN concentration is equally reliable in the prediction of sPTB in pregnant women at increased risk of sPTB with and without an Arabin pessary in situ, and significantly better than CL measurement alone for predicting delivery before 34 weeks. This commonly used test therefore has utility in predicting sPTB in pregnant women fitted with an Arabin pessary. [ABSTRACT FROM AUTHOR]