Pessary Management Research Articles

LONG-TERM SELF-MANAGEMENT OF VAGINAL CUBE PESSARIES CAN IMPROVE SEXUAL LIFE IN PATIENTS WITH PELVIC ORGAN PROLAPSE

Pelvic organ prolapse (POP) is a widespread health issue that affects a significant proportion of women, particularly those who have experienced childbirth, undergone hysterectomy, or are postmenopausal. Objective: This study employs a secondary analysis to explore the long-term self-management of vaginal cube pessaries and its potential impact on sexual health in women with pelvic organ prolapse (POP). Methods: The retrospective observational study was conducted at Sandeman Provincial Hospital in Quetta from 01 August 2022 to 31 July 2023. The sample consists of 100 women diagnosed with pelvic organ prolapse who were treated with vaginal cube pessaries. Data was collected from the clinical records of patients who were part of the hospital’s pessary management program during the study period. Results: Data were collected from 100 participants. The majority of participants in this study were between the ages of 50 and 69 years (65%), with 75% of the women being postmenopausal. A significant portion of the population (60%) had more than two children, which is a common risk factor for pelvic organ prolapse. Most of the participants were diagnosed with moderate to severe prolapse, with 45% in Stage II and 30% in Stage III, indicating that the sample represents a range of prolapse severity, including advanced cases (Stage IV, 15%). Patient satisfaction with pessary self-management was generally high, with 50% of participants being highly satisfied and 30% moderately satisfied. Only 20% expressed dissatisfaction, which suggests that most women found self-managing their pessaries to be beneficial. Conclusion: This study concludes that long-term self-management of vaginal cube pessaries significantly improves sexual function and overall quality of life in women with pelvic organ prolapse.

Preventing the Next Neglected Pessary: A Quality Improvement Initiative.

Pessaries are commonly used to manage pelvic organ prolapse. Pessary management can be done by a medical professional or the patient themselves. Pessary complications are rare. However, pessaries can be difficult to track, and patients who are lost to follow-up are at an increased risk of complications such as vaginal ulceration, pessary embedment, and fistulization. To create and implement a quality improvement initiative focusing on preventing neglected pessaries. Through the electronic medical record, we implemented a quality improvement initiative focused on creating a workflow where a pessary can be designated as an implant when inserted. A year after implementation, data was gathered. We identified 37% (55/147) of patients without follow-up in the 3 months after pessary placement. Of those, 24% were no longer using pessaries, 24% were self-maintaining or having surveillance with their primary OB/GYN, 16% had surgery for pelvic organ prolapse since placement of the pessary, 15% were lost to follow-up and were considered to be patients "at risk," and 12% did not have a pessary placed to begin with. Review showed 53% of patients with proper documentation and designation of pessary as an implant. This quality improvement initiative can identify patients lost to follow-up, leading to improved patient care and potential to prevent complications.

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

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

Pessary management for pelvic organ prolapse: a review of clinical practice and Australian medical device regulations

Pessary management for pelvic organ prolapse: a review of clinical practice and Australian medical device regulations

Pessary management practices for pelvic organ prolapse among Australian health care practitioners: a cross-sectional study.

Vaginal pessaries are a low-cost, effective treatment for pelvic organ prolapse (POP) and an alternative to surgery. Whilst traditionally pessary management (PM) has been provided by medical professionals, particularly gynaecologists, recent international studies found other professionals, including physiotherapists and nurses, may be involved. It is unknown which health care practitioners (HCPs) provide PM for POP in Australia or the distribution of services. In a cross-sectional study design, a self-reported electronic survey investigated Australian HCPs providing PM for POP. Purposive and snowball sampling targeted HCPs, professional organisations and health care facilities. Descriptive statistics described PM in relation to HCP professional profile, PM provision and geographical location. There were 536 respondents (324 physiotherapists, 148 specialists, 33 general practitioners (GPs) and 31 nurses providing PM. Most worked within metropolitan regions (n=332, 64%), 140 (27%) in rural, 108 (21%) in regional and 10 (2%) in remote areas. Most worked privately (n=418, 85%), 153 (46%) worked publicly and 85 (17%) in both. Ring pessaries were most commonly used, followed by cube and Gellhorn. HCPs reported variable training in PM, and 336 (69%) had no mandatory workplace competency standard; however, 324 (67%) wanted further training. Women travelled long distances to access services. Doctors, nurses and physiotherapists provided PM in Australia. HCPs had variable training and experience in PM, with rural and remote HCPs particularly wanting further training. This study highlights the need for accessible PM services, standardised and competency-based training for HCPs, and governance structures ensuring safe care.

