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

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

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

Cost-effectiveness of pessary therapy versus surgery for symptomatic pelvic organ prolapse: an economic evaluation alongside a randomised non-inferiority controlled trial.

OBJECTIVE: To evaluate the cost-effectiveness of pessary therapy as an initial treatment option compared with surgery for moderate to severe pelvic organ prolapse (POP) symptoms in secondary care from a healthcare and a societal perspective. DESIGN: Economic evaluation alongside a multicentre randomised controlled non-inferiority trial with a 24-month follow-up. SETTING: 21 hospitals in the Netherlands, recruitment conducted between 2015 and 2022. PARTICIPANTS: 1605 women referred to secondary care with symptomatic prolapse stage ≥2 were requested to participate. Of them, 440 women gave informed consent and were randomised to pessary therapy (n=218) or to surgery (n=222) in a 1:1 ratio stratified by hospital. INTERVENTIONS: Pessary therapy and surgery. PRIMARY AND SECONDARY OUTCOME MEASURES: The Patient Global Impression of Improvement (PGI-I), a 7-point scale dichotomised into successful versus unsuccessful, with a non-inferiority margin of -10%; quality-adjusted life-years (QALYs) measured by the EQ-5D-3L; healthcare and societal costs were based on medical records and the institute for Medical Technology Assessment questionnaires. RESULTS: For the PGI-I, the mean difference between pessary therapy and surgery was -0.05 (95% CI -0.14; 0.03) and -0.03 (95% CI -0.07; 0.002) for QALYs. In total, 54.1% women randomised to pessary therapy crossed over to surgery, and 3.6% underwent recurrent surgery. Healthcare and societal costs were significantly lower in the pessary therapy (mean difference=-€1807, 95% CI -€2172; -€1446 and mean difference=-€1850, 95% CI -€2349; -€1341, respectively). The probability that pessary therapy is cost-effective compared with surgery was 1 at willingness-to-pay thresholds between €0 and €20 000/QALY gained from both perspectives. CONCLUSIONS: Non-inferiority of pessary therapy regarding the PGI-I could not be shown and no statistically significant differences in QALYs between interventions were found. Due to significantly lower costs, pessary therapy is likely to be cost-effective compared with surgery as an initial treatment option for women with symptomatic POP treated in secondary care. TRIAL REGISTRATION NUMBER: NTR4883.

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

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

Involving people with a lived experience when developing a proposal for Health Technology Assessment research of nonsurgical treatments for pelvic organ prolapse: Process and reflections.

INTRODUCTION: Patient and public involvement (PPI) is an expectation when conducting research, including Health Technology Assessment (HTA), but practical guidance for those wishing to embed PPI into the grant application process is not always easily accessible. We wanted to ensure that PPI was central when preparing a proposal for an investigator-led evidence synthesis HTA investigating nonsurgical interventions for pelvic organ prolapse (POP) in women. Here, we describe our methods. METHODS: We recruited two patient co-applicants separately through an open process to help ensure that patient voice was present within our proposal's management and direction. We invited co-applicants to attend research team meetings and comment on the full proposal. We designed, recruited to and facilitated a scoping workshop, as well as undertook its subsequent evaluation. The insight shared within the workshop for patients with a lived experience of POP, including our patient co-applicants, helped us develop the scope and rationale behind our HTA proposal. We particularly considered the interventions to include within the evidence synthesis. We also considered the outcome measures for both the evidence synthesis and economic evaluation. We elicited ideas about where and how results could be disseminated. Feedback suggested the workshop was as valuable for the attendees as it was for the researchers, making them feel valued and listened to. The time spent by researchers working on the activity was substantial and not directly funded but a necessary and valuable activity in developing our potential HTA. Our work was informed using the UK Standards for Public Involvement and the Authors and Consumers Together Impacting on eVidencE (ACTIVE) framework. CONCLUSIONS: PPI can be enormously valuable in both developing and strengthening research proposals. However, further guidance is needed to help researchers recognise the level and type of involvement to use at this early stage, particularly given the large time investment needed to embed meaningful PPI. PATIENT AND PUBLIC CONTRIBUTION: Women with a lived experience of POP were involved at every stage of the grant application process; their involvement is documented in full throughout this work.

Long-term effects and costs of pelvic floor muscle training for prolapse: trial follow-up record-linkage study.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse affects around 40% of women aged over 50 years. A multicentre parallel group randomised trial (the Pelvic Organ Prolapse PhysiotherapY (POPPY) trial) demonstrated that pelvic floor muscle training (PFMT) was effective in reducing prolapse symptoms compared with no treatment. However, insight into the long-term impact of PFMT on health outcomes and health-service utilisation is scarce. METHODS: This study utilised linkage of Scottish administrative health records to follow-up POPPY trial participants resident in Scotland over 11 years. Mixed effects logistic regression determined the likelihood of receiving further prolapse treatment for those in the PFMT and control groups. Analyses were adjusted for age group, prolapse stage, baseline symptom severity and attitude towards surgery. A cost assessment estimated longitudinal costs to the UK National Health Service (in Scotland) of accessing further prolapse treatment for each trial group. RESULTS: Two hundred and ninety-three women, aged 25 to 79 years, were followed up. One hundred and forty-one women (48.1%) had received further prolapse treatment: 65 (of 149; 43.6%) in the PFMT group compared with 76 (of 144; 52.8%) in the control group. PFMT was associated with a reduction in the odds of any prolapse treatment during follow-up (AOR 0.61; 95% CI 0.37 to 0.99). Total cost of secondary care was £154,544 (GBP) in the PFMT group and £172,549 (GBP) in the control group. CONCLUSIONS: Although PFMT did not lead to significant differences in total costs for further prolapse treatment over a post-intervention period of more than 10 years, it reduced the overall long-term risk of requiring hospital-based treatment for pelvic floor disorders.

Effectiveness of intravaginal electrical stimulation combined with electromyography biofeedback-mediated pelvic floor muscle training for postpartum symptomatic pelvic organ prolapse: protocol for the PROSPECT randomized trial.

BACKGROUND: Pelvic organ prolapse (POP) is seen in up to 30-70% of women presenting for routine gynecology care and 10% of women suffering from bothersome POP symptoms. Vaginal childbirth is one of the most prominent contributing factors for POP. Pelvic muscle training (PFMT) is considered effective to improve mild to moderate POP symptoms. In addition, higher-intensity, supervised PFMT aided by biofeedback and electrical stimulation may confer greater benefit. However, the long-term efficacy of the PFMT combined with electromyography biofeedback is unknown, which indicates the need for further evidence. METHODS: This multicenter randomized controlled trial compares the effectiveness and cost-effectiveness of conventional PFMT versus biofeedback-mediated PFMT plus neuromuscular electrical stimulation (NMES) for postpartum symptomatic POP women. The primary outcome is the proportion of patients with the improvement of at least one POP-Q stage at 36 months after randomization. The primary economic outcome measure is incremental cost per quality-adjusted life year at 36 months. Two hundred seventy-four women from four outpatient medical centers are randomized and followed up with pelvic floor examination, questionnaires, and pelvic ultrasonography imaging. All participants are arranged for three appointments over 12 weeks. NMES and electromyography biofeedback via intravaginal probe are added to PFMT for participants in the biofeedback-mediated PFMT group. Group allocation could not be blinded from participants and healthcare staff that deliver intervention but remain masked from medical staff that carry out PFM assessment. An intention-to-treat analysis of the primary outcome will estimate the difference of the proportion of POP-Q stage improvement between the trial groups right after the intervention, and during the follow-up until 36 months, using the chi-square test and multilevel mixed models respectively. A logistic regression analysis was used for adjusting for important baseline variables that are unbalanced. DISCUSSION: The trial results will provide evidence of the effectiveness of electromyography biofeedback-mediated PFMT in improving women's POP-Q staging, quality of life, and cost-effectiveness. TRIAL REGISTRATION: CCTR Registry ChiCTR210002171917 . Registered on March 6, 2019.

Cross sectional study on assessment of ring pessary cleaning and removal every six months: adverse events and complications.

INTRODUCTION AND HYPOTHESIS: Despite its frequent use, there is little evidence of adequate management of pessaries for treating pelvic organ prolapse (POP). Thus, the aims the study were to assess the rate of complications in women using ring-type pessaries with cleaning and monitoring every 6 months and to correlate the time of use of the pessary with possible complications. METHODS: This is a cross-sectional study including women diagnosed with stage 3 or 4 genital prolapse, who were already in outpatient follow-up and who used a ring pessary. We excluded patients using another type of pessary, with severe comorbidities and with POP-Q ≤ 2 staging. The chi-square test or Fisher exact test was applied for categorical variables, the t-test for continuous variables with normal distribution and Mann-Whitney test for non-parametric variables. RESULTS: A total of 83 women using a ring pessary were assessed. The mean in months of pessary use was 31.8 ± 14.9 months. Vaginal discharge was the most frequent complaint representing 26.5%, followed by foul smell in 13.3%. No significant correlation was found between length of pessary use and clinical variables. However, a significant correlation was found between immediate complications and the length of pessary use (21.3 ± 5.9 months; p < 0.0044). CONCLUSION: There was no increase in complication rate in the continuous use of a ring pessary with cleaning and monitoring every 6 months. Determining a follow-up time that reduces the risk of complications is necessary not only for the organization of the attendance services, allowing a greater number of monitored patients, but also for the access of patients who need regular monitoring.