Pessary Management Approach Affects Likelihood of Surgery.

It is unknown whether the pessary management type influences the need for surgery. The aim of this study was to evaluate the rate of surgical treatment for pelvic organ prolapse or stress urinary incontinence with the type of pessary management (self-management or office management). We conducted a retrospective cohort study that included first-time pessary users treated at a tertiary urogynecologic clinic from 2012 to 2014 for pelvic organ prolapse, stress urinary incontinence, or both. For the primary outcome, we explored the relationship between pessary management type and the likelihood of surgery using multivariable Cox proportional hazards models. Secondary outcomes assessed relationships between patient factors (eg, demographics and clinical attributes) and pessary management type using multivariable logistics regression models. There were 218 patients included in our analysis. Of all pessary users, 59 (27.1%) required office management and 159 (72.9%) participated in self-management. Surgery was performed in 22 (35.1%) office-managed patients and 33 (19.3%) self-managed patients. Women who self-managed their pessaries were significantly less likely to undergo surgery than those who received office management (multivariable hazards ratios, 0.416; P = 0.005). In the multivariable logistic regression model for pessary management type, increasing age (odds ratio [OR], 1.098; P ≤ 0.0001), increasing body mass index (OR, 1.078; P < 0.05), and increasing genital hiatus (OR, 1.547; P < 0.05) were associated with increased odds of pessary office management compared with self-management. In a urogynecology clinic setting, pessary self-management is associated with lower rates of surgical treatment compared with office management. Factors associated with office management include increased age, body mass index, and large genital hiatus.

Sacrospinous Ligament Fixation Using an Anchor Versus Suture-Capturing Device: A Prospective Cohort Study.

The aim of the study was to compare rates of persistent gluteal and posterior thigh pain, procedural efficacy, and postoperative complications at 1 year after sacrospinous ligament fixation using either an anchor-based or suture-capturing device. This prospective cohort study evaluated outcomes 1 year after operation in patients previously enrolled in a randomized controlled trial comparing an anchor-based versus suture-capturing device for sacrospinous fixation. Symptom scores were evaluated via Pelvic Floor Distress Inventory 20 and Pelvic Floor Impact Questionnaire 7. Pain was evaluated using the Numerical Rating Scale. Composite surgical failure was defined as prolapse beyond the hymen or C-point greater than one half down the vagina, vaginal bulge symptoms, or a need for prolapse retreatment via surgery or pessary management. Descriptive and bivariate statistics were performed. Forty three (21 anchors, 22 sutures) of the original 47 patients (91%) returned for follow-up. The mean follow-up time was 15.4 months, age was 69 years old, body mass index was 30, and preoperative Pelvic Organ Prolapse Quantification stage was 2.7. No patients reported significant increase in pain at sacrospinous fixation site above baseline, and there was no significant difference in posterior thigh or gluteal pain on the side of fixation compared with baseline in the anchor-based or suture-capture groups (-0.2 ± 0.9 and -0.5 ± 1.6, respectively, P = 0.719). Two patients demonstrated surgical failure (anchor group) due to bulge symptoms (P = 0.233). The devices similarly improved Pelvic Floor Distress Inventory 20 (-71.0 ± 45.5 vs -66.3 ± 64.4, P = 0.652) and Pelvic Floor Impact Questionnaire 7 (-40.6 ± 62.4 vs -26.4 ± 65.7, P = 0.768) scores. Persistent gluteal or posterior thigh pain and surgical failure is uncommon 12 months after sacrospinous fixation and was not associated with the type of fixation device.