Vaginal Pessaries for Pelvic Organ Prolapse or Stress Urinary Incontinence: A Health Technology Assessment.

BACKGROUND: Pelvic organ prolapse (POP) is the downward descent of the female pelvic organs into or through the vagina. The symptom that most strongly correlates with and is most specific for POP is a feeling of vaginal bulging. Stress urinary incontinence (SUI) is an involuntary loss of urine upon physical exertion or sneezing or coughing. Conservative (non-surgical) treatment options for both conditions include vaginal pessaries. We conducted a health technology assessment of vaginal pessaries for the treatment of POP and SUI, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding vaginal pessaries, and patient preferences and values. METHODS: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using ROBIS, the Cochrane Risk of Bias tool, and the Newcastle-Ottawa Scale and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted a cost-utility analysis with a 10-year horizon from a public payer perspective. We also analyzed the budget impact of publicly funding vaginal pessaries for individuals with pelvic organ prolapse and/or stress urinary incontinence in Ontario. We explored the underlying values, needs, and priorities of those who have lived experience with POP and/or SUI, as well as the preferences and perceptions of both patients and providers of vaginal pessaries. RESULTS: We included 15 studies in the clinical evidence review. Compared with no treatment for people with SUI, pessaries were associated with a significant improvement in some symptoms at 14 days follow-up (SUI subscore of Urinary Symptom Profile, mean difference -2.20; 95% CI -3.47 to -0.93; GRADE: Very low). Compared with pelvic floor muscle training (PFMT), pessaries were associated with no difference in improvement at 12 months follow-up for some symptoms (Urinary Distress Inventory subscale of the Pelvic Floor Distress Inventory, risk ratio = 0.86; 95% CI 0.64 to 1.16; GRADE: Low). For people with POP, pessaries were associated with a significant improvement in the Pelvic Organ Prolapse Distress Inventory score and in sexual function compared with PFMT plus feedback/electrical stimulation/lifestyle advice at 12- and 24-month follow ups (GRADE: Low). Pessary continuation rate at 12 months follow up was reported to be 60% (44/74 patients) (GRADE: Very low).When evaluating various POP and SUI treatments in sequential order, pessaries were within the most cost-effective treatment sequence; therefore, it is likely to be a cost-effective intervention for treating POP and SUI. There was a high degree of certainty that pessaries were cost-effective in a population with POP, and a moderate degree of certainty in a population with SUI. When the treatment sequence of pessaries and surgery was compared with surgery alone, the pessaries treatment sequence dominates surgery in the cohort with POP, and in the cohort with SUI pessaries had an incremental cost-effectiveness ratio (ICER) of $1,033 per QALY gained. The annual budget impact of publicly funding vaginal pessaries in Ontario over the next 5 years ranges from $0.3 million in year 1 to $0.5 million in year 5 for POP, and $0.2 million in year 1 to $0.3 million in year 5 for SUI.We included one study in our quantitative evidence review and spoke to 29 people in our direct patient engagement. The evidence indicated that patient preferences vary and that patients accept the risks of their chosen treatment option. The 24 people we spoke with who had direct experience with vaginal pessaries reported that their POP and/or SUI limited their social activities and restricted their activity levels, taking a huge emotional toll. Many were hesitant or even fearful of surgery due to side effects and perceived failure rate of the surgery. Most people reported that pessaries relieved most or all of their symptoms, allowing them to return to their normal daily activities. However, wait times for pessary fittings could be as long as 2 years, and out-of-pocket expenses could be a barrier for people without extended insurance. CONCLUSIONS: For people with SUI, vaginal pessaries may improve symptoms compared with no treatment, but the evidence is very uncertain. Pessaries may result in little to no difference in longer-term improvement of SUI symptoms compared with PFMT. For people with POP, pessaries may improve some longer-term symptoms, as well as sexual function compared with PFMT. For people with symptomatic POP and SUI, vaginal pessaries may be a cost-effective intervention to be used within a stepped care model (a sequence of interventions followed after the current treatment proves ineffective). We estimate that publicly funding vaginal pessaries in Ontario would result in a total 5-year budget impact of $2.0 million for POP and $1.3 million for SUI. People with POP and/or SUI reported pessary use as being an effective treatment option to manage their symptoms.

Pessaries (mechanical devices) for managing pelvic organ prolapse in women.

BACKGROUND: Pelvic organ prolapse is a common problem in women. About 40% of women will experience prolapse in their lifetime, with the proportion expected to rise in line with an ageing population. Women experience a variety of troublesome symptoms as a consequence of prolapse, including a feeling of 'something coming down' into the vagina, pain, urinary symptoms, bowel symptoms and sexual difficulties. Treatment for prolapse includes surgery, pelvic floor muscle training (PFMT) and vaginal pessaries. Vaginal pessaries are passive mechanical devices designed to support the vagina and hold the prolapsed organs back in the anatomically correct position. The most commonly used pessaries are made from polyvinyl-chloride, polythene, silicone or latex. Pessaries are frequently used by clinicians with high numbers of clinicians offering a pessary as first-line treatment for prolapse.  This is an update of a Cochrane Review first published in 2003 and last published in 2013. OBJECTIVES: To assess the effects of pessaries (mechanical devices) for managing pelvic organ prolapse in women; and summarise the principal findings of relevant economic evaluations of this intervention. SEARCH METHODS: We searched the Cochrane Incontinence Specialised Register which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 28 January 2020). We searched the reference lists of relevant articles and contacted the authors of included studies. SELECTION CRITERIA: We included randomised and quasi-randomised controlled trials which included a pessary for pelvic organ prolapse in at least one arm of the study. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed abstracts, extracted data, assessed risk of bias and carried out GRADE assessments with arbitration from a third review author if necessary. MAIN RESULTS: We included four studies involving a total of 478 women with various stages of prolapse, all of which took place in high-income countries. In one trial, only six of the 113 recruited women consented to random assignment to an intervention and no data are available for those six women. We could not perform any meta-analysis because each of the trials addressed a different comparison. None of the trials reported data about perceived resolution of prolapse symptoms or about psychological outcome measures. All studies reported data about perceived improvement of prolapse symptoms. Generally, the trials were at high risk of performance bias, due to lack of blinding, and low risk of selection bias. We downgraded the certainty of evidence for imprecision resulting from the low numbers of women participating in the trials. Pessary versus no treatment: at 12 months' follow-up, we are uncertain about the effect of pessaries compared with no treatment on perceived improvement of prolapse symptoms (mean difference (MD) in questionnaire scores -0.03, 95% confidence interval (CI) -0.61 to 0.55; 27 women; 1 study; very low-certainty evidence), and cure or improvement of sexual problems (MD -0.29, 95% CI -1.67 to 1.09; 27 women; 1 study; very low-certainty evidence). In this comparison we did not find any evidence relating to prolapse-specific quality of life or to the number of women experiencing adverse events (abnormal vaginal bleeding or de novo voiding difficulty). Pessary versus pelvic floor muscle training (PFMT): at 12 months' follow-up, we are uncertain if there is a difference between pessaries and PFMT in terms of women's perceived improvement in prolapse symptoms (MD -9.60, 95% CI -22.53 to 3.33; 137 women; low-certainty evidence), prolapse-specific quality of life (MD -3.30, 95% CI -8.70 to 15.30; 1 study; 116 women; low-certainty evidence), or cure or improvement of sexual problems (MD -2.30, 95% -5.20 to 0.60; 1 study; 48 women; low-certainty evidence). Pessaries may result in a large increase in risk of adverse events compared with PFMT (RR 75.25, 95% CI 4.70 to 1205.45; 1 study; 97 women; low-certainty evidence). Adverse events included increased vaginal discharge, and/or increased urinary incontinence and/or erosion or irritation of the vaginal walls. Pessary plus PFMT versus PFMT alone: at 12 months' follow-up, pessary plus PFMT probably leads to more women perceiving improvement in their prolapse symptoms compared with PFMT alone (RR 2.15, 95% CI 1.58 to 2.94; 1 study; 260 women; moderate-certainty evidence). At 12 months' follow-up, pessary plus PFMT probably improves women's prolapse-specific quality of life compared with PFMT alone (median (interquartile range (IQR)) POPIQ score: pessary plus PFMT 0.3 (0 to 22.2); 132 women; PFMT only 8.9 (0 to 64.9); 128 women; P = 0.02; moderate-certainty evidence). Pessary plus PFMT may slightly increase the risk of abnormal vaginal bleeding compared with PFMT alone (RR 2.18, 95% CI 0.69 to 6.91; 1 study; 260 women; low-certainty evidence). The evidence is uncertain if pessary plus PFMT has any effect on the risk of de novo voiding difficulty compared with PFMT alone (RR 1.32, 95% CI 0.54 to 3.19; 1 study; 189 women; low-certainty evidence). AUTHORS' CONCLUSIONS: We are uncertain if pessaries improve pelvic organ prolapse symptoms for women compared with no treatment or PFMT but pessaries in addition to PFMT probably improve women's pelvic organ prolapse symptoms and prolapse-specific quality of life. However, there may be an increased risk of adverse events with pessaries compared to PFMT. Future trials should recruit adequate numbers of women and measure clinically important outcomes such as prolapse specific quality of life and resolution of prolapse symptoms.   The review found two relevant economic evaluations. Of these, one assessed the cost-effectiveness of pessary treatment, expectant management and surgical procedures, and the other compared pessary treatment to PFMT.