What is known from the existing literature about self-management of pessaries for pelvic organ prolapse? A scoping review protocol

IntroductionPelvic organ prolapse (POP) can be managed with a pessary; however, regular follow-up may deter women from pessary management due to the inconvenience of frequent appointments, as well as preventing...

Do patients discharged from the physiotherapy-led pelvic health clinic re-present to the urogynaecology service?

The physiotherapy-led pelvic health clinic (PLPHC) is an advanced practice clinic that manages women from the urogynaecology waitlist with pelvic organ prolapse (POP) and/or urinary incontinence (UI) at Gold Coast Health, Australia. This study was aimed at determining re-referral rates and reasons for re-presentation of women previously managed and discharged from the PLPHC. We hypothesised that there would be low representation rates for the same condition within 12months of discharge. A retrospective audit was undertaken of all (n = 209) patients discharged between 1 January and 31 December 2017. Re-presentation rates and reasons for re-referral for women seen in the PLPHC and discharged without requiring urogynaecology medical specialist review were analysed and descriptive analysis performed. Of the 209 patients, 67 were referred to, or had, urogynaecology medical specialist review after their initial physiotherapy care and were removed from further analysis. Of the remaining 142 patients, who were initially managed by physiotherapy only, 10 (7.1%) women were re-referred to specialist medical outpatient gynaecology and urology out-patient departments, for management of a different diagnosis, and 10 (7.1%) for their original diagnoses, within 12months of discharge. Of the latter, 1 patient required further physiotherapy and urogynaecologist management; 7 patients required ongoing pessary management; 1 patient continued with urologist medical management; and 1 failed to attend. This study presents novel data on low re-presentation rates in the 12months following discharge for patients with POP or UI managed in a PLPHC; and provides further support for advanced scope of practice physiotherapy gynaecological service models.

Pessaries and rectovaginal fistulae: consequences of delayed clinical follow-up in the Covid-19 pandemic.

Introduction and hypothesisWhile 2017 guidelines from The American College of Obstetricians & Gynecologists called for pessary replacement every 3 to 4 months, a recent study in Obstetrics and Gynecology suggested that uninterrupted pessary use up to 6 months is not an independent risk factor for development of pessary-related complications.MethodsOur recent experience throughout the Covid-19 pandemic highlights the potential ramifications of delayed clinical follow-up.ResultsDuring the Covid-19 pandemic, 3 of our patients developed rectovaginal fistulae secondary to Gellhorn pessary erosion in the context of delayed clinical follow-up. Our patients had previously attended routine appointments every 3 months without complications until missed appointments secondary to the pandemic led to fistulae formation.ConclusionWe believe that delayed clinical follow-up of pessary management beyond 3 months due to the Covid-19 pandemic may lead to fistula complications in elderly women with Gellhorn pessaries.

Development of a multinational, multidisciplinary competency framework for physiotherapy training in pessary management: an E-Delphi study.

Vaginal support pessaries are intravaginal devices designed to relieve symptoms of pelvic organ prolapse, but they can cause serious medical complications if not managed well. Physiotherapists are well placed to manage pessaries, but there are no guidelines on the training required for competency in pessary management (PM). A scoping review of current literature on PM training was conducted to develop draft competency standards, which were reviewed by a multidisciplinary focus group. Using e-Delphi methodology, a multidisciplinary and multinational expert panel then refined the standards. Three rounds of e-Delphi online surveys were conducted, with individual participant feedback and one videoconference to discuss items that did not reach consensus. Consensus was set at 80% agreement and stability measured using kappa coefficient. Pessary training competency standards, developed by 29 experts, covered three key domains including: (1) prerequisite knowledge and understanding; (2) entrustable professional activities; (3) pessary-specific standards under ten key roles. Consensus was reached on all 73 (100%) competency standards and stability demonstrated for 95.9% of standards. There was no attrition of expert panel participants through the e-Delphi rounds. This e-Delphi study provides the first, robust recommendations on training standards for physiotherapists in PM. These competency standards will provide clinicians with a self-assessment tool, and educators and training institutions with a benchmark in training for PM, which should improve options and reduce risk for women with prolapse being managed with a pessary.

Pessary Management for the General Gynecologist

Pessaries are vaginal support devices that come in a variety of shapes and sizes. The purpose of this book chapter is to describe the indications, management, outcomes, and complications associated with pessaries for the general practitioner. A review of the pessary is provided. Information is based on primary literature, systematic reviews, and current expert opinion. Pessaries are most commonly used for pelvic organ prolapse and stress urinary incontinence. They are easy to place and have minimal serious side effects. The majority of women can be successfully fitted with a pessary in the outpatient setting. Pessaries improve vaginal bulge symptoms, urinary complaints, body image, and quality of life for women with pelvic floor disorders. Therefore, pessaries are safe and effective options for the management of pelvic floor disorders and should be offered to patients with pelvic organ prolapse and stress urinary incontinence. This review contains 5 tables, 6 figures and 30 references. Key Words: conservative management, Gellhorn pessary, pelvic organ prolapse (POP), ring pessary, SUI, urinary urgency, vaginal exam

Current trends in pessary management of vaginal prolapse: a multidisciplinary survey of UK practice.

Symptomatic vaginal prolapse affects 6-28% of women and significantly impacts their quality of life. Pessaries for prolapse are used by three-quarters of clinicians as a first-line treatment; however, current clinical use in the UK is unknown and there is a lack of clinical guidance or training. This study is aimed at informing the upcoming UK Clinical Guidance on best practice for the use of pessaries document. A 19-question, anonymised, electronic survey was sent to members of the nine professional bodies delivering pessary care in the UK. Of 917 respondents, 403 (246 nurses, 134 doctors, 22 physiotherapists and 1 other profession) currently deliver pessary care. PVC/vinyl ring, silicone ring, Gellhorn and shelf pessaries are most popular, and are used frequently by 93% of respondents. Further pessary training was deemed necessary by 62% of those currently providing pessary care, and 70% of those who do not. The most highly rated method for previous and future training is shadowing another clinician. One in three respondents receive no ancillary support and nearly 1 in 7 (predominantly nurses) report the absence of cross-cover arrangements, leaving a gap in care provision. Service provision, support and pessary training in the UK vary greatly. This calls for the standardisation of care, training and development of a national guideline. We present a clear rationale and need for a UK guideline on pessary management of vaginal prolapse and a standardised pessary training model for multi-professional use.

A service evaluation to determine where and who delivers pessary care in the UK.

Pessaries offer effective conservative management for symptoms of pelvic organ prolapse and are frequently used in the UK. Previous publications have highlighted a lack of evidence-based pessary guidelines. There is also a dearth of evidence regarding who UK pessary practitioners are and the training received. A Freedom of Information request was sent to 167 healthcare organisations in the UK. Requested information included the number of pessaries inserted or changed, the grade and profession of pessary practitioners and training requirements at the organisation. Responses were received from 128 organisations. One hundred and ten had provided information for practitioners managing pessaries. At 66% (72) of organisations, pessary care was provided by both doctors and nurses of varying grades. At 23% of organisations either solely doctors or solely nurses provided pessary care. At the remaining 9% there was a multidisciplinary approach to pessary care. At 3 hospitals, unregistered healthcare professionals provided pessary care. At the majority of organisations, respondents undertook supervised practise to gain skills in pessary management. Additional methods of training cited were learning through observation or achieving set competencies. Twenty-six percent received didactic training. At 21% of organisations there were no training requirements. At most organisations, there was a multidisciplinary approach to pessary care. It is questionable whether unregistered healthcare professionals should be delegated responsibility for pessary care. A standardised approach to pessary practitioner training is advocated to ensure that women receive safe, evidence-based pessary care. The UK Clinical Guidance Group for the Use of Pessaries in Vaginal Prolapse is currently developing national evidence-based guidelines to support pessary practitioners in their practice, including training requirements.