Clinical and cost-effectiveness of vaginal pessary self-management compared to clinic-based care for pelvic organ prolapse: protocol for the TOPSY randomised controlled trial.

BACKGROUND: Pelvic organ prolapse (or prolapse) is a common condition in women where the pelvic organs (bladder, bowel or womb) descend into the vagina and cause distressing symptoms that adversely affect quality of life. Many women will use a vaginal pessary to treat their prolapse symptoms. Clinic-based care usually consists of having a pessary fitted in a primary or secondary care setting, and returning approximately every 6 months for healthcare professional review and pessary change. However, it is possible that women could remove, clean and re-insert their pessary themselves; this is called self-management. This trial aims to assess if self-management of a vaginal pessary is associated with better quality of life for women with prolapse when compared to clinic-based care. METHODS: This is a multicentre randomised controlled trial in at least 17 UK centres. The intervention group will receive pessary self-management teaching, a self-management information leaflet, a follow-up phone call and access to a local telephone number for clinical support. The control group will receive the clinic-based pessary care which is standard at their centre. Demographic and medical history data will be collected from both groups at baseline. The primary outcome is condition-specific quality of life at 18 months' post-randomisation. Several secondary outcomes will also be assessed using participant-completed questionnaires. Questionnaires will be administered at baseline, 6, 12 and 18 months' post-randomisation. An economic evaluation will be carried out alongside the trial to evaluate cost-effectiveness. A process evaluation will run parallel to the trial, the protocol for which is reported in a companion paper. DISCUSSION: The results of the trial will provide robust evidence of the effectiveness of pessary self-management compared to clinic-based care in terms of improving women's quality of life, and of its cost-effectiveness. TRIAL REGISTRATION: ISRCTN Registry ISRCTN62510577 . Registered on June 10, 2017.

Assessment of the urogynaecology patient in primary care and when to refer.

Urogynaecological symptoms are commonly encountered problems in women of post-reproductive age, which have a major impact on quality of life in affected women. This review summarises a standardised approach to common urogynaecological problems in primary care, which focuses on making the correct diagnosis, assessing impact, evaluating for other relevant lifestyle and medical factors and indications for referral into secondary care.

The effect of diagnosis-related group payment system on the quality of medical care for pelvic organ prolapse in Korean tertiary hospitals.

PURPOSE: To assess changes in clinical practice patterns after implementing diagnosis-related group (DRG) payment system in July 2013 and its effect on the quality of care for pelvic organ prolapse (POP). MATERIALS AND METHODS: Using the 2011-2016 administrative database from National Health Insurance claim data, we reviewed medical information of 7362 patients who underwent hysterectomies for POP in Korean tertiary hospitals. We compared changes in several variables including length of stay, concomitant procedures, outpatient visits and readmission within 30 days after discharge, and retreatment for POP or stress urinary incontinence within postoperative 1 year before and after DRG system. RESULTS: After the introduction of DRG system, the average length of stay decreased (7.74 ± 2.88 to 6.63 ± 2.18 days, p<0.001) without increasing readmission rates. However, the number of outpatient visits increased (2.78±2.33 to 2.98±2.47, p<0.001). Regarding concomitant procedures, the rates of colpopexy and midurethral slings significantly decreased (7.87% and 9.84% to 4.93% and 2.93%, respectively, all p<0.001). Even though there was no difference in the reoperation rates, pessary insertion for recurrent POP significantly increased after the introduction of DRG system (0.10% to 0.38%, p = 0.015). CONCLUSION: The implementation of DRG in Korean tertiary hospitals has led to increase of outpatient visits and reduced surgical management for POP, which indicates that the uniform application of DRG influences the quality of care for POP patients.