Validation of the Chinese version of the Pelvic Organ Prolapse Symptom Score (POP-SS).

The objective of the present study was to translate the Pelvic Organ Prolapse Symptom Score (POP-SS) into Chinese and validate it in a population of Chinese women. The POP-SS questionnaire was translated into simplified Chinese language following an intercultural adaptation procedure. One hundred forty-six patients who met the inclusion criteria were recruited. Among the enrolled patients, 63 underwent surgery for POP and 50 underwent pessary management. They completed the questionnaires at baseline (T1), 1 to 2 weeks later (T2), and 3 months after intervention (T3). Evaluation for psychometric properties was conducted following with the COnsensus-based Standards for the selection of health Measurement INstruments checklist, including internal consistency, test-retest reliability, measurement error, content validity, criterion validity, construct validity, responsiveness, and interpretability. The POP-SS was successfully translated into a Chinese version and achieved good content validity. Internal consistency (Cronbach's alpha = 0.796) was good, and test-retest reliability was excellent (intraclass correlation coefficients = 0.98; P < 0.001). The construct validity was verified by factor analysis and consistent with the theoretical structure of the original questionnaire. The POP-SS score was also significantly correlated with Pelvic Floor Distress Inventory-20 (Spearman's correlation coefficient = 0.89, P < 0.001). The confirmatory factor analysis identified two factors: physical symptoms and evacuation symptoms. The mean changes among the participants in very much better (9.80 ± 5.36) and much better (5.67 ± 2.99) groups were larger than those among the participants in the no change group (0.43 ± 2.07). The effect size responsiveness parameter in the much better group (>0.80) was larger than that in the no change group (<0.20). The values of the minimal important change for surgery and pessary groups were both larger than the smallest detectable change, indicating sufficient responsiveness. The Chinese version of POP-SS is a reliable and valid instrument and has good sensitivity to change in the population studied.

A guide for urogynecologic patient care utilizing telemedicine during the COVID-19 pandemic: review of existing evidence.

Introduction and hypothesisThe COVID-19 pandemic and the desire to “flatten the curve” of transmission have significantly affected the way providers care for patients. Female Pelvic Medicine and Reconstructive Surgeons (FPMRS) must provide high quality of care through remote access such as telemedicine. No clear guidelines exist on the use of telemedicine in FPMRS. Using expedited literature review methodology, we provide guidance regarding management of common outpatient urogynecology scenarios during the pandemic.MethodsWe grouped FPMRS conditions into those in which virtual management differs from direct in-person visits and conditions in which treatment would emphasize behavioral and conservative counseling but not deviate from current management paradigms. We conducted expedited literature review on four topics (telemedicine in FPMRS, pessary management, urinary tract infections, urinary retention) and addressed four other topics (urinary incontinence, prolapse, fecal incontinence, defecatory dysfunction) based on existing systematic reviews and guidelines. We further compiled expert consensus regarding management of FPMRS patients in the virtual setting, scenarios when in-person visits are necessary, symptoms that should alert providers, and specific considerations for FPMRS patients with suspected or confirmed COVID-19.ResultsBehavioral, medical, and conservative management will be valuable as first-line virtual treatments. Certain situations will require different treatments in the virtual setting while others will require an in-person visit despite the risks of COVID-19 transmission.ConclusionsWe have presented guidance for treating FPMRS conditions via telemedicine based on rapid literature review and expert consensus and presented it in a format that can be actively referenced.

Predictors of successful ring pessary use in women with pelvic organ prolapse.