All Levels of Providers Can Effectively and Efficiently Teach Pelvic Floor Strength Assessment at Time of Pelvic Examination.

OBJECTIVE: In women who undergo provider-guided vaginal biofeedback of pelvic floor muscle strength, we sought to determine whether the level of the provider correlates with the patient's ability to achieve adequate pelvic floor muscle contractions (PFMCs). METHODS: From August 2017 to April 2018, patients from 2 urogynecology clinics were recruited to participate in an institutional review board-approved, prospective study examining PFMCs. Pelvic examination and teaching session were done by providers who had specific training on how to assess pelvic floor muscle strength using the validated, modified Oxford scale. Patients were asked to perform a baseline PFMC during a 2-digit pelvic examination. Thereafter, patients were counseled to relax their muscles, identify the levator ani muscles during provider teaching, and perform 3 consecutive provider-guided PFMCs. The strength of each PFMC was measured, and the time-to-teach (TTT) was recorded. The level of provider and TTT were correlated with PFMC1 to PFMC3 using Spearman correlation coefficient. RESULTS: One hundred women participated. Obstetrics/gynecology (OB/GYN) residents (post-graduate years 1-4) evaluated 20 patients; female pelvic medicine and reconstructive surgery fellowship trainees (post-graduate years 5-7), 38 patients; OB/GYN nurse practitioners, 18 patients; generalist OB/GYN faculty, 9 patients; and female pelvic medicine and reconstructive surgery faculty, 15 patients. There was no correlation between level of provider and TTT or between level of provider and strength of PFMC1, PFMC2, or PFMC3. CONCLUSIONS: At the time of pelvic floor muscle assessment, the level of provider does not impact teaching time or PFMC1 to PFMC3. Teaching pelvic floor muscle exercise is a cost-effective, low-resource tool to improve patient care, and providers of any level should be encouraged to teach pelvic floor muscle exercise to patients at the time of office examination.

Pelvic organ prolapse and urogynecological assessment in women with spinal cord injury.

STUDY DESIGN: Observational cross-sectional study. OBJECTIVES: Due to weakened pelvic floor muscles, the risk of pelvic organ prolapse (POP) may increase after a spinal cord injury (SCI); hence, the aim of this study was to investigate the occurrence of POP after SCI and to evaluate the need for urogynecological consultations offered to women with SCI. SETTING: Clinic for Spinal Cord Injuries, Rigshospitalet, Denmark. METHODS: Women with SCI who visited our SCI-clinic during January 2013-January 2018 were offered a specialized urogynecological consultation. Any symptoms of POP, urinary/fecal incontinence, or bladder/bowel emptying problems were registered, and POP was classified according to the POP quantification system during a pelvic examination. Differences in baseline characteristics between women with POP stage 0-1 and POP stage ≥2 were investigated. RESULTS: A total of 98 women were included in the study. Fourteen women (14%) reported POP symptoms and 21 women (21%) had anatomical POP stage ≥2. The group with POP stage ≥2 had a significantly higher age, higher parity, more with vaginal delivery, and more postmenopausal women, but the groups did not differ on median time after injury, neurological level, and completeness of injury. A total of 71% experienced urinary incontinence, 27% experienced fecal incontinence, 63% experienced bladder emptying problems, and 70% experienced bowel emptying problems. Consequently, 65% received treatment. CONCLUSIONS: Women with SCI are not in increased risk of developing anatomical POP. Nonetheless, the high occurrence of other urogynecological issues and the high treatment-rate supports the need for specialized urogynecological consultations offered to women with SCI.

Demand and capacity to integrate pelvic organ prolapse and genital fistula services in low-resource settings.

INTRODUCTION AND HYPOTHESIS: There is a need for expanded access to safe surgical care in low- and middle-income countries (LMICs) as illustrated by the report of the 2015 Lancet Commission on Global Surgery. Packages of closely-related surgical procedures may create platforms of capacity that maximize impact in LMIC. Pelvic organ prolapse (POP) and genital fistula care provide an example. Although POP affects many more women in LMICs than fistula, donor support for fistula treatment in LMICs has been underway for decades, whereas treatment for POP is usually limited to hysterectomy-based surgical treatment, occurring with little to no donor support. This capacity-building discrepancy has resulted in POP care that is often non-adherent to international standards and in non-integration of POP and fistula services, despite clear areas of similarity and overlap. The objective of this study was to assess the feasibility and potential value of integrating POP services at fistula centers. METHODS: Fistula repair sites supported by the Fistula Care Plus project were surveyed on current demand for and capacity to provide POP, in addition to perceptions about integrating POP and fistula repair services. RESULTS: Respondents from 26 hospitals in sub-Saharan Africa and South Asia completed the survey. Most fistula centers (92%) reported demand for POP services, but many cannot meet this demand. Responses indicated a wide variation in assessment and grading practices for POP; approaches to lower urinary tract symptom evaluation; and surgical skills with regard to compartment-based POP, and urinary and rectal incontinence. Fistula surgeons identified integration synergies but also potential conflicts. CONCLUSIONS: Integration of genital fistula and POP services may enhance the quality of POP care while increasing the sustainability of fistula care.

The prevalence and treatment pattern of clinically diagnosed pelvic organ prolapse: a Korean National Health Insurance Database-based cross-sectional study 2009-2015.

The study aim was to evaluate the prevalence of pelvic organ prolapse using claim data of South Korea and to evaluate treatment patterns. The Korea National Health Insurance Corporation pay medical costs for most diseases. This study used Health Insurance Review & Assessment Service-National Inpatient Sample (HIRA-NIS) 2009-2015. Pelvic organ prolapse was defined by diagnostic code (N81.x). Of the approximately 4.5 million women included in HIRA-NIS 2009-2015, 10,305 women were selected as having pelvic organ prolapse, and the mean age of the pelvic organ prolapse group was 63.9 ± 0.2 years. The prevalence of pelvic organ prolapse was 180 ± 4 per 100,000 population in women older than 50 years old. In logistic regression analysis, constipation increased the prevalence of all pelvic organ prolapse (odds ratio, 4.04; 95% confidence interval, 3.52-4.63; P < 0.01). The number of women requiring pessary only and surgery only were 26 ± 2 per 100,000 population and 89 ± 1 per 100,000 population, respectively, for women over 50 years of age. The prevalence of pelvic organ prolapse was quite lower than in previous studies. Surgery peaked at approximately 70 years of age. Pessary increased dramatically among women after the age of 65.

Assessment of overactive bladder symptoms among women with successful pessary placement.

INTRODUCTION AND HYPOTHESIS: The causal association between pelvic organ prolapse (POP) and overactive bladder (OAB) symptoms is supported by several theories. The aim of this study is to assess any changes in OAB symptoms among women with POP and OAB after successful pessary placement. METHODS: During the study period, all women with symptomatic POP stage II or greater and OAB symptoms were offered the solution of either a ring or a Gellhorn pessary. All patients were asked to complete a 3-day micturition/incontinence diary. Objective evaluation endpoints at baseline and at 6 weeks included: change in the mean number of micturitions/24 h, change in the mean volume voided per micturition/24 h, and change in the number of urinary incontinence episodes. Subjective evaluation of the urgency, frequency, and nocturia symptoms was carried out using the score change of the questions 3, 5, and 2 of the International Consultation on Incontinence Questionnaire for Evaluating Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) respectively. RESULTS: Seventy-four women were included in the study. A statistically significant decrease (-28.3%; p < 0.001) of the mean number of micturitions/24 h with a significant increase (37%; p < 0.001) in the mean voided volume per micturition/24 h was observed. The total urine volume/24 h remained unchanged. The number of urinary incontinence episodes was significantly increased 6 weeks after pessary placement (p < 0.001). De novo stress urinary incontinence (SUI) was reported by 16.7% of the initially stress continent women. CONCLUSIONS: Women with coexisting POP and OAB symptoms may experience a significant improvement in micturition frequency and in urgency and frequency symptoms after successful pessary fitting.

PROPEL: implementation of an evidence based pelvic floor muscle training intervention for women with pelvic organ prolapse: a realist evaluation and outcomes study protocol.