Pelvic organ prolapse (POP) is a common chronic health issue. Pessary rings are used for conservative management. To date, there is little evidence on objective anatomical findings as predictors of successful ring pessary management. To determine any association between history, clinical and four-dimensional translabial ultrasound (TLUS)/pelvic floor ultrasound examination and pessary success. From November 2013 to November 1015, all new patients presenting with symptomatic prolapse to a tertiary urogynaecological unit underwent an assessment including interview, clinical examination, that is, International Continence Society POPQ (pelvic organ prolapse quantification) and TLUS. Women with symptomatic prolapse were offered conservative management with a ring pessary. Those who agreed had a ring inserted that day. Successful trial of pessary use was defined as continued use for at least threemonths. Retrospective analysis of imaging data was performed blinded to other data. Statistical analysis was performed to assess the relationship between history, examination and imaging and pessary success. Of 525 patients seen during the inclusion period, 177 had symptomatic prolapse. One hundred and twenty-eight were offered a pessary, 89 accepted. Five had incomplete data, leaving 84. Forty- Two(50%) werestill using the pessary at athree-month follow-up. Predictors associated with failure included being pre-menopausal (P=0.031), a previous hysterectomy (P=0.051), increasing genital hiatus and perineal body (Gh+Pb) (P=0.013), posterior compartment prolapse(P=0.027) and a larger hiatal area on Valsalva on TLUS (P=0.049). Pre-menopausal status (P=0.003), increasing Gh+Pb (P=0.011) and previous hysterectomy (P=0.001) remained significant on multivariate analysis. A history of previous hysterectomy is a predictor of pessary failure as are Gh+Pbon Valsalvaand premenopausal status.

Struvite “Sand” in the Vagina as Diagnostic Factor for New-onset Vesicovaginal Fistula and Pessary Management When Present

Struvite “Sand” in the Vagina as Diagnostic Factor for New-onset Vesicovaginal Fistula and Pessary Management When Present

Sexual function after prolapse repair.

The purpose of this review is to summarize available literature (from the last 18 months) assessing sexual function following pelvic reconstructive surgery for pelvic organ prolapse (POP). We include vaginal native tissue repair, abdominal/laparoscopic sacrocolpopexy, transvaginal mesh repair, and obliterative procedures. The goal is to assist providers in counseling patients and to identify areas needed for further research. When compared with pessary management, women who undergo POP surgical repair achieve their sexual function goals more often. In particular, vaginal native tissue repair has consistently been shown to improve sexual function. Furthermore, there does not appear to be a difference between uterosacral ligament suspension and sacrospinous ligament suspension (with or without uterine conservation) with regard to postoperative sexual function. Although less robust, literature evaluating the impact of abdominal/robotic sacrocolpopexy also supports benefit from surgical correction. However, data are conflicted with regard to transvaginal mesh repair and suggest the potential for a negative impact. POP often affects a woman's sexual function. Following surgical repair, most patients experience improvements in their sexual response. However, surgical approaches involving abdominal or transvaginal mesh may result in a decline in sexual function and worsening dyspareunia.

Arabin cervical pessary for prevention of preterm birth in cases of twin-to-twin transfusion syndrome treated by fetoscopic LASER coagulation: the PECEP LASER randomised controlled trial

BackgroundFetoscopic LASER coagulation of the placental anastomoses has changed the prognosis of twin-twin transfusion syndrome. However, the prematurity rate in this cohort remains very high. To date, strategies proposed to decrease the prematurity rate have shown inconclusive, if not unfavourable results.MethodsThis is a randomised controlled trial to investigate whether a prophylactic cervical pessary will lower the incidence of preterm delivery in cases of twin-twin transfusion syndrome requiring fetoscopic LASER coagulation. Women eligible for the study will be randomised after surgery and allocated to either pessary or expectant management. The pessary will be left in place until 37 completed weeks or earlier if delivery occurs. The primary outcome is delivery before 32 completed weeks. Secondary outcomes are a composite of adverse neonatal outcome, fetal and neonatal death, maternal complications, preterm rupture of membranes and hospitalisation for threatened preterm labour. 352 women will be included in order to decrease the rate of preterm delivery before 32 weeks’ gestation from 40% to 26% with an alpha-error of 0.05 and 80% power.DiscussionThe trial aims at clarifying whether the cervical pessary prolongs the pregnancy in cases of twin-twin transfusion syndrome regardless of cervical length at the time of fetoscopy.Trial registrationClinicalTrials.gov Identifier: NCT01334489. Registered 04 December 2011.