BACKGROUND: Pelvic Organ Prolapse (POP) is estimated to affect 41%-50% of women aged over 40. Findings from the multi-centre randomised controlled "Pelvic Organ Prolapse PhysiotherapY" (POPPY) trial showed that individualised pelvic floor muscle training (PFMT) was effective in reducing symptoms of prolapse, improved quality of life and showed clear potential to be cost-effective. However, provision of PFMT for prolapse continues to vary across the UK, with limited numbers of women's health physiotherapists specialising in its delivery. Implementation of this robust evidence from the POPPY trial will require attention to different models of delivery (e.g. staff skill mix) to fit with differing care environments. METHODS: A Realist Evaluation (RE) of implementation and outcomes of PFMT delivery in contrasting NHS settings will be conducted using multiple case study sites. Involving substantial local stakeholder engagement will permit a detailed exploration of how local sites make decisions on how to deliver PFMT and how these lead to service change. The RE will track how implementation is working; identify what influences outcomes; and, guided by the RE-AIM framework, will collect robust outcomes data. This will require mixed methods data collection and analysis. Qualitative data will be collected at four time-points across each site to understand local contexts and decisions regarding options for intervention delivery and to monitor implementation, uptake, adherence and outcomes. Patient outcome data will be collected at baseline, six months and one year follow-up for 120 women. Primary outcome will be the Pelvic Organ Prolapse Symptom Score (POP-SS). An economic evaluation will assess the costs and benefits associated with different delivery models taking account of further health care resource use by the women. Cost data will be combined with the primary outcome in a cost effectiveness analysis, and the EQ-5D-5L data in a cost utility analysis for each of the different models of delivery. DISCUSSION: Study of the implementation of varying models of service delivery of PFMT across contrasting sites combined with outcomes data and a cost effectiveness analysis will provide insight into the implementation and value of different models of PFMT service delivery and the cost benefits to the NHS in the longer term.

Impact of Distance to Treatment Center on Care Seeking for Pelvic Floor Disorders.

OBJECTIVE: The aim of this study was to evaluate the impact of distance from residence to treatment center on access to care for female pelvic floor disorders at an academic institution. METHODS: A retrospective cross-sectional study was conducted of women seen for pelvic floor disorders at an academic institution from 2008 to 2014. Patient characteristics were extracted from charts. Geographical and US census data was obtained from public records and used to calculate distance from patient residence to physician office. Statistical analysis was performed using R Software (Version 0.98.1102) and Microsoft Excel (Version 14.4.7). Statistical significance was defined as a 2-sided P value of less than 0.05, and the χ test was used to determine associations of categorical variables. RESULTS: A total of 3015 patients were included in the analysis. The mean distance traveled was 93 miles. Thirty percent of patients traveled more than 50 miles. Many patients (43%) reported having the symptoms for more than 2 years. Patients who traveled farther were significantly more likely to be white, English-speaking, and with pelvic organ prolapse as primary complaint. These patients were more likely to plan surgery at the first visit than patients who traveled less far (29% vs 14%). Patients who traveled farther were also more likely to live in counties with a low percentage of persons older than 65 years and low percentage of female inhabitants. CONCLUSIONS: Women who travel the farthest for treatment of pelvic floor disorders have experienced the symptoms for longer duration and are more willing to plan surgery at presentation. These women also come from counties with fewer elderly women, suggesting future outreach care should focus on similar geographic areas.

Are women's needs being met by specialist health services managing urinary incontinence in the remote Top End NT?

BACKGROUND: Urinary incontinence (UI) is likely to be high in Aboriginal women in rural Australia due to risk factors including high body mass index, parity and diabetes. However, UI appears to be under-reported with limited information on whether women access appropriate care. AIMS: To assess whether women who access specialist gynaecological services in rural and remote Top End Northern Territory (NT) through the specialist outreach program (SONT) are receiving care for UI aligned with best practice. METHODS: Review of all 1426 SONT referrals in 2012, with audit of management for those women referred for UI or prolapse. RESULTS: Of 1426 SONT referrals, there were 43/1426 (3%) women referred for UI, with 34/43 (79%) attending. Of those referred, 31/43 (72%) were Aboriginal. Of twenty-six women diagnosed with probable stress UI, less than a fifth, 5/26 (19%), were referred to physiotherapy, with 2/5 (40%) attending appointments. Referral occurred for 14/23 (61%) of those suitable for urodynamics but only 6/14 (43%) attended. Just under half of women 7/16 (14%) with stress UI were referred for surgery, with 6/7 (86%) attending. CONCLUSION: In rural and remote Top End NT, specialist health service management of female UI could be improved by increased provision of current best-practice and an integrated multi-disciplinary team approach with allied health. Under-reporting and under-referral for female UI could be addressed by increasing awareness among community and primary healthcare providers of the problem of female UI and the conservative, medical and surgical treatments available